Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

Periodontal Diseases Clinical Trial

Official title:

Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533528
• Other study ID #: 3111/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: March 1, 2025

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

The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.

The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).

Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 1, 2025
• Est. primary completion date: December 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage III or IV periodontitis, including all grades.

• Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment.

• Interproximal plaque index <35% maintained during periodontal treatment and maintenance.

• Adherence to periodontal maintenance appointments.

Exclusion Criteria:

• Systemic disease contraindicating periodontal surgery.

• Teeth with incorrect endodontic treatment or restoration.

• Stage I or II periodontitis.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss
• Periodontal Diseases
• Periodontal Pocket

Intervention

Procedure:
• periodontal surgery
A sulcular incision will be made in the affected teeth, followed by an incision from the buccal aspect in the mid-portion of the interproximal tissues The buccal and lingual flaps will be elevated. For periodontal granulation tissue preservation group, the soft tissues covering the alveolar crest will be prepared. A third incision will separate the pocket epithelium from the soft tissue (granulation tissue) attached to the bone. The pocket epithelium will be removed. The root surfaces will be carefully scaled and planed in both groups. Ethylenediaminetetraacetic acid (24%) will be applied to the root surfaces and removed after 2 minutes with abundant saline solution. In the experimental group, the preserved attached soft tissue and the space between it and the root surface will be irrigated with 10% polyvinylpyrrolidone-iodine. Finally, the flaps will be positioned and sutured.

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	Clinical attachment gain (CAG)	Clinical attachment gain	12 months
Secondary	rPD	residual probing depth	12 months
Secondary	PPDr	Probing pocket depth reduction	12 months
Secondary	iGR	interproximal gingival recession	12 months
Secondary	Early Healing Index (EHI)	Five types of early healing will be recorded: EHI 1, complete closure of the incision line, with no fibrin; EHI 2-3, formation of a thin line or a fibrin clot in the incision area, respectively; EHI 4-5, incomplete closure with partial necrosis or necrosis of the incision area, respectively.	1 week
Secondary	SUPRA-AG	Supra-alveolar attachment gain	12 months

External Links

•   A pilot prospective study on the periodontal granulation tissue preservation in surgical periodontal disease treatment