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

NCT06687785 | Active Not Recruiting

• 1 other identifier: 20576
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Intrabony Defect

Keywords

intrabony defect; conventional flap surgery; bone graft; entire papilla preservation

Outcome Measures

Primary Outcomes (3)

• Probing Depth

  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.

  6 MONTH

• Clinical Attachment Level

  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.

  6 MONTH

• Gingival Recession

  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.

  6 MONTH

Secondary Outcomes (2)

• Visual analogue scale

  for 2 weeks after treatment

• Early healing index.

  1 week after treatment

Study Arms (2)

Entire Papilla Preservation Technique

The Entire Papilla Preservation Technique (EPP) is a novel surgical approach aimed at enhancing periodontal regeneration, particularly in the treatment of deep intrabony defects. This technique is characterized by its focus on preserving the entire interdental papilla, which is crucial for both functional and aesthetic outcomes in periodontal therapy. The EPP technique involves creating a tunnel-like undermining incision that allows access to the defect while maintaining the integrity of the papilla, thereby minimizing trauma to the surrounding soft tissues

Procedure: Entire Papilla Preservation Technique

Conventional Flap Surgery

In periodontology, the traditional flap surgery technique is a well-established surgical approach used for the treatment of periodontal diseases, especially in cases with deep periodontal pockets. This technique involves the lifting of a mucoperiosteal flap in the buccal and lingual direction to gain access to the underlying periodontal tissues and allows for thorough debridement of root surfaces and removal of diseased tissue.

Procedure: Conventional Flap Surgery Technique

Interventions

Entire Papilla Preservation Technique PROCEDURE

A buccal intrasulcular incision was made in the tooth with the defect and a vertical incision was made extending from the buccal center of the tooth to the mesial papillary crest and crossing the mucogingival line. Then, using a micro periosteal elevator, a full-thickness mucoperiosteal flap was lifted from the incision site to the defect under the papilla. After removal of the granulation tissues in the area, bone graft was applied for regenerative purposes and the vertical incision was sutured with 6/0 polypropylene suture using simple suture technique.

Also known as: EPP

Entire Papilla Preservation Technique

Conventional Flap Surgery Technique PROCEDURE

After buccal and lingual intrasulcular incisions were made to eliminate the teeth and papillae adjacent to the defect, a full-thickness mucoperiosteal flap was raised in the vestibular and lingual direction with a periosteal elevator. After removal of the granulation tissues in the area, bone graft was applied for regenerative purposes and the papillary incisions were sutured with 5/0 polypropylene suture using simple suture technique.

Also known as: CFS

Conventional Flap Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Periodontitis patients with isolated intrabony defects

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Dentistry

Konya, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 16010581 RESULT

• 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.

  PMID: 28196163 RESULT

• Yarkac FU, Yildiz K, Kalender ME, Ogutcen O. Clinical and radiographic outcomes of entire papilla preservation versus open flap debridement using bovine-derived xenograft and leukocyte- and platelet-rich fibrin in the treatment of isolated intrabony defects. BMC Oral Health. 2025 Oct 21;25(1):1639. doi: 10.1186/s12903-025-07008-9.

  PMID: 41121124 DERIVED

Study Officials

• Fatma UCAN YARKAC, assoc. prof.

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dr.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 14, 2024
• Study Start: July 26, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)