Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft

NCT04712630 | Completed

• 1 other identifier: 2441/2019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket; Periodontal Attachment 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 mm.

  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

Secondary Outcomes (2)

• Supra-alveolar attachment gain (SUPRA-AG)

  12 months

• Wound closure (WC)

  1 week

Study Arms (2)

NIPSA without grafting biomaterial

EXPERIMENTAL

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 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 papila surgical approach without grafting biomaterial

NIPSA with grafting biomaterial

ACTIVE COMPARATOR

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 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 and the bone defect will be filled with a composite of xenograft and enamel matrix derivates. 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 papila surgical approach with grafting biomaterial

Interventions

Non-incised papila surgical approach without grafting biomaterial PROCEDURE

Periodontal reconstructive surgery

NIPSA without grafting biomaterial

Non-incised papila surgical approach with grafting biomaterial PROCEDURE

Periodontal reconstructive surgery

NIPSA with grafting biomaterial

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

Location

Related Publications (4)

• Moreno Rodriguez JA, Caffesse RG. Nonincised Papillae Surgical Approach (NIPSA) in Periodontal Regeneration: Preliminary Results of a Case Series. Int J Periodontics Restorative Dent. 2018;38(Suppl):s105-s111. doi: 10.11607/prd.3195.

  PMID: 30118534 BACKGROUND

• 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 BACKGROUND

• Moreno Rodriguez JA, Ortiz Ruiz AJ. Apical approach in periodontal reconstructive surgery with enamel matrix derivate and enamel matrix derivate plus bone substitutes: a randomized, controlled clinical trial. Clin Oral Investig. 2022 Mar;26(3):2793-2805. doi: 10.1007/s00784-021-04256-1. Epub 2021 Nov 17.

  PMID: 34791548 DERIVED

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and researcher

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: September 9, 2019
• Primary Completion: September 9, 2020
• Study Completion: December 30, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)