Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

NCT04932161 | Unknown

• 1 other identifier: SVSIDS/PERIO/4/2020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect

Keywords

Intrabony defects; Titanium Granules

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Plaque Index

  from baseline to 6 months

• Gingivitis

  from baseline to 6 months

Study Arms (2)

Titanium Granules as a bone graft in intrabony defects

EXPERIMENTAL

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

Hydroxyapatite as a bone graft in intrabony defects

ACTIVE COMPARATOR

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

Interventions

Titanium Granules PROCEDURE

After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.

Titanium Granules as a bone graft in intrabony defects

Hydroxyapatite PROCEDURE

After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.

Hydroxyapatite as a bone graft in intrabony defects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Telangana, 509002, India

RECRUITING

MeSH Terms

Interventions

Durapatite

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Central Study Contacts

R V Chandra, MDS;DNB;PhD

CONTACT

9908183071; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 21, 2021
• Study Start: August 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

IN (1)