NCT03997578

Brief Summary

The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Sep 2019Feb 2027

First Submitted

Initial submission to the registry

June 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 3, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

7.2 years

First QC Date

June 21, 2019

Last Update Submit

February 16, 2026

Conditions

Periodontal; LesionPeriodontitisPeriodontal Bone Loss

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 (2)

NIPSA

ACTIVE COMPARATOR

Patients will be treated with only NIPSA technique.

Procedure: NIPSA (Non-incised papilla surgical approach)

NIPSA plus Connective tissue graft

EXPERIMENTAL

Patients will be treated with NIPSA technique associated to a connective tissue graft.

Procedure: NIPSA plus connective tissue graft

Interventions

NIPSA (Non-incised papilla surgical approach)PROCEDURE

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 regenerative biomaterials 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.

NIPSA
NIPSA plus connective tissue graftPROCEDURE

In these patients, the following methodology will be added to the technique described for the NIPSA group: once the biomaterials are applied, a connective tissue graft, taken at the level of the first upper molar, will be sutured to the base of the soft supra-alveolar tissue and to the palatal tissue, which has not been disinserted, using simple sutures.

NIPSA plus Connective tissue graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Odontologico Del Sureste Slp

Murcia, 30007, Spain

RECRUITING

Related Publications (2)

  • 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: 31190409RESULT

  • 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: 30421495RESULT

MeSH Terms

Conditions

PeriodontitisAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Central Study Contacts

Antonio J Ortiz-Ruiz, MD

CONTACT

+34868888581ajortiz@um.es

Jose A Moreno-Rodriguez

CONTACT

+34 620538483joseantonio171087@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 3, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 2, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)