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Evaluation of Regenerative Potential in Horizontal Bone Loss Using VCMX Along With LASER Therapy

NCT06204588 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-17

No results posted yet for this study

Summary

Background- Periodontitis, an inflammatory disease of the periodontium, is one of the major causes of tooth mortality. Of all the bone destruction patterns that are present in periodontitis, horizontal bone loss is the most common. Therefore, treatment modalities that help in rebuilding horizontal defects are vital in total periodontal reconstruction.

Rationale- The supracrestal bone regeneration in cases of horizontal bone loss has remained a mirage with very little recorded success. Volume stable collagen matrix(VCMX), is a porous, cross-linked collagen matrix of porcine origin designed to facilitate cell and vascular ingrowth and soft-tissue volume augmentation, may be beneficial in maintaining the supracrestal space and may overcome the limitation of bone regeneration in horizontal defects. Evidence has shown that Low level laser therapy(LLLT) based on principal of biostimulation of osteoclastic cells, can have a positive effect on the regeneration of supracrestal bone in horizontal bone destruction. So, this study will be first of its kind using combination of VCMX with LLLT to assess regenerative outcome in treatment of horizontal bone destruction in patients with periodontitis.

Objectives: To assess clinical and radiographic regenerative outcome of periodontal tissues using LLLT and placing VCMX with single flap approach(SFA) in treatment of horizontal bone loss as compared to LLLT and SFA.

Method: A total of 60 patients will be randomly divided into three groups: Test Group 1: VCMX +LLLT +SFA, Test Group 2:LLLT+SFA, and Control group: SFA. Periodontal parameters will be evaluated at baseline, 3, 6, and 9 months. CBCT will be evaluated at baseline and 9 months.

Expected outcome: VCMX with Laser could achieve supracrestal bone regeneration in horizontal bone loss.

Conditions

  • Bone Loss, Alveolar

Interventions

PROCEDURE

control group: SFA only

Single flap approach

PROCEDURE

Test group 1: VCMX + Low level LASER therapy + Single flap approach

using collagen matrix and laser therapy in horizontal bone loss defects by single flap approach (SFA+VCMX+LLLT).

PROCEDURE

Test group 2: Low level LASER therapy + Single flap approach

Laser therapy in horizontal bone loss defects by single flap approach (SFA+LLLT).

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

  • Shikha Tewari · Post graduate institute of Dental Sciences ROHTAK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204588 on ClinicalTrials.gov