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

February 16, 2026 updated by: Antonio José Ortiz Ruiz, MD, Universidad de Murcia

Non-Incised Papillae Surgical Approach (NIPSA) Versus Marginal Approach by Palatal Incision and Minimally Invasive Surgical Technique (MIST) in Periodontal Regeneration: a Ramdomized Clinical Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antonio J Ortiz-Ruiz, MD
  • Phone Number: +34 868888581
  • Email: ajortiz@um.es

Study Contact Backup

Study Locations

  • Spain
      • Murcia, Spain, 30007
        • Recruiting
        • Centro Odontologico Del Sureste Slp
        • Contact:
          • Antonio J Ortiz-Ruiz, MD
          • Phone Number: +34 868888581
          • Email: ajortiz@um.es
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-incised papillae surgical approach (NIPSA)
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)
Periodontal reconstructive surgery
Active Comparator: marginal approach by palatal incision
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
Periodontal reconstructive surgery
Active Comparator: Minimally invasive surgical technique (MIST)
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)
Periodontal reconstructive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth (PD)
Time Frame: 12 months
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)
Time Frame: 12 months
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)
Time Frame: 12 months
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)
Time Frame: 12 months

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)
Time Frame: 12 months
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
Time Frame: 12 months
Bleeding on probing could be positive or negative.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 22, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2409/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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