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

NCT03997552 | Recruiting

• 1 other identifier: 2409/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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 mmm.

  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

Study Arms (3)

Non-incised papillae surgical approach (NIPSA)

EXPERIMENTAL

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.

Procedure: Non-incised papillae surgical approach (NIPSA)

marginal approach by palatal incision

ACTIVE COMPARATOR

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.

Procedure: marginal approach by palatal incision

Minimally invasive surgical technique (MIST)

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 (MIST)

Interventions

Non-incised papillae surgical approach (NIPSA) PROCEDURE

Periodontal reconstructive surgery

Non-incised papillae surgical approach (NIPSA)

marginal approach by palatal incision PROCEDURE

Periodontal reconstructive surgery

marginal approach by palatal incision

Minimally invasive surgical technique (MIST) PROCEDURE

Periodontal reconstructive surgery

Minimally invasive surgical technique (MIST)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Centro Odontologico Del Sureste Slp

Murcia, 30007, Spain

RECRUITING

Related Publications (2)

• Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.

  PMID: 30421495 BACKGROUND

• Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.

  PMID: 31190409 RESULT

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

Jose A Moreno-Rodriguez

CONTACT

+34 620538483; joseantonio171087@hotmail.com

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: June 21, 2019
• First Posted: June 25, 2019
• Study Start: September 6, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)