Laser Assisted Open Flap Debridement

NCT07807215 — Not applicable, Not yet recruiting, 20 participants, University of Bari Aldo Moro

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

Registry	NCT07807215, acronym LaserOpen
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	20 (Estimated)
Sponsor	University of Bari Aldo Moro (Other)
Conditions	Periodontal Disease, Periodontal Bone Loss
Interventions	Mechanical Open Flap debridement, Laser assisted open flap debridement (Procedure)
Dates	start 2026-09-10 (estimated), primary completion 2026-10-10 (estimated), completion 2026-11-10 (estimated), first posted 2026-09-08, last updated 2026-09-10
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Mechanical Open Flap debridement	Active comparator	Procedure: 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.
Laser assisted open Flap debridement	Experimental	Procedure: Laser assisted open flap debridement	The defects will be instrumented using manual and ultrasonic instruments follow by laser debridement and decontamination of the pockets.

Mechanical Open Flap debridement (Procedure), also known as Periodontal flap surgery, Access flap surgery: 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.
Laser assisted open flap debridement (Procedure), also known as Laser assisted Periodontal surgery: 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.

+Outcome measures

Primary outcomes

Periodontal probing depth [3 month]: Will be measured with dental prob the probing depth before 3 month of the surgery

Secondary outcomes

Bleeding on probing [3 month]: The % os BoP will be value after 3 months.

+Eligibility

Sex: All, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of Bari Aldo Moro	Bari, BA	Italy

+Investigators

Giuseppe D'Albis, Dr, Principal investigator, University of Bari Aldo Moro
Mattia Marra, Dr, Principal investigator, University of Bari Aldo Moro
Saverio Capodiferro, Prof, Study director, University of Bari Aldo Moro