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出境医 / 临床实验 / Oral Health Condition and Quality of Life in Children With Leukemia

Oral Health Condition and Quality of Life in Children With Leukemia

Study Description
Brief Summary:
Among the different types of cancer that most affect children, leukemia is the principal. One of the main treatments for leukemia is chemotherapy. Among the most common side effects of chemotherapy are nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis. It is still necessary to establish which microorganisms are predominant in the oral microbiota of children with leukemia, which factors influence it, what is its relationship with oral mucositis and what is their impact in the quality of life. To better understand the risks of secondary infection, it is important to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that may negatively impact the quality of life, to expose the risk of death as well as raise hospital costs for the care of children with leukemia. Objective: To identify the clinical characteristics of the oral condition, types of microorganisms of the oral microbiota, and quality of life in children/adolescents with acute lymphoid leukemia and acute myeloid leukemia before and during antineoplastic treatment, and compare them with healthy children/adolescent individuals. Methodology: Longitudinal, case-control study, with a convenience sample. The study group, composed of children/adolescent individuals who have a definitive diagnosis of acute lymphoid leukemia or acute myeloid leukemia. The control group, non-syndromic children/adolescents, with no history of cancer, matched by age and gender. The clinical condition of the mouth will be evaluated by means of indexes: dental caries index (dmft index), gingival index (GA), and simplified oral hygiene index. The assessment of the quality of life through the ohip-14 and POS-version14 quality of life questionnaire and microbiological evaluation of saliva through MALDI-TOF analysis. Statistical analysis will be performed through relative risk for cohort study with more than three paired groups. Odds ratio, for the control group more than three controlled groups and Mcnemere, for comparison with the control group, for more than three paired groups.

Condition or disease Intervention/treatment
Leukemia, Lymphoblastic Leukemia, Myeloid, Acute Other: This study is observational

Detailed Description:

In children, non-communicable diseases such as cancer are increasing every year. It became a priority on the global child health agenda. Each year, there were an estimated 30.000 new cases of cancer in children/adolescent individuals. In Brazil, between 2018-2019, there were 12.500 new cases of cancer in children and adolescents up to 19 years of age. The mortality rate was 7.917 cases.

Among the types of cancer that most affect children, leukemia is the most prevalent. In 2018, there was a forecast of 437.033 new cases of leukemia with a mortality of 309.006 individuals around the world.

One of the main treatments for leukemia is chemotherapy, the side effects can affect different parts of the body that may present since the beginning of the treatment. Chemotherapy produces systemic toxicity resulting in anemia, leukopenia, and thrombocytopenia that is more intense in the treatment of oncohematological diseases when compared to solid tumors. Among the most common side effects of chemotherapy are included nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis.

Some studies reported that the intensity of oral mucositis, as well as the risk of sepsis from secondary infection in the mouth of individuals with cancer, they can be influenced by some specific microorganisms present in the oral cavity. Factors such as oral hygiene, presence of dental caries, and periodontal disease may be related to the type of microorganisms present in the oral cavity. There is a lack of studies about microbiota oral in leukemic children. Oral microbiota in children with leukemia is predominantly composed of gram-positive microorganisms such as Streptococus viridans, Streptococous mutans and Lactobacillus when compared to adults oral microbiota where gram-negatives microorganisms such as Klebsiella spp., E coli, Enterobacter, Pseudomonas spp. predominate. It is noteworthy that it is necessary to establish what kind of microorganisms are predominant in the oral microbiota of children with leukemia, also which factors influence it, and what is the relationship among the oral mucositis, general clinical status, and quality of life of the children/adolescent with cancer.

Therefore, it is important to identify the risks of secondary infection in oral cavity, to be able to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that can negatively impact the quality of life, expose the risk of death as well as raise hospital costs for the care of children with leukemia.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 3 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Clinical-microbiological Study of Oral Health Condition and Quality of Life of Children/Adolescent With Acute Lymphoid Leukemia and Acute Myeloid
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : July 8, 2021
Estimated Study Completion Date : December 17, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Study group
Composed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender.
 Other: This study is observational
  • Clinical evaluation of the oral health condition
  • Microbiota evaluation by analyzing the collected saliva
  • Application of questionnaires of quality of life
Control group
The control group is going to consist of healthy children/adolescent individuals, non-syndromic, without history of cancer, matched by age and gender in relation to the study group, who have not used antibiotics 48 hours before or in the day of evaluation.
 Other: This study is observational
  • Clinical evaluation of the oral health condition
  • Microbiota evaluation by analyzing the collected saliva
  • Application of questionnaires of quality of life
Outcome Measures
Primary Outcome Measures :
  1. Evaluation of dental condition [ Time Frame: 5 minutes to 10 minutes ]
    Dental condition is going to be evaluated by dental caries index (dmft index) (WHO, 2013).

