Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

Intrabony Periodontal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932161
• Other study ID #: SVSIDS/PERIO/4/2020
• Status: Recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: December 2022

Study information

• Verified date: June 2021
• Source: SVS Institute of Dental Sciences
• Contact: R V Chandra, MDS;DNB;PhD
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intrabony Periodontal Defect

Intervention

Procedure:
• Titanium Granules
After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.
• Hydroxyapatite
After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.

Locations

Country	Name	City	State
India	SVS Institute of Dental Sciences, Mahabubnagar	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Plaque Index	Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.	from baseline to 6 months
Secondary	Gingivitis	Assessment of Gingivitis (GI) - according to Loe H and Silness P, 1963.	from baseline to 6 months