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Clinical Trials/NCT06003322
NCT06003322
Recruiting
Not Applicable

Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial

Ain Shams University1 site in 1 country20 target enrollmentAugust 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Attachment Loss
Sponsor
Ain Shams University
Enrollment
20
Locations
1
Primary Endpoint
interproximal clinical attachment level change
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Detailed Description

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA. Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Registry
clinicaltrials.gov
Start Date
August 7, 2023
End Date
September 7, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alaa Talaat Ali

lecturer

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • - Age \> 18 years
  • Diagnosis with stage III-IV periodontitis.
  • Presence of one or more intrabony defects with probing pocket depth (PPD) \> 5 mm and radiographic defect depth \> 4 mm.
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \< 30% (measured at four sites per tooth).
  • No relevant systemic condition or disease.

Exclusion Criteria

  • Third molars and teeth with type III mobility or with an incorrect endodontic or restorative treatment.

Outcomes

Primary Outcomes

interproximal clinical attachment level change

Time Frame: at baseline ,6 and 12 months

CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe

Secondary Outcomes

  • residual probing pocket depth (PPD), pocket depth (PD) change,(at at baseline ,6 and 12 months)

Study Sites (1)

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