  2. Evalulation of periodontal condition [ Time Frame: 10 minutes to 15 minutes ]
    The periodontal evaluation it is goning to be evaluated by and gingival index (LOE, 1964)

  3. Evalulation of oral hygiene [ Time Frame: 10 minutes to 15 minutes ]
    Oral hygiene is going to be evaluated by simplified oral hygiene index (IHO-S).

  4. To evaluate oral mucositis [ Time Frame: 5 minutes to 10 minutes ]
    the presence of oral mucositis will be evaluated through the graduation recommended by the World Health Organization (WHO) (WHO, 1979).

  5. Evaluation of oral pain of oral mucositis [ Time Frame: 1 minutes to 2 minutes ]
    The oral pain because of the oral mucositis is going to be evaluated by Visual Analogue Scael of pain and it is gonig to be scaled by the Wong-Backer face scale which is from 0 to 10 pontuation, being 1 the minimium pain percivied and 10 de maximium pain percieved. This evaluation it is going to be make only in children with leukemia.

  6. Saliva collection [ Time Frame: 15 minutes to 20 minutes ]
    The collection of the saliva is going to be made by an unstimulated technic. The minimum of 2 mL to maximum of 10 ml of saliva are going to be collected.

  7. to evaluate the quality of life of children percieved by parents [ Time Frame: 10 to 15 minutes ]
    A Pediatric Quality of Life Inventory Version 4.0 questionaire is going to be answered by children parentes with the following five options: never = 0, almost never = 1, sometimes = 2, often = 3, and almost always = 4.

  8. to evaluate the impact of oral condition on the quality of life percieved by the children [ Time Frame: 10 to 15 minutes ]
    A OHIP-14 (Oral Health Impact Profile) questionnaire (adapted for children) is going to be applied to children with 6 years old or children older than 6 years old. The questionaire is going to be answered with five options: never = 0, almost never =1 , sometimes = 2, often = 3, and almost always = 4 which is represented by a face scale.


Biospecimen Retention:   Samples With DNA
There are going to collect saliva for this study, which is going to be stored for 10 years as the maximum limit.

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study group will be composed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender.
Criteria

Inclusion Criteria:

  • Patients who, based on the agreement of parents and/or guardians, agree to participate in the research with a signed "Informed Consent Form"
  • Patients from 3 to 17 years of age
  • Patients older than 6 years must not only have parental and/or guardian authorization must have the consent term
  • Patients who have not started antineoplastic treatment
  • Patients with ALL only with BFM protocol
  • AML patients with BFM protocol only

Exclusion Criteria:

  • Responsible for patients who do not sign the free and informed consent form.
  • Patients under three years of age and over 17 years of age
  • Children older than six years who do not agree to the term of assent
  • Patients who have started antineoplastic treatment
  • Patients with syndromes and/or other systemic diseases associated with the diagnosis of lymphoid and acute myeloid leukemia
  • Neoplasms other than lymphoid leukemia or acute myeloid
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Paulo S Santos, PhD 55-1432358000 ext 8552 paulosss@fob.usp.br
Contact: Daniela R Honório, PhD 55143235-8223 danirios@usp.br

