Recruiting NCT03997552
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
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: Non-incised papillae surgical approach (NIPSA), marginal approach by palatal incision, Minimally invasive surgical technique (MIST).
- Who it may be relevant to
- Registry conditions: Periodontitis, Periodontal Diseases, Periodontal Pocket. 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 →
Unsure about the terms? Read our patient guide →
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
Overview
Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.
Interventions
- Procedure Non-incised papillae surgical approach (NIPSA)
Periodontal reconstructive surgery - Procedure marginal approach by palatal incision
Periodontal reconstructive surgery - Procedure Minimally invasive surgical technique (MIST)
Periodontal reconstructive surgery
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. 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
- 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
Identifiers
NCT: NCT03997552 · 2409/2019