search
Back to results

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

Primary Purpose

Periodontitis, Periodontal Diseases, Periodontal Pocket

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-incised papila surgical approach without grafting biomaterial
Non-incised papila surgical approach with grafting biomaterial
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centro Odontologico Del Sureste Slp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIPSA without grafting biomaterial

NIPSA with grafting biomaterial

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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.
Bleeding on probing
Bleeding on probing could be positive or negative.

Secondary Outcome Measures

Supra-alveolar attachment gain (SUPRA-AG)
Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result.
Wound closure (WC)
Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0).

Full Information

First Posted
January 14, 2021
Last Updated
January 14, 2021
Sponsor
Universidad de Murcia
search

1. Study Identification

Unique Protocol Identification Number
NCT04712630
Brief Title
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
Acronym
NIPSAGRAFT
Official Title
Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIPSA without grafting biomaterial
Arm Type
Experimental
Arm Description
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.
Arm Title
NIPSA with grafting biomaterial
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-incised papila surgical approach without grafting biomaterial
Intervention Description
Periodontal reconstructive surgery
Intervention Type
Procedure
Intervention Name(s)
Non-incised papila surgical approach with grafting biomaterial
Intervention Description
Periodontal reconstructive surgery
Primary Outcome Measure Information:
Title
Probing pocket depth (PD)
Description
Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
Time Frame
12 months
Title
Clinical attachment level (CAL)
Description
Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.
Time Frame
12 months
Title
Recession (REC)
Description
Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Time Frame
12 months
Title
Location of the tip of the papillae (TP)
Description
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.
Time Frame
12 months
Title
Keratinized tissue width (KT)
Description
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.
Time Frame
12 months
Title
Bleeding on probing
Description
Bleeding on probing could be positive or negative.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Supra-alveolar attachment gain (SUPRA-AG)
Description
Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result.
Time Frame
12 months
Title
Wound closure (WC)
Description
Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0).
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro Odontologico Del Sureste Slp
City
Murcia
ZIP/Postal Code
30007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30118534
Citation
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.
Results Reference
background
PubMed Identifier
30421495
Citation
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.
Results Reference
background
PubMed Identifier
31190409
Citation
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.
Results Reference
background
PubMed Identifier
34791548
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs