Evaluating bone regeneration in patients with horizontal bone loss using collagen and 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

This study is testing if a special collagen treatment combined with laser therapy can help people with gum disease and bone loss grow back their bone better than standard surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak (other)
• Locations: 1 site (Rohtak, Haryana)
• Trial ID: NCT06204588 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of a volume stable collagen matrix (VCMX) combined with low-level laser therapy (LLLT) in regenerating bone in patients suffering from horizontal bone loss due to periodontitis. Participants will be divided into groups receiving different treatment combinations, including VCMX with LLLT and a control group receiving standard flap surgery. The study will evaluate the regeneration of supracrestal bone and the overall success of these treatment modalities in improving periodontal health. The trial will include patients with specific criteria related to their periodontal condition and bone loss severity.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with stage 2 or stage 3 periodontitis and horizontal bone loss defects measuring 5 mm or more.

Not a fit: Patients with systemic illnesses affecting periodontal health, those on certain medications, or with advanced periodontitis (stage 4) are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve bone regeneration in patients with horizontal bone loss, leading to better periodontal health and reduced tooth loss.

How similar studies have performed: While there is limited success recorded for similar approaches, this study aims to explore a novel combination of therapies that have not been extensively tested together.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Rohtak, Haryana

• Post Graduate Institute of Dental Sciences — Rohtak, Haryana, India (RECRUITING)

Study contacts

• Principal investigator: Shikha Tewari — Post graduate institute of Dental Sciences ROHTAK
• Study coordinator: Tewari Sanjay

Conditions: Bone Loss, Alveolar