Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique

Launched by UNIVERSITY OF TURIN, ITALY · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of surgeries to treat patients with severe gum disease, known as stage III-IV periodontitis. The study aims to compare a specific type of surgery that removes bone around the teeth (called fibre retention osseous resective surgery, or FibReORS) with a more conservative surgical approach, which may or may not include a technique to preserve the gum tissue between teeth (called papilla preservation technique, or PPT). The researchers will track how effective each surgery is in reducing deep pockets around the teeth (spaces where bacteria can grow), as well as other important outcomes, over a period of 1, 3, and 5 years.

To be eligible for this trial, participants need to have been diagnosed with severe gum disease and completed initial treatments at least six weeks prior. They should also have specific conditions, like having certain deep pockets around their teeth, while meeting other health criteria. Participants will be monitored closely throughout the study, and their experiences will help researchers understand which surgical approach might lead to better long-term outcomes for patients with this condition. It’s important to note that the trial is not yet recruiting participants, and there are specific health conditions that may prevent someone from joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of stage III/IV periodontitis.
• • Completed steps I-II periodontal therapy at least 6 weeks before.
• • Full Mouth Plaque Score less than 15% at re-evaluation.
• • Full Mouth Bleeding Score less than 15% at re-evaluation.
• • Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
• • Signed informed consent.
• Exclusion Criteria:
• • Compromised general health which contraindicates the study procedures (ASA III-VI patients).
• • Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
• • Pregnant or nursing women.
• • Presence of tooth mobility ≥ class 2.
• • Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
• • Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.