A Closed Surgical Technique vs Papilla Preservation Techniques

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Procedure: Access Flap; Procedure: Closed Surgical Technique

• Registration Number: NCT05754307
• Lead Sponsor: Danae A. Apatzidou

Brief Summary

A pioneer periodontal surgical approach employing the closed surgical technique (CST) has been designed to gain access to isolated interdental periodontal defects and retain the soft-tissue architecture. This technique is based on a modified tunnelling technique to retract full-thickness gingival flaps from the osseous defect in a closed manner retaining intact the interproximal papilla thus, suturing is not required. A randomised controlled clinical trial will determine the efficacy of the CST versus the access flap employing papilla preservation techniques over a period of 6 months.

Detailed Description

This randomised controlled clinical trial will compare the CST over the access flap employing papilla preservation techniques to treat isolated interdental defects in terms of gain in clinical attachment levels, radiographic evidence of bone apposition and local reduction of pro-inflammatory cytokines over a period of 6 months.

1. First visit - initial examination - at least 3 months after initial non-surgical periodontal treatment (Step 1, 2) Update general and dental history Screening of subjects for suitability; Consent form; Randomization of suitable subjects Intra-oral photography Full-mouth charting: Probing pocket depth (PPD), Clinical Attachment Level (CAL), Plaque Index (PI), Bleeding on Probing (BoP), Gingival Recession (Rec) Oral hygiene instructions (soft toothbrush, modified Bass, interdental cleaning) Full mouth supragingival scaling

2. Second visit - Baseline - T0 Collection of Gingival Crevice Fluid (GCF) using sterilized paper strips Radiographic examination of the site (Long-cone paralleling technique using a digital sensor attached to a custom-made silicone bite block for reproducible radiographs) Periodontal site-selected clinical assessment Periodontal surgery (control: access flap with papilla preservation techniques or test: the CST) under local anaesthesia Modification of oral hygiene instructions; post-operative instructions Intra-oral photography

3. Third visit - T1 (2 weeks post-operatively) Suture removal (only in control group) Wound healing visual monitoring by the Early Healing Index (1-5) Oral hygiene instructions Intra-oral photography Questionnaire for subjective feelings and satisfaction

4. Fourth visit - T2 (6 weeks post-operatively) Oral hygiene instructions Intra-oral photography

5. Fifth visit - T3 - Re-evaluation (6 months post-operatively) GCF collection using sterilized paper strips Periodontal full-mouth charting Site-selected periodontal clinical assessment; Probing Pocket depth (PPD), Clinical Attachment Level (CAL), Plaque Index (PI), Bleeding on Probing (BoP), Gingival Recession (Rec Radiographic examination of the site Oral hygiene instructions Intra-oral photography

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study Start: 2023-03-03
• Study First Posted: 2023-03-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Systematically healthy subjects, not having consumed antibiotics 3 months before surgical periodontal treatment (baseline)
• Smokers <5 cig/day, former smokers or no smokers
• Periodontal patients fulfilling non surgical initial periodontal treatment at least 3 months before surgical periodontal treatment (baseline day) and presenting at least one residual pocket with PPD and CAL ≥6mm and bleeding on probing, located interproximally with intrerdental site ≥2mm.
• Compliant patients presenting high standards of oral hygiene (full mouth Plaque Index <20%) strictly susceptible in Supportive Periodontal Treatment

Exclusion Criteria

• Untreated active periodontal inflammation
• Poorly controlled systematic diseases
• Disorders compromise wound healing
• Bisphosphonate medications
• Patients under radiotherapy or chemotherapy
• Drug-indused gingival hyperplasia
• Pregnancy or lactation
• Poor compliance during steps 1 and 2 of cause-related periodontal treatment
• Compromised oral hygiene (full mouth Plaque Index >30%), circumferential bone defect or narrow intrerdental site ≤2mm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control surgical technique	Access Flap	Intrasulcular incisions at the teeth adjacent to the defect, using the simplified papilla preservation technique (SPPT) or modified papilla preservation technique (MPPT). Granulation tissue is excised and debridement via hand and power-driven instruments follows. Flaps are repositioned and papilla are sutured with horizontal internal mattress doubled by a single interrupted interdental suture.
Test surgical technique	Closed Surgical Technique	Strictly intrasulcular incisions are performed at the teeth adjacent to the defect (mid-buccal to mid-lingual) without incising the interdental papilla. Full thickness gingival flaps, at the base of the papilla, which is retained intact, are elevated in a "closed"-tunneling manner, granting access to the interdental osseous defect. Debridement is performed via power-driven tips and mini curettes, without intentional excising the granulation tissue that lines the osseous defect. Flaps are repositioned by gentle pressure and suturing is not required.

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	baseline to 6 months	Determined by a manual periodontal probe(Hu-Friedy XP-23/QW) by a single examiner at the nearest of 1mm
Cementoenamel junction to Bottom of the defect	baseline to 6 months	Determined on standardised periapical radiographs obtained by the long cone parallel technique

Secondary Outcome Measures

Name	Time	Method
Probing Pocket Depth	baseline to 6 months	Determined by a manual periodontal probe
Recession	baseline to 6 months	Determined by a manual periodontal probe
Levels of proinflammatory cytokines	baseline to 6 months	Determined by ELISA in GCF
Bleeding on Probing	baseline to 6 months	Determined by a manual periodontal probe
Patient satisfaction and perception	2 weeks following surery	Determined on questionnaires

Trial Locations

Locations (1)

Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology; 🇬🇷 Thessaloniki, Greece