NCT05533528

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
May 2022Feb 2027

Study Start

First participant enrolled

May 3, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.6 years

First QC Date

September 5, 2022

Last Update Submit

February 16, 2026

Conditions

Periodontal PocketPeriodontal DiseasesPeriodontal Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Clinical attachment gain (CAG)

    Clinical attachment gain

    12 months

Secondary Outcomes (5)

  • rPD

    12 months

  • PPDr

    12 months

  • iGR

    12 months

  • Early Healing Index (EHI)

    1 week

  • SUPRA-AG

    12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Access flap periodontal surgery

Procedure: periodontal surgery

Test

EXPERIMENTAL

Access flap periodontal surgery and periodontal granulation tissue debridement.

Procedure: periodontal surgery

Interventions

periodontal surgeryPROCEDURE

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.

ControlTest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Systemic disease contraindicating periodontal surgery.
  • Teeth with incorrect endodontic treatment or restoration.
  • Stage I or II periodontitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Odontologico Del Sureste Slp

Murcia, 30007, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Periodontal PocketPeriodontal DiseasesAlveolar Bone Loss

Condition Hierarchy (Ancestors)

PeriodontitisMouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Central Study Contacts

Antonio J Ortiz-Ruiz, MD

CONTACT

+34 868888581ajortiz@um.es

José A Moreno-Rodríguez, DDS

CONTACT

+34 620538483joseantonio171087@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and researcher

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 9, 2022

Study Start

May 3, 2022

Primary Completion (Estimated)

December 22, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)