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Clinical Trials/NCT04932161
NCT04932161UnknownNot Applicable

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

SVS Institute of Dental Sciences1 site in 1 country12 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
12
Locations
1
Primary Endpoint
Probing Depth

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

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.

Intervention: Titanium Granules (Procedure)

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.

Intervention: Hydroxyapatite (Procedure)

Outcomes

Primary Outcomes

Probing Depth

Time Frame: 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.

Bone Regeneration

Time Frame: 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

Time Frame: from baseline to 6 months

Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.

Secondary Outcomes

  • Gingivitis(from baseline to 6 months)
  • Plaque Index(from baseline to 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr R Viswa Chandra

Primary Investigator

SVS Institute of Dental Sciences

Study Sites (1)

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