RecruitingNot ApplicableNCT05533528

Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial

Sponsor

Universidad de Murcia

Enrollment

25 participants

Start Date

May 3, 2022

Study Type

INTERVENTIONAL

Conditions

Periodontal Diseases Periodontal Pocket Periodontal Bone Loss

Summary

The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential. The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue). Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to periodontal (gum) surgery — one that preserves granulation tissue (tissue that forms in infected pockets) and one that removes it — in patients with severe gum disease who still have deep pockets after initial non-surgical treatment. The goal is to see whether keeping this tissue improves healing outcomes. You may be eligible if... - You have been diagnosed with Stage III or Stage IV periodontitis (severe gum disease) - You still have deep gum pockets (probing depth greater than 5 mm with bleeding) 4 to 6 weeks after initial non-surgical treatment - You have maintained good oral hygiene (plaque index below 35%) during treatment - You are keeping up with your periodontal maintenance appointments You may NOT be eligible if... - You have a systemic medical condition that prevents periodontal surgery - The affected teeth have incorrect root canal treatment or restorations - You have Stage I or Stage II (milder) periodontitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREperiodontal surgery

A sulcular incision will be made in the affected teeth, followed by an incision from the buccal aspect in the mid-portion of the interproximal tissues The buccal and lingual flaps will be elevated. For periodontal granulation tissue preservation group, the soft tissues covering the alveolar crest will be prepared. A third incision will separate the pocket epithelium from the soft tissue (granulation tissue) attached to the bone. The pocket epithelium will be removed. The root surfaces will be carefully scaled and planed in both groups. Ethylenediaminetetraacetic acid (24%) will be applied to the root surfaces and removed after 2 minutes with abundant saline solution. In the experimental group, the preserved attached soft tissue and the space between it and the root surface will be irrigated with 10% polyvinylpyrrolidone-iodine. Finally, the flaps will be positioned and sutured.