Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

Study Overview
=================
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.

Official Title
-----------------
Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study

Conditions
-----------------
Intrabony Periodontal Defect

Intervention / Treatment
-----------------
* Procedure: Titanium Granules
* Procedure: Hydroxyapatite


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Titanium Granules as a bone graft in intrabony defects<br>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<br>* After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.<br>|
| Active Comparator: Hydroxyapatite as a bone graft in intrabony defects<br>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<br>* After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Level | Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months. | from baseline to 6 months | 
| Probing Depth | Assessment of probing depth using University of North Carolina(UNC)-15 probe at baseline and postoperatively at 3 and 6 months. | from baseline to 6 months | 
| Bone Regeneration | Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months. | at 3 months and 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrabony defects, Titanium Granules