Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- periodontal surgery
- Conditions
- Periodontal Pocket
- Sponsor
- Universidad de Murcia
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Clinical attachment gain (CAG)
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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).
Investigators
Antonio José Ortiz Ruiz, MD
Professor and researcher
Universidad de Murcia
Eligibility Criteria
Inclusion Criteria
- •Stage III or IV periodontitis, including all grades.
- •Unresolved deep pockets (probing pocket depth \[PPD\] \>5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
- •Interproximal plaque index \<35% maintained during periodontal treatment and maintenance.
- •Adherence to periodontal maintenance appointments.
Exclusion Criteria
- •Systemic disease contraindicating periodontal surgery.
- •Teeth with incorrect endodontic treatment or restoration.
- •Stage I or II periodontitis.
Arms & Interventions
Control
Access flap periodontal surgery
Intervention: periodontal surgery
Test
Access flap periodontal surgery and periodontal granulation tissue debridement.
Intervention: periodontal surgery
Outcomes
Primary Outcomes
Clinical attachment gain (CAG)
Time Frame: 12 months
Clinical attachment gain
Secondary Outcomes
- PPDr(12 months)
- SUPRA-AG(12 months)
- rPD(12 months)
- iGR(12 months)
- Early Healing Index (EHI)(1 week)