Three Types of Papilla Incision in Periodontal Surgery

Periodontitis Clinical Trial

Official title:

Wound Healing After Different Types of Papilla Incision in Periodontal Reconstruction Surgery. A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428149
• Other study ID #: 2937/2020
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• 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 types of papilla incision in periodontal reconstruction techniques will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with periodontal disease.

• Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.

• Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.

• Plaque index and bleeding index less than 30%.

Exclusion Criteria:

• Systemic disease that contraindicates periodontal surgery.

• Pregnant women.

• Third molars or teeth with incorrect endodontic or restorative treatment.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontal Pocket
• Periodontitis

Intervention

Procedure:
• Midline interproximal soft-tissue incision
Firstly, the marginal tissue will be elevated around the periodontal defect, through the tunneling of the tissues, entering through the gingival sulcus and the periodontal pocket of the teeth involved in the defect periodontal. Once the marginal tissues have been disinserted to full thickness, the soft supra-alveolar component of the defect to be reconstructed will be stretched, in a buccal direction, with a blunt instrument, applying pressure on the lingual aspect. Visualizing the midpoint of the interproximal tissue, the papilla will be dissected at its midpoint, entering through the mesial aspect, with the scalpel blade perpendicular to the central axis of the teeth.
• Marginal approach by palatal incision
First, an incision will be made in the palatal aspect of the interproximal papilla, at the base of the papilla, parallel to the axis of the tooth until touching the palatine alveolar crest, in order to detach and move the papilla from its base, attached to the vestibular flap. From the palatal incision the interproximal tissue will be elevated towards the buccal until the buccal bone crest is exposed.
• Minimally invasive surgical technique
The defect will be accessed through an incision at the base of the papilla on the vestibular aspect. Depending on the anatomy of the interproximal space, two types of incisions will be made: simplified papilla preservation flap (SPPF) when the width of the interproximal space is equal to or less than 2 mm, or modified papilla preservation technique (MPPT) when the width is greater than 2 millimeters. The interproximal incision will extend intrasulcular on the lingual and buccal aspect of the teeth adjacent to the defect, and mesio-distally it will extend as necessary to allow access to the defect and its debridement. The papilla will move from its base towards the palatine.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing	Bleeding on probing could be positive or negative	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	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	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 mm.	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
Secondary	Supra-alveolar attachment gain (SUPRA-AG)	Subtracting the 12 month CAL from the intrasurgically Bone Component-CEJ will provide the SUPRA-AG result.	12 months