Laser Assisted Open Flap Debridement

NCT07807215 | Not Yet Recruiting DMC

• 1 other identifier: OpenFlapLaser1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves the surgical treatment of patients with Stage I to III of periodontitis. Following completion of Steps 1 and 2 of periodontal therapy according to the EFP guidelines for the treatment of periodontitis, sites presenting with residual probing depths greater than 5 mm and non-contained periodontal defects will undergo open-flap debridement and decontamination. In one group, debridement and decontamination will be performed using manual and ultrasonic instrumentation, whereas in the other group, the same treatment will be supplemented with laser therapy.

Conditions

Periodontal Disease; Periodontal Bone Loss

Keywords

Periodontitis; Laser; Open Flap; Minimally invasive; Coagulation; decontamination

Outcome Measures

Primary Outcomes (1)

• Periodontal probing depth

  Will be measured with dental prob the probing depth before 3 month of the surgery

  3 month

Secondary Outcomes (1)

• Bleeding on probing

  3 month

Study Arms (2)

Mechanical Open Flap debridement

ACTIVE COMPARATOR

Patients with periodontal defects ( more than 5 mm probing after step I and II). Intervention: Following flap elevation, the defects will be instrumented using manual and ultrasonic instruments.

Procedure: Mechanical Open Flap debridement

Laser assisted open Flap debridement

EXPERIMENTAL

The defects will be instrumented using manual and ultrasonic instruments follow by laser debridement and decontamination of the pockets.

Procedure: Laser assisted open flap debridement

Interventions

Mechanical Open Flap debridement PROCEDURE

Open-flap debridement will be performed under local anesthesia. Following incisions, a full-thickness mucoperiosteal flap will be elevated to provide adequate access to the periodontal defect and root surfaces. Granulation tissue will be carefully removed, and thorough root surface debridement will be performed using manual and ultrasonic devices. After instrumentation surgical site, the flap will be repositioned and stabilized with sutures to achieve appropriate wound closure.

Also known as: Periodontal flap surgery, Access flap surgery

Mechanical Open Flap debridement

Laser assisted open flap debridement PROCEDURE

Open-flap debridement will be performed under local anesthesia. Following intrasulcular incisions, a full-thickness mucoperiosteal flap will be elevated to provide adequate access to the periodontal defect and root surfaces. Granulation tissue will be carefully removed, and thorough root surface debridement will be performed using manual and ultrasonic instrumentation. In the test group, laser irradiation will subsequently be performed within the periodontal pocket and on the exposed root surface as an adjunctive decontamination procedure. After instrumentation, laser treatment, and irrigation of the surgical site, the flap will be repositioned and stabilized with sutures to achieve appropriate wound closure.

Also known as: Laser assisted Periodontal surgery

Laser assisted open Flap debridement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults in good general health
• Signed informed consent
• Periodontal disease treated with non surgical step.

You may not qualify if:

• Systemic conditions affecting bone healing
• Uncontrolled periodontal disease
• Smoking \>10 cigarettes/day
• Pregnancy or lactation
• Use of medications interfering with bone metabolism

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

University of Bari Aldo Moro

Bari, BA, 70042, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases; Alveolar Bone Loss; Periodontitis; Thrombosis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Giuseppe D'Albis, Dr

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

• Mattia Marra, Dr

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

• Saverio Capodiferro, Prof

  University of Bari Aldo Moro

  STUDY DIRECTOR

Central Study Contacts

Giuseppe D'Albis, Dr.

CONTACT

3495103642; giuseppe.dalbis@uniba.it

Mattia Marra, Dr.

CONTACT

mattiamarra21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)