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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03997552
Enrollment
60
Registered
2019-06-25
Start date
2019-09-06
Completion date
2027-02-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Periodontal Pocket, Periodontitis

Brief summary

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

Interventions

PROCEDURENon-incised papillae surgical approach (NIPSA)

Periodontal reconstructive surgery

Periodontal reconstructive surgery

Periodontal reconstructive surgery

Sponsors

Universidad de Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Probing pocket depth (PD)12 monthsProbing 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)12 monthsClinical 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)12 monthsRecession, 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)12 monthsLocation 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)12 monthsKeratinized 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 probing12 monthsBleeding on probing could be positive or negative.

Countries

Spain

Contacts

CONTACTAntonio J Ortiz-Ruiz, MD
ajortiz@um.es+34 868888581
CONTACTJose A Moreno-Rodriguez
joseantonio171087@hotmail.com+34 620538483

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026