Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

Not Applicable

• Conditions: Intrabony Periodontal Defect
• Interventions: Procedure: Titanium Granules; Procedure: Hydroxyapatite

• Registration Number: NCT04932161
• Lead Sponsor: SVS Institute of Dental Sciences

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 Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21
• Study Start: 2021-08
• Primary Completion: 2022-02
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Titanium Granules as a bone graft in intrabony defects	Titanium Granules	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.
Hydroxyapatite as a bone graft in intrabony defects	Hydroxyapatite	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.

Primary Outcome Measures

Name	Time	Method
Bone Regeneration	at 3 months and 6 months	Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
Clinical Attachment Level	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	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.

Secondary Outcome Measures

Name	Time	Method
Gingivitis	from baseline to 6 months	Assessment of Gingivitis (GI) - according to Loe H and Silness P, 1963.
Plaque Index	from baseline to 6 months	Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.

Trial Locations

Locations (1)

SVS Institute of Dental Sciences, Mahabubnagar; 🇮🇳 Hyderabad, Telangana, India