Entire Papilla Preservation and Conventional Flap Surgery in Treating Intrabony Defects: A 6-Month Clinical Trial

Active, not recruiting

• Conditions: Periodontal Intrabony Defect

• Registration Number: NCT06687785
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

Intraosseous defects are characterized by vertical bone loss within the borders of the alveolar bone surrounding the teeth due to periodontal disease and are considered a clinically concerning condition. Treatment of intraosseous defects involves regenerative techniques aimed at reconstructing lost periodontal structures (including bone, cementum and periodontal ligament). In the process of periodontal regeneration, it is of great importance that the blood clot attached to the root surface is protected from mechanical and microbiological factors and remains in a stable biological environment. Post-surgical wound dehiscence can lead to impaired clot stabilization and infection, negatively affecting the healing process and thus jeopardizing the results of the treatment.

Regenerative therapies using conventional flap surgery have been reported to provide significant improvements in clinical attachment levels, but carry a high risk of loss of attachment if flap management is inadequate. Furthermore, complications such as difficulty in primary closure, risk of membrane exposure and tissue detachment have been observed with conventional flap techniques. Various minimally invasive flap surgery techniques have been developed to prevent these complications. One of the minimally invasive periodontal flap techniques is the full papillary preservation technique. Unlike traditional methods, this innovative approach provides vertical access to the defect area from the buccal and lingual adjacent areas without any incision in the papillary region. This technique reduces the risk of wound healing failure and exposure of regenerative biomaterials due to the fully preserved interdental papilla over the bony defect. The aim of our study is to compare the short-term (6 months) radiographic and clinical results of the Entire Papilla Preservation (EPP) technique with the Conventional Flap Surgery (CFS) technique.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-26
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-14
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Systemic health
• Probing depth (PD) ≥7 mm
• Clinical attachment level (CAL) ≥7 mm
• Presence of an isolated two or three walled intraosseous defect with an intraosseous component of at least 4 mm predominantly involving the interproximal region of the affected tooth
• Full mouth plaque score (FMPS) and full mouth bleeding score ≤20%

Exclusion Criteria

• Current smoking habit
• Presence of uncontrolled systemic diseases that prevent periodontal surgery
• Use of drugs that affect periodontal tissues
• Pregnancy and breastfeeding
• Single-walled intraosseous defects
• Defects involving the buccal and/or lingual areas of the tooth
• Inadequate endodontic treatment and/or restorations on teeth in the defect area.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probing Depth	6 MONTH	Probing Depth (PD) refers to the distance from the gingival margin to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value.
Clinical Attachment Level	6 MONTH	Clinical Attachment Level (CAL) is defined as the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value.
Gingival Recession	6 MONTH	Gingival Recession (GR) refers to the apical migration of the gingival margin, resulting in exposure of the root surface. While it should be 0 in healthy individuals, an increase is a bad value.

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale	for 2 weeks after treatment	Postoperative patients were asked to fill out a visual analogue scale to determine their pain levels on the 1st, 3rd, 7th and 14th days. This scale was scored between 0-100, with 0 indicating no pain and 100 indicating unbearable pain.
Early healing index.	1 week after treatment	The healing status in the first postoperative week was evaluated with a score between 1(perfect healing) and 5(worst healing) using the early healing index.

Trial Locations

Locations (1)

Necmettin Erbakan University, Faculty of Dentistry; 🇹🇷 Konya, Turkey