Locations
Layout table for location information
Brazil
Faculdade de Odontologia de Bauru, Universidade de São Paulo Recruiting
Bauru, São Paulo, Brazil, 17012-901
Contact: Paulo S Santos, PhD    55-32358000 ext 8552    paulosss@fob.usp.br   
Principal Investigator: Reyna A Quispe, McS         
Sponsors and Collaborators
Paulo Sergio da Silva Santos
Investigators
Layout table for investigator information
Principal Investigator: Reyna A Quispe, MsC Faculdade de Odontologia de Bauru, Universidade de São Paulo
Tracking Information
First Submitted Date June 3, 2020
First Posted Date July 20, 2021
Last Update Posted Date July 20, 2021
Actual Study Start Date September 1, 2019
Actual Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2021)
  • Evaluation of dental condition [ Time Frame: 5 minutes to 10 minutes ]
    Dental condition is going to be evaluated by dental caries index (dmft index) (WHO, 2013).
  • Evalulation of periodontal condition [ Time Frame: 10 minutes to 15 minutes ]
    The periodontal evaluation it is goning to be evaluated by and gingival index (LOE, 1964)
  • Evalulation of oral hygiene [ Time Frame: 10 minutes to 15 minutes ]
    Oral hygiene is going to be evaluated by simplified oral hygiene index (IHO-S).
  • To evaluate oral mucositis [ Time Frame: 5 minutes to 10 minutes ]
    the presence of oral mucositis will be evaluated through the graduation recommended by the World Health Organization (WHO) (WHO, 1979).
  • Evaluation of oral pain of oral mucositis [ Time Frame: 1 minutes to 2 minutes ]
    The oral pain because of the oral mucositis is going to be evaluated by Visual Analogue Scael of pain and it is gonig to be scaled by the Wong-Backer face scale which is from 0 to 10 pontuation, being 1 the minimium pain percivied and 10 de maximium pain percieved. This evaluation it is going to be make only in children with leukemia.
  • Saliva collection [ Time Frame: 15 minutes to 20 minutes ]
    The collection of the saliva is going to be made by an unstimulated technic. The minimum of 2 mL to maximum of 10 ml of saliva are going to be collected.
  • to evaluate the quality of life of children percieved by parents [ Time Frame: 10 to 15 minutes ]
    A Pediatric Quality of Life Inventory Version 4.0 questionaire is going to be answered by children parentes with the following five options: never = 0, almost never = 1, sometimes = 2, often = 3, and almost always = 4.
  • to evaluate the impact of oral condition on the quality of life percieved by the children [ Time Frame: 10 to 15 minutes ]
    A OHIP-14 (Oral Health Impact Profile) questionnaire (adapted for children) is going to be applied to children with 6 years old or children older than 6 years old. The questionaire is going to be answered with five options: never = 0, almost never =1 , sometimes = 2, often = 3, and almost always = 4 which is represented by a face scale.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Health Condition and Quality of Life in Children With Leukemia
Official Title Clinical-microbiological Study of Oral Health Condition and Quality of Life of Children/Adolescent With Acute Lymphoid Leukemia and Acute Myeloid
Brief Summary Among the different types of cancer that most affect children, leukemia is the principal. One of the main treatments for leukemia is chemotherapy. Among the most common side effects of chemotherapy are nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis. It is still necessary to establish which microorganisms are predominant in the oral microbiota of children with leukemia, which factors influence it, what is its relationship with oral mucositis and what is their impact in the quality of life. To better understand the risks of secondary infection, it is important to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that may negatively impact the quality of life, to expose the risk of death as well as raise hospital costs for the care of children with leukemia. Objective: To identify the clinical characteristics of the oral condition, types of microorganisms of the oral microbiota, and quality of life in children/adolescents with acute lymphoid leukemia and acute myeloid leukemia before and during antineoplastic treatment, and compare them with healthy children/adolescent individuals. Methodology: Longitudinal, case-control study, with a convenience sample. The study group, composed of children/adolescent individuals who have a definitive diagnosis of acute lymphoid leukemia or acute myeloid leukemia. The control group, non-syndromic children/adolescents, with no history of cancer, matched by age and gender. The clinical condition of the mouth will be evaluated by means of indexes: dental caries index (dmft index), gingival index (GA), and simplified oral hygiene index. The assessment of the quality of life through the ohip-14 and POS-version14 quality of life questionnaire and microbiological evaluation of saliva through MALDI-TOF analysis. Statistical analysis will be performed through relative risk for cohort study with more than three paired groups. Odds ratio, for the control group more than three controlled groups and Mcnemere, for comparison with the control group, for more than three paired groups.
Detailed Description

In children, non-communicable diseases such as cancer are increasing every year. It became a priority on the global child health agenda. Each year, there were an estimated 30.000 new cases of cancer in children/adolescent individuals. In Brazil, between 2018-2019, there were 12.500 new cases of cancer in children and adolescents up to 19 years of age. The mortality rate was 7.917 cases.

