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

NCT06204588 | Recruiting DMC

• 1 other identifier: Shikha IMRG Perio
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Clinical attachment level

  Periodontal probe will be used to measure clinical attachment level

  24 months

• alveolar bone level

  transgingival probing using periodontal probe and by radiographically using CBCT

  24 months

Study Arms (3)

Test group-1

EXPERIMENTAL

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

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

Test group-2

EXPERIMENTAL

Single flap approach along with diode laser (SFA+LLLT).

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

Control group

EXPERIMENTAL

using single flap approach only

Procedure: control group: SFA only

Interventions

control group: SFA only PROCEDURE

Single flap approach

Control group

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

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

Test group-1

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

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

Test group-2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Periodontitis stage 2 and stage 3 patients will be enrolled according to criteria of 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
• Horizontal bone loss defects with depth ≥ 5 mm (initially analyzed by trans-gingival probing and intraoral periapical radiographs and will be confirmed further after flap elevation and CBCT)
• PPD ≥ 5 mm
• CAL ≥ 3 mm
• Tooth mobility \< grade 1
• Experimental teeth and adjacent teeth would be required to be vital and free of caries or dental restorations

You may not qualify if:

• Any systemic illness that could affect the periodontium or outcome of periodontal therapy
• patients on medications such as corticosteroids or calcium channel blockers
• long-term nonsteroidal anti-inflammatory drug therapy
• pregnant or lactating women
• current and past smoker
• Periodontitis stage 4
• teeth with one-wall defect, the presence of exostoses and ledges, grade II and grade III mobile teeth, defects extending to a root furcation area, unrestorable teeth, fractured/perforated roots, developing permanent teeth, endodontically treated teeth, and teeth with premature contact and dental prosthesis.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Shikha Tewari

  Post graduate institute of Dental Sciences ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tewari Sanjay

CONTACT

01262; principalpgids@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 12, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)