Three Types of Papilla Incision in Periodontal Surgery

NCT06428149 | Recruiting

• 1 other identifier: 2937/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Supra-alveolar attachment gain (SUPRA-AG)

  12 months

Study Arms (3)

Midline interproximal soft-tissue incision

EXPERIMENTAL

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

Marginal approach by palatal incision

ACTIVE COMPARATOR

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

Minimally invasive surgical technique

ACTIVE COMPARATOR

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

Interventions

Midline interproximal soft-tissue incision PROCEDURE

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.

Midline interproximal soft-tissue incision

Marginal approach by palatal incision PROCEDURE

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.

Marginal approach by palatal incision

Minimally invasive surgical technique PROCEDURE

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.

Minimally invasive surgical technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Centro Odontologico Del Sureste Slp

Murcia, Murcia, 30007, Spain

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

ANTONIO J ORTIZ-RUIZ, MD

CONTACT

+34 868888581; ajortiz@um.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and researcher

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

ES (1)