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

Primary Purpose

Periodontitis, Periodontal Diseases, Periodontal Pocket

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-incised papillae surgical approach (NIPSA)
marginal approach by palatal incision
Minimally invasive surgical technique (MIST)
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 SlpRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Non-incised papillae surgical approach (NIPSA)

marginal approach by palatal incision

Minimally invasive surgical technique (MIST)

Arm Description

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.

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.

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.

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 mmm.
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

Full Information

First Posted
June 21, 2019
Last Updated
May 4, 2023
Sponsor
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT03997552
Brief Title
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-incised papillae surgical approach (NIPSA)
Arm Type
Experimental
Arm Description
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.
Arm Title
marginal approach by palatal incision
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimally invasive surgical technique (MIST)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-incised papillae surgical approach (NIPSA)
Intervention Description
Periodontal reconstructive surgery
Intervention Type
Procedure
Intervention Name(s)
marginal approach by palatal incision
Intervention Description
Periodontal reconstructive surgery
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive surgical technique (MIST)
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 mmm.
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

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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name or Official Title & Degree
Jose A Moreno-Rodriguez
Phone
+34 620538483
Email
joseantonio171087@hotmail.com
Facility Information:
Facility Name
Centro Odontologico Del Sureste Slp
City
Murcia
ZIP/Postal Code
30007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name & Degree
Jose A Moreno-Rodriguez
Phone
+34 620538483
Email
joseantonio171087@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
result

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

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