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 |
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Intrabony Periodontal Defect | Procedure: Titanium Granules Procedure: Hydroxyapatite | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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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.
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Procedure: Titanium Granules
After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.
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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.
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Procedure: Hydroxyapatite
After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
Contact: R V Chandra, MDS;DNB;PhD | 9908183071 | viswachandra@hotmail.com |
India | |
SVS Institute of Dental Sciences, Mahabubnagar | Recruiting |
Hyderabad, Telangana, India, 509002 | |
Contact: Rampalli V Chandra, MDS; DNB 9908183071 viswachandra@hotmail.com |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Intrabony Periodontal Defect | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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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 |
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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 |