Actively Recruiting
Evaluation of Regenerative Potential in Horizontal Bone Loss Using VCMX Along With LASER Therapy
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2024-05-17
60
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Regenerative Potential in Horizontal Bone Loss Using VCMX Along With LASER Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage 2 or stage 3 periodontitis as defined by the 2017 World Workshop
- Horizontal bone loss defects with depth of 5 mm or greater confirmed by probing and imaging
- Probing pocket depth of 5 mm or more
- Clinical attachment loss of 3 mm or more
- Tooth mobility less than grade 1
- Experimental and adjacent teeth must be vital and free of cavities or dental restorations
You will not qualify if you...
- Presence of systemic illnesses affecting periodontium or periodontal therapy outcomes
- Use of medications like corticosteroids or calcium channel blockers
- Long-term use of nonsteroidal anti-inflammatory drugs
- Pregnant or breastfeeding women
- Current or past smokers
- Patients with stage 4 periodontitis
- Teeth with one-wall defects, exostoses, ledges, grade II/III mobility, furcation defects, unrestorable or fractured roots, developing permanent teeth, endodontically treated teeth, premature contact, or dental prostheses
AI-Screening
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Trial Site Locations
Total: 1 location
1
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
T
Tewari Sanjay
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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