Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

Sponsor
SVS Institute of Dental Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04932161
Collaborator
(none)
12
1
2
16
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Titanium Granules
  • Procedure: Hydroxyapatite
N/A

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
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparative Efficacy of Titanium Granules Over Hydroxyapatite in the Treatment of Periodontal Intrabony Defects: A Clinico-radiographic Study
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Titanium Granules as a bone graft in intrabony defects

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

Active Comparator: Hydroxyapatite as a bone graft in intrabony defects

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. Plaque Index [from baseline to 6 months]

    Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.

  2. Gingivitis [from baseline to 6 months]

    Assessment of Gingivitis (GI) - according to Loe H and Silness P, 1963.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 SVS Institute of Dental Sciences, Mahabubnagar Hyderabad Telangana India 509002

Sponsors and Collaborators

  • SVS Institute of Dental Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr R Viswa Chandra, Primary Investigator, SVS Institute of Dental Sciences
ClinicalTrials.gov Identifier:
NCT04932161
Other Study ID Numbers:
  • SVSIDS/PERIO/4/2020
First Posted:
Jun 21, 2021
Last Update Posted:
Jun 21, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr R Viswa Chandra, Primary Investigator, SVS Institute of Dental Sciences

Study Results

No Results Posted as of Jun 21, 2021