Evaluation of Regenerative Potential in Horizontal Bone Loss Using VCMX Along With LASER Therapy
Clinical and Radiographic Evaluation of Volume Stable Collagen Matrix (VCMX) in the Regenerative Outcome of Periodontal Horizontal Bone Loss When Used With Diode Laser Therapy in Humans: A Randomized Controlled Clinical Trial
Postgraduate Institute of Dental Sciences Rohtak
60 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria7
- 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.
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Interventions
Single flap approach
using collagen matrix and laser therapy in horizontal bone loss defects by single flap approach (SFA+VCMX+LLLT).
Laser therapy in horizontal bone loss defects by single flap approach (SFA+LLLT).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06204588