Clinical trial NCT06687785: Entire Papilla Preservation and Conventional Flap Surgery in Treating Intrabony Defects: A 6-Month Clinical Trial
Official title: A Comparison of the Clinical and Radiographic Results of the Entire Papilla Preservation (EPP) Technique and Conventional Flap Surgery (CFS) Technique in the Treatment of Isolated Intrabony Defects at 6 Months
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Periodontal Intrabony Defect
Keywords: intrabony defect
conventional flap surgery
bone graft
entire papilla preservation
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Periodontitis patients with isolated intrabony defects

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Probing Depth
timeFrame: 6 MONTH
measure: Clinical Attachment Level
timeFrame: 6 MONTH
measure: Gingival Recession
timeFrame: 6 MONTH
Secondary outcomes:
measure: Visual analogue scale
timeFrame: for 2 weeks after treatment
measure: Early healing index.
timeFrame: 1 week after treatment
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Faculty of Dentistry
Study officials:
affiliation: Necmettin Erbakan University
name: Fatma UCAN YARKAC, assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stavropoulos A, Karring T. Five-year results of guided tissue regeneration in combination with deproteinized bovine bone (Bio-Oss) in the treatment of intrabony periodontal defects: a case series report. Clin Oral Investig. 2005 Dec;9(4):271-7. doi: 10.1007/s00784-005-0002-7. Epub 2005 Jul 12.
citation: Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584.