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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997552
• Other study ID #: 2409/2019
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Universidad de Murcia
• Contact: Antonio J Ortiz-Ruiz, MD
• Phone: +34 868888581
• Email: ajortiz[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontal Pocket
• Periodontitis

Intervention

Procedure:
• Non-incised papillae surgical approach (NIPSA)
Periodontal reconstructive surgery
• marginal approach by palatal incision
Periodontal reconstructive surgery
• Minimally invasive surgical technique (MIST)
Periodontal reconstructive surgery

Locations

Country	Name	City	State
Spain	Centro Odontologico Del Sureste Slp	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	Bleeding on probing	Bleeding on probing could be positive or negative.	12 months