Recruiting NCT03997578
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NIPSA (Non-incised papilla surgical approach), NIPSA plus connective tissue graft.
- Who it may be relevant to
- Registry conditions: Periodontitis, Periodontal Bone Loss, Periodontal; Lesion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure NIPSA (Non-incised papilla surgical approach)
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 granul - Procedure NIPSA plus connective tissue graft
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 measures
- Probing pocket depth (PD) [Time frame: 12 months]
- Clinical attachment level (CAL) [Time frame: 12 months]
- Recession (REC) [Time frame: 12 months]
- Location of the tip of the papillae (TP) [Time frame: 12 months]
- Keratinized tissue width (KT) [Time frame: 12 months]
- Bleeding on probing [Time frame: 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Centro Odontologico Del Sureste Slp — Murcia
Publications
- 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
- 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
Identifiers
NCT: NCT03997578 · CEI 1864/2018 - CBE 100/2018