Among the types of cancer that most affect children, leukemia is the most prevalent. In 2018, there was a forecast of 437.033 new cases of leukemia with a mortality of 309.006 individuals around the world.

One of the main treatments for leukemia is chemotherapy, the side effects can affect different parts of the body that may present since the beginning of the treatment. Chemotherapy produces systemic toxicity resulting in anemia, leukopenia, and thrombocytopenia that is more intense in the treatment of oncohematological diseases when compared to solid tumors. Among the most common side effects of chemotherapy are included nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis.

Some studies reported that the intensity of oral mucositis, as well as the risk of sepsis from secondary infection in the mouth of individuals with cancer, they can be influenced by some specific microorganisms present in the oral cavity. Factors such as oral hygiene, presence of dental caries, and periodontal disease may be related to the type of microorganisms present in the oral cavity. There is a lack of studies about microbiota oral in leukemic children. Oral microbiota in children with leukemia is predominantly composed of gram-positive microorganisms such as Streptococus viridans, Streptococous mutans and Lactobacillus when compared to adults oral microbiota where gram-negatives microorganisms such as Klebsiella spp., E coli, Enterobacter, Pseudomonas spp. predominate. It is noteworthy that it is necessary to establish what kind of microorganisms are predominant in the oral microbiota of children with leukemia, also which factors influence it, and what is the relationship among the oral mucositis, general clinical status, and quality of life of the children/adolescent with cancer.

