Laser Assisted Open Flap Debridement (LaserOpen)

September 2, 2026 updated by: Giuseppe D'Albis, University of Bari Aldo Moro

A Comparative Evaluation of Laser Assisted Open Flap Debridement: A Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70042
        • University of Bari Aldo Moro
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giuseppe D'Albis, Dr
        • Principal Investigator:
          • Mattia Marra, Dr
        • Principal Investigator:
          • Saverio Capodiferro, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mechanical Open Flap debridement
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
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.
Other Names:
  • Periodontal flap surgery
  • Access flap surgery
Experimental: Laser assisted open Flap debridement
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
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.
Other Names:
  • Laser assisted Periodontal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal probing depth
Time Frame: 3 month
Will be measured with dental prob the probing depth before 3 month of the surgery
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing
Time Frame: 3 month
The % os BoP will be value after 3 months.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari Aldo Moro

Investigators

  • Principal Investigator: Giuseppe D'Albis, Dr, University of Bari Aldo Moro
  • Study Director: Saverio Capodiferro, Prof, University of Bari Aldo Moro
  • Principal Investigator: Mattia Marra, Dr, University of Bari Aldo Moro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

November 10, 2026

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OpenFlapLaser1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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