Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
Primary Purpose
Periodontitis, Periodontal Bone Loss, Periodontal; Lesion
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
NIPSA (Non-incised papilla surgical approach)
NIPSA plus connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
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.
Sites / Locations
- Centro Odontologico Del Sureste SlpRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
NIPSA
NIPSA plus Connective tissue graft
Arm Description
Patients will be treated with only NIPSA technique.
Patients will be treated with NIPSA technique associated to a connective tissue graft.
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
1. Study Identification
Unique Protocol Identification Number
NCT03997578
Brief Title
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
Official Title
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Enamel Matrix Derivated and Xenograft for the Treatment of Periodontal Defects: A Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
April 1, 2024 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Bone Loss, Periodontal; Lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIPSA
Arm Type
Active Comparator
Arm Description
Patients will be treated with only NIPSA technique.
Arm Title
NIPSA plus Connective tissue graft
Arm Type
Experimental
Arm Description
Patients will be treated with NIPSA technique associated to a connective tissue graft.
Intervention Type
Procedure
Intervention Name(s)
NIPSA (Non-incised papilla surgical approach)
Intervention 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 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.
Intervention Type
Procedure
Intervention Name(s)
NIPSA plus connective tissue graft
Intervention Description
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.
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
+34868888581
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
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
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
result
Learn more about this trial
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
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