Therefore, it is important to identify the risks of secondary infection in oral cavity, to be able to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that can negatively impact the quality of life, expose the risk of death as well as raise hospital costs for the care of children with leukemia.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples With DNA
Description:
There are going to collect saliva for this study, which is going to be stored for 10 years as the maximum limit.
Sampling Method Non-Probability Sample
Study Population The study group will be composed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender.
Condition
  • Leukemia, Lymphoblastic
  • Leukemia, Myeloid, Acute
Intervention Other: This study is observational
  • Clinical evaluation of the oral health condition
  • Microbiota evaluation by analyzing the collected saliva
  • Application of questionnaires of quality of life
Study Groups/Cohorts
  • Study group
    Composed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender.
    Intervention: Other: This study is observational
  • Control group
    The control group is going to consist of healthy children/adolescent individuals, non-syndromic, without history of cancer, matched by age and gender in relation to the study group, who have not used antibiotics 48 hours before or in the day of evaluation.
    Intervention: Other: This study is observational
Publications *
  • Steliarova-Foucher E, Fidler MM, Colombet M, Lacour B, Kaatsch P, Piñeros M, Soerjomataram I, Bray F, Coebergh JW, Peris-Bonet R, Stiller CA; ACCIS contributors. Changing geographical patterns and trends in cancer incidence in children and adolescents in Europe, 1991-2010 (Automated Childhood Cancer Information System): a population-based study. Lancet Oncol. 2018 Sep;19(9):1159-1169. doi: 10.1016/S1470-2045(18)30423-6. Epub 2018 Aug 8.
  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313.
  • Carlotto A, Hogsett VL, Maiorini EM, Razulis JG, Sonis ST. The economic burden of toxicities associated with cancer treatment: review of the literature and analysis of nausea and vomiting, diarrhoea, oral mucositis and fatigue. Pharmacoeconomics. 2013 Sep;31(9):753-66. doi: 10.1007/s40273-013-0081-2. Review.
  • Özdemir ZC, Bozkurt Turhan A, Düzenli Kar Y, Dinleyici ÇE, Bör Ö. Fatal course of Saprochaete capitata fungemia in children with acute lymphoblastic leukemia. Pediatr Hematol Oncol. 2017 Mar;34(2):66-72. doi: 10.1080/08880018.2017.1316808. Epub 2017 Jun 2.
  • Damascena LCL, de Lucena NNN, Ribeiro ILA, de Araujo TLP, de Castro RD, Bonan PRF, Lima Neto EA, de Araújo Filho LM, Valença AMG. Factors Contributing to the Duration of Chemotherapy-Induced Severe Oral Mucositis in Oncopediatric Patients. Int J Environ Res Public Health. 2018 Jun 1;15(6). pii: E1153. doi: 10.3390/ijerph15061153.
  • Napeñas JJ, Brennan MT, Bahrani-Mougeot FK, Fox PC, Lockhart PB. Relationship between mucositis and changes in oral microflora during cancer chemotherapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jan;103(1):48-59. Epub 2006 Apr 21. Review.
  • Santos de Faria AB, Silva IH, de Godoy Almeida R, Silva SP, Carvalho AT, Leão JC. Seroprevalence of herpes virus associated with the presence and severity of oral mucositis in children diagnosed with acute lymphoid leukemia. J Oral Pathol Med. 2014 Apr;43(4):298-303. doi: 10.1111/jop.12138. Epub 2013 Dec 10.
  • O'Sullivan EA, Duggal MS, Bailey CC, Curzon ME, Hart P. Changes in the oral microflora during cytotoxic chemotherapy in children being treated for acute leukemia. Oral Surg Oral Med Oral Pathol. 1993 Aug;76(2):161-8.
  • Volpato LE, Kloster AP, Nunes LF, Pedro FL, Borges AH. Cariogenic microbiota of children under chemotherapy: A pilot study. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):370-6. doi: 10.4103/0970-4388.191423.
  • Valéra MC, Noirrit-Esclassan E, Pasquet M, Vaysse F. Oral complications and dental care in children with acute lymphoblastic leukaemia. J Oral Pathol Med. 2015 Aug;44(7):483-9. doi: 10.1111/jop.12266. Epub 2014 Sep 22. Review.
  • Wang Y, Xue J, Zhou X, You M, Du Q, Yang X, He J, Zou J, Cheng L, Li M, Li Y, Zhu Y, Li J, Shi W, Xu X. Oral microbiota distinguishes acute lymphoblastic leukemia pediatric hosts from healthy populations. PLoS One. 2014 Jul 15;9(7):e102116. doi: 10.1371/journal.pone.0102116. eCollection 2014. Erratum in: PLoS One. 2014;9(10):e110449. He, Jingzhi [corrected to He, Jinzhi].
  • Villafuerte KRV, Martinez CJH, Dantas FT, Carrara HHA, Dos Reis FJC, Palioto DB. The impact of chemotherapeutic treatment on the oral microbiota of patients with cancer: a systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol. 2018 Jun;125(6):552-566. doi: 10.1016/j.oooo.2018.02.008. Epub 2018 Feb 21. Review.
  • Bardellini E, Amadori F, Majorana A. Oral hygiene grade and quality of life in children with chemotherapy-related oral mucositis: a randomized study on the impact of a fluoride toothpaste with salivary enzymes, essential oils, proteins and colostrum extract versus a fluoride toothpaste without menthol. Int J Dent Hyg. 2016 Nov;14(4):314-319. doi: 10.1111/idh.12226. Epub 2016 May 10.
  • Grando LJ, Mello ALSF, Salvato L, Brancher AP, Del Moral JAG, Steffenello-Durigon G. Impact of leukemia and lymphoma chemotherapy on oral cavity and quality of life. Spec Care Dentist. 2015 Sep;35(5):236-242. doi: 10.1111/scd.12113. Epub 2015 May 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 8, 2021) 		3
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 17, 2022
Actual Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who, based on the agreement of parents and/or guardians, agree to participate in the research with a signed "Informed Consent Form"
  • Patients from 3 to 17 years of age
  • Patients older than 6 years must not only have parental and/or guardian authorization must have the consent term
  • Patients who have not started antineoplastic treatment
  • Patients with ALL only with BFM protocol
  • AML patients with BFM protocol only

Exclusion Criteria:

  • Responsible for patients who do not sign the free and informed consent form.
  • Patients under three years of age and over 17 years of age
  • Children older than six years who do not agree to the term of assent
  • Patients who have started antineoplastic treatment
  • Patients with syndromes and/or other systemic diseases associated with the diagnosis of lymphoid and acute myeloid leukemia
  • Neoplasms other than lymphoid leukemia or acute myeloid
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Paulo S Santos, PhD 55-1432358000 ext 8552 paulosss@fob.usp.br
Contact: Daniela R Honório, PhD 55143235-8223 danirios@usp.br
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT04968860
Other Study ID Numbers LEUKEMIARAQ
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Paulo Sergio da Silva Santos, University of Sao Paulo
Study Sponsor Paulo Sergio da Silva Santos
Collaborators Not Provided
Investigators
Principal Investigator: Reyna A Quispe, MsC Faculdade de Odontologia de Bauru, Universidade de São Paulo
PRS Account University of Sao Paulo
Verification Date July 2021