Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

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

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).

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases; Periodontal Bone Loss; Periodontal Pocket
• Intervention / Treatment: Procedure: periodontal surgery

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio J Ortiz-Ruiz, MD; Phone Number: +34 868888581; Email: ajortiz@um.es
• Study Contact Backup: Name: José A Moreno-Rodríguez, DDS; Phone Number: +34 620538483; Email: joseantonio171087@hotmail.com

Study Locations

• Spain
  • Murcia, Spain, 30007
    • Recruiting
    • Centro Odontologico Del Sureste Slp
    • Contact: Antonio J Ortiz-Ruiz, MD; Phone Number: +34 868888581; Email: ajortiz@um.es
    • Contact: Jose A Moreno-Rodriguez; Phone Number: +34 620538483; Email: joseantonio171087@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Access flap periodontal surgery	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.
Experimental: Test; Access flap periodontal surgery and periodontal granulation tissue debridement.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment gain (CAG)	Clinical attachment gain	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rPD	residual probing depth	12 months
PPDr	Probing pocket depth reduction	12 months
iGR	interproximal gingival recession	12 months
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
SUPRA-AG	Supra-alveolar attachment gain	12 months

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Alveolar Bone Loss; Periodontal Diseases; Periodontal Pocket
• Other Study ID Numbers: 3111/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No