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Clinical Trials/NCT06687785
NCT06687785
Active, not recruiting
Not Applicable

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

Necmettin Erbakan University1 site in 1 country28 target enrollmentJuly 26, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Intrabony Defect
Sponsor
Necmettin Erbakan University
Enrollment
28
Locations
1
Primary Endpoint
Probing Depth
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 26, 2024
End Date
February 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Uçan Yarkaç

Associate Professor, Dr.

Necmettin Erbakan University

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.

Outcomes

Primary Outcomes

Probing Depth

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Visual analogue scale(for 2 weeks after treatment)
  • Early healing index.(1 week after treatment)

Study Sites (1)

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