Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

• Sponsor: Universidad de Murcia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05533528
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The objective of our 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.

We 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).

Condition or Disease	Intervention/Treatment	Phase
Periodontal Pocket; Periodontal Diseases; Periodontal Bone Loss	Procedure: periodontal surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial
• Actual Study Start Date: May 3, 2022
• Anticipated Primary Completion Date: Dec 22, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. CAG [12 months]

   Clinical attachment gain

Secondary Outcome Measures

1. rPD [12 months]

   residual probing depth

2. PPDr [12 months]

   Probing pocket depth reduction

3. iGR [12 months]

   interproximal gingival recession

4. EHI [1 week]

   early healing index

5. SUPRA-AG [12 months]

   Supra-alveolar attachment gain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Odontologico Del Sureste Slp	Murcia		Spain	30007

Sponsors and Collaborators

• Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Universidad de Murcia
• ClinicalTrials.gov Identifier: NCT05533528
• Other Study ID Numbers: 3111/2020
• First Posted: Sep 9, 2022
• Last Update Posted: Sep 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alveolar Bone Loss; Periodontal Diseases; Periodontal Pocket

Study Results

No Results Posted as of Sep 9, 2022