Diode Laser Added to Non-Surgical Treatment for Peri-Implant Mucositis

NCT07886593 | Completed

• 1 other identifier: UEV-PIM-DL-2022
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial evaluated the clinical and biological effects of adjunctive diode laser therapy in the non-surgical treatment of peri-implant mucositis. Adult participants with peri-implant mucositis were allocated to receive either conventional non-surgical mechanical treatment alone or the same treatment combined with adjunctive diode laser therapy. Clinical outcomes included bleeding on probing, plaque index, and probing depth, assessed at baseline and during a 12-month follow-up. Biological outcomes included peri-implant crevicular fluid volume and matrix metalloproteinase-8 (MMP-8) levels, assessed at baseline and 4-6 weeks after treatment. The implant was considered the experimental unit.

Conditions

Peri-implant Mucositis

Keywords

Peri-implant mucositis; Diode laser; Non-surgical treatment

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Bleeding on Probing (BOP)

  leeding on probing was assessed at six peri-implant sites using the modified peri-implant bleeding index described by Mombelli. Scores ranged from 0 to 3, with higher scores indicating greater bleeding severity. Changes from baseline were calculated for each follow-up visit relative to the baseline value.

  Baseline, 4-6 weeks, 3 months, 6 months, and 12 months

Secondary Outcomes (4)

• Change From Baseline in Plaque Index (PI)

  Baseline, 4-6 weeks, 3 months, 6 months, and 12 