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NOT YET RECRUITING
NCT07895667
NA

Adjunctive Diode Laser Therapy for Peri-Implant Mucositis

Sponsor: Universidad Europea de Valencia

View on ClinicalTrials.gov

Summary

Peri-implant mucositis is an inflammatory condition affecting the soft tissues surrounding dental implants. Conventional non-surgical treatment is primarily based on mechanical removal of bacterial biofilm, although complete and sustained resolution of inflammation may not always be achieved. This randomized controlled clinical trial aims to evaluate whether the use of diode laser therapy as an adjunct to conventional non-surgical mechanical treatment provides additional clinical and biological benefits in patients with peri-implant mucositis. Participants will be randomly assigned to receive either conventional mechanical debridement alone or mechanical debridement combined with adjunctive diode laser therapy. Clinical outcomes, including bleeding on probing, plaque index, and probing depth, will be evaluated during a 12-month follow-up period. Biological changes will also be assessed through peri-implant crevicular fluid volume and matrix metalloproteinase-8 (MMP-8) levels.

Official title: Clinical and Biological Effects of Adjunctive Diode Laser Therapy in the Non-Surgical Treatment of Peri-Implant Mucositis: A 12-Month Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2026-10-01

Completion Date

2028-06-30

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

PROCEDURE

Conventional Non-Surgical Treatment

Mechanical debridement of the peri-implant surface using Teflon curettes and an ultrasonic device equipped with a Teflon tip, followed by irrigation of the peri-implant sulcus with 0.12% chlorhexidine and 0.05% cetylpyridinium chloride. Participants will also receive individualized oral hygiene instructions based on the modified Bass technique and the use of interdental cleaning devices.

DEVICE

FOX III Diode Laser Therapy

Adjunctive diode laser therapy using a FOX III diode laser (A.R.C. Laser GmbH, Nürnberg, Germany) operating at a wavelength of 810 nm in pulsed mode with an output power of 1 W. High-intensity photothermal therapy will be delivered using a 300-µm optical fiber introduced into the peri-implant sulcus parallel to the longitudinal axis of the implant and moved in an apico-coronal direction while progressing mesiodistally around the sulcus for 30 seconds. Subsequently, low-intensity photothermal therapy will be applied using a 1-cm applicator placed in contact with the peri-implant margin for 30 seconds on the buccal and palatal/lingual surfaces.