Three Types of Papilla Incision in Periodontal Surgery

NCT ID: NCT06428149

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-12-01

Brief Summary

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

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Midline interproximal soft-tissue incision

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Marginal approach by palatal incision

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Minimally invasive surgical technique

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Antonio José Ortiz Ruiz, MD

Professor and researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Odontologico Del Sureste Slp

Murcia, Murcia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

ANTONIO J ORTIZ-RUIZ, MD

Role: CONTACT

ajortiz@um.es

+34 868888581

Facility Contacts

JOSÉ ANTONIO MORENO-RODRIGUEZ, DDS

Role: primary

+34 620538483

Other Identifiers

2937/2020

Identifier Type: -

Identifier Source: org_study_id