Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997578
• Other study ID #: CEI 1864/2018 - CBE 100/2018
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2023
• Source: Universidad de Murcia
• Contact: Antonio J Ortiz-Ruiz, MD
• Phone: +34868888581
• Email: ajortiz[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: April 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

• Alveolar Bone Loss
• Periodontal Bone Loss
• Periodontal; Lesion
• Periodontitis

Intervention

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 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.
• 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.

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. — 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