Three Types of Papilla Incision in Periodontal Surgery

Wound Healing After Different Types of Papilla Incision in Periodontal Reconstruction Surgery. A Randomized Clinical Trial

Three types of papilla incision in periodontal reconstruction techniques will be compared.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Periodontal Diseases; Periodontal Pocket
• Intervention / Treatment: Procedure: Midline interproximal soft-tissue incision; Procedure: Marginal approach by palatal incision; Procedure: Minimally invasive surgical technique

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANTONIO J ORTIZ-RUIZ, MD; Phone Number: +34 868888581; Email: ajortiz@um.es

Study Locations

• Spain
  • Murcia, Spain, 30007
    • Recruiting
    • Centro Odontologico Del Sureste Slp
    • Contact: JOSÉ ANTONIO MORENO-RODRIGUEZ, DDS; Phone Number: +34 620538483

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with periodontal disease.
• Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.
• Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.
• Plaque index and bleeding index less than 30%.

Exclusion Criteria:

• Systemic disease that contraindicates periodontal surgery.
• Pregnant women.
• Third molars or teeth with incorrect endodontic or restorative treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midline interproximal soft-tissue incision; Marginal approach by midline interproximal soft tissue incision and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.	Procedure: Midline interproximal soft-tissue incision; Firstly, the marginal tissue will be elevated around the periodontal defect, through the tunneling of the tissues, entering through the gingival sulcus and the periodontal pocket of the teeth involved in the defect periodontal. Once the marginal tissues have been disinserted to full thickness, the soft supra-alveolar component of the defect to be reconstructed will be stretched, in a buccal direction, with a blunt instrument, applying pressure on the lingual aspect. Visualizing the midpoint of the interproximal tissue, the papilla will be dissected at its midpoint, entering through the mesial aspect, with the scalpel blade perpendicular to the central axis of the teeth.
Active Comparator: Marginal approach by palatal incision; A small incision in the palatal aspect and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.	Procedure: Marginal approach by palatal incision; First, an incision will be made in the palatal aspect of the interproximal papilla, at the base of the papilla, parallel to the axis of the tooth until touching the palatine alveolar crest, in order to detach and move the papilla from its base, attached to the vestibular flap. From the palatal incision the interproximal tissue will be elevated towards the buccal until the buccal bone crest is exposed.
Active Comparator: Minimally invasive surgical technique; The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures.	Procedure: Minimally invasive surgical technique; The defect will be accessed through an incision at the base of the papilla on the vestibular aspect. Depending on the anatomy of the interproximal space, two types of incisions will be made: simplified papilla preservation flap (SPPF) when the width of the interproximal space is equal to or less than 2 mm, or modified papilla preservation technique (MPPT) when the width is greater than 2 millimeters. The interproximal incision will extend intrasulcular on the lingual and buccal aspect of the teeth adjacent to the defect, and mesio-distally it will extend as necessary to allow access to the defect and its debridement. The papilla will move from its base towards the palatine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth (PD)	Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket	12 months
Recession (REC)	Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.	12 months
Keratinized tissue width (KT)	Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.	12 months
Bleeding on probing	Bleeding on probing could be positive or negative	12 months
Clinical attachment level (CAL)	Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket	12 months
Location of the tip of the papillae (TP)	Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mm.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supra-alveolar attachment gain (SUPRA-AG)	Subtracting the 12 month CAL from the intrasurgically Bone Component-CEJ will provide the SUPRA-AG result.	12 months

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Periodontal Pocket
• Other Study ID Numbers: 2937/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No