NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration

Universidad de Murcia

Status: Enrolling

Conditions: Periodontitis; Periodontal Pocket; Periodontal Diseases

Treatments: Procedure: marginal approach by palatal incision; Procedure: Non-incised papillae surgical approach (NIPSA); Procedure: Minimally invasive surgical technique (MIST)

Study type: Interventional

Funder types: Other

Identifiers

NCT03997552

2409/2019

Details and patient eligibility

About

Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients diagnosed with periodontitis.
• plaque index and bleeding index of < 30%.
• periodontal lesions with pocket probing depth > 5 mm.
• intrabony defect > 3 mm.
• intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion criteria

• patients with systemic diseases that contraindicated treatment.
• third molars.
• teeth with incorrect endodontic or restorative treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Non-incised papillae surgical approach (NIPSA)

Experimental group

Description:

To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesiodistally as necessary to allow access to the defect and correct debridement of the granulation tissue. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures.

Treatment:

Procedure: Non-incised papillae surgical approach (NIPSA)

marginal approach by palatal incision

Active Comparator group

Description:

A small incision in the palatal aspect and a limited papila elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.

Treatment:

Procedure: marginal approach by palatal incision

Minimally invasive surgical technique (MIST)

Active Comparator group

Description:

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.

Treatment:

Procedure: Minimally invasive surgical technique (MIST)