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
Sponsor study identifier
Secondary identifiers
REGISTRY · Clinical Research Ethics Committee, Hospital Clínico San Carlos, Madrid
interventional
144
0 countries
N/A
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 19, 2026
Actual (reported)October 26, 2026
Actual (reported)June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Bleeding on Probing (BOP)
Bleeding on probing will be assessed at six sites per implant using the modified peri-implant index described by Mombelli. Probing will be performed with an approximate force of 0.25 N using a periodontal probe. Changes from baseline will be compared between the conventional non-surgical treatment group and the adjunctive diode laser group.
Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Probing Depth (PD)
Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Plaque Index (PI)
Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Peri-Implant Crevicular Fluid (PICF) Volume
Baseline and 4-6 weeks
Change in Matrix Metalloproteinase-8 (MMP-8) Levels
Baseline and 4-6 weeks
Participants allocated to the control group will receive conventional non-surgical treatment for peri-implant mucositis consisting of mechanical debridement of the peri-implant surface, 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.
Participants allocated to the test group will receive conventional non-surgical treatment for peri-implant mucositis combined with adjunctive high- and low-intensity photothermal diode laser therapy.
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.
First Submitted
October 19, 2026
First Posted
October 26, 2026
Study Start
October 1, 2026
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-09
De-identified individual participant data underlying the results reported in the study may be shared with qualified researchers upon reasonable request, subject to approval by the study investigators and applicable ethical and data protection requirements.
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Source: ClinicalTrials.gov.
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