4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

Study Description
Brief Summary:

The ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD).

Titanium stimulates activation of the complement system, surface binding of platelets, and platelet activation as reflected by increased levels of platelet-derived growth factor, which is a substantial promoter of bone growth. Hence we may speculate that using a bone substitute made of titanium may be positive from the perspective of bone formation in osseous defects.


Condition or disease Intervention/treatment Phase
Intrabony Periodontal Defect Procedure: Titanium Granules Procedure: Hydroxyapatite Not Applicable

Detailed Description:

Titanium granules consist of irregular porous granules of commercially pure titanium. The porous properties may lead to ingrowth of newly formed bone.The osseointegrating response to titanium may be the result of the potent activation of the intrinsic coagulation system and the subsequent release of growth factors from platelets.Therefore, the aim of this study is to compare the effect of titanium particles and hydroxyapatite on osseous regeneration in intrabony defects.

After reflection of flap and degranulation, bone graft i.e., titanium particles (test group) or hydroxyapatite(control group) will be placed in the void created by the defect and sutures will be placed.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Titanium Granules as a bone graft in intrabony defects
In test group, after reflection of flap and degranulation, bone graft i.e., titanium particles will be placed in the void created by the defect and sutures will be placed.
Procedure: Titanium Granules
After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.

Active Comparator: Hydroxyapatite as a bone graft in intrabony defects
In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed.
Procedure: Hydroxyapatite
After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.

Outcome Measures
Primary Outcome Measures :
  1. Clinical Attachment Level [ Time Frame: from baseline to 6 months ]
    Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.

  2. Probing Depth [ Time Frame: from baseline to 6 months ]
    Assessment of probing depth using University of North Carolina(UNC)-15 probe at baseline and postoperatively at 3 and 6 months.

  3. Bone Regeneration [ Time Frame: at 3 months and 6 months ]
    Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.


Secondary Outcome Measures :
  1. Plaque Index [ Time Frame: from baseline to 6 months ]
    Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.

  2. Gingivitis [ Time Frame: from baseline to 6 months ]
    Assessment of Gingivitis (GI) - according to Loe H and Silness P, 1963.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Systemically healthy male and female patients of age >18 years with two-walled or three-walled intrabony defects and probing pocket depths (PPD) of >3mm.

Exclusion Criteria:

Medically compromised patients, patients <18 years of age, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy are excluded.

Contacts and Locations

Contacts
Layout table for location contacts
Contact: R V Chandra, MDS;DNB;PhD 9908183071 viswachandra@hotmail.com

Locations
Layout table for location information
India
SVS Institute of Dental Sciences, Mahabubnagar Recruiting
Hyderabad, Telangana, India, 509002
Contact: Rampalli V Chandra, MDS; DNB    9908183071    viswachandra@hotmail.com   
Sponsors and Collaborators
SVS Institute of Dental Sciences
Tracking Information
First Submitted Date  ICMJE June 17, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date June 21, 2021
Estimated Study Start Date  ICMJE August 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
  • Clinical Attachment Level [ Time Frame: from baseline to 6 months ]
    Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.
  • Probing Depth [ Time Frame: from baseline to 6 months ]
    Assessment of probing depth using University of North Carolina(UNC)-15 probe at baseline and postoperatively at 3 and 6 months.
  • Bone Regeneration [ Time Frame: at 3 months and 6 months ]
    Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
  • Plaque Index [ Time Frame: from baseline to 6 months ]
    Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.
  • Gingivitis [ Time Frame: from baseline to 6 months ]
    Assessment of Gingivitis (GI) - according to Loe H and Silness P, 1963.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects
Official Title  ICMJE Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study
Brief Summary

The ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD).

Titanium stimulates activation of the complement system, surface binding of platelets, and platelet activation as reflected by increased levels of platelet-derived growth factor, which is a substantial promoter of bone growth. Hence we may speculate that using a bone substitute made of titanium may be positive from the perspective of bone formation in osseous defects.

Detailed Description

Titanium granules consist of irregular porous granules of commercially pure titanium. The porous properties may lead to ingrowth of newly formed bone.The osseointegrating response to titanium may be the result of the potent activation of the intrinsic coagulation system and the subsequent release of growth factors from platelets.Therefore, the aim of this study is to compare the effect of titanium particles and hydroxyapatite on osseous regeneration in intrabony defects.

After reflection of flap and degranulation, bone graft i.e., titanium particles (test group) or hydroxyapatite(control group) will be placed in the void created by the defect and sutures will be placed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Intrabony Periodontal Defect
Intervention  ICMJE
  • Procedure: Titanium Granules
    After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.
  • Procedure: Hydroxyapatite
    After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.
Study Arms  ICMJE
  • Experimental: Titanium Granules as a bone graft in intrabony defects
    In test group, after reflection of flap and degranulation, bone graft i.e., titanium particles will be placed in the void created by the defect and sutures will be placed.
    Intervention: Procedure: Titanium Granules
  • Active Comparator: Hydroxyapatite as a bone graft in intrabony defects
    In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed.
    Intervention: Procedure: Hydroxyapatite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2021)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Systemically healthy male and female patients of age >18 years with two-walled or three-walled intrabony defects and probing pocket depths (PPD) of >3mm.

Exclusion Criteria:

Medically compromised patients, patients <18 years of age, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy are excluded.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: R V Chandra, MDS;DNB;PhD 9908183071 viswachandra@hotmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04932161
Other Study ID Numbers  ICMJE SVSIDS/PERIO/4/2020
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  ICMJE Not Provided
Responsible Party Dr R Viswa Chandra, SVS Institute of Dental Sciences
Study Sponsor  ICMJE SVS Institute of Dental Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SVS Institute of Dental Sciences
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP