Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

NCT ID: NCT05533528

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2026-02-01

Brief Summary

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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).

Detailed Description

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Conditions

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Periodontal Pocket Periodontal Diseases Periodontal Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Access flap periodontal surgery

Group Type ACTIVE_COMPARATOR

periodontal surgery

Intervention Type PROCEDURE

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.

Test

Access flap periodontal surgery and periodontal granulation tissue debridement.

Group Type EXPERIMENTAL

periodontal surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Antonio José Ortiz Ruiz, MD

Professor and researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro Odontologico Del Sureste Slp

Murcia, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Antonio J Ortiz-Ruiz, MD

Role: CONTACT

+34 868888581

José A Moreno-Rodríguez, DDS

Role: CONTACT

+34 620538483

Facility Contacts

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Antonio J Ortiz-Ruiz, MD

Role: primary

+34 868888581

Jose A Moreno-Rodriguez

Role: backup

+34 620538483

Related Links

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http://doi.org/10.5051/jpis.2105780289

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

Other Identifiers

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3111/2020

Identifier Type: -

Identifier Source: org_study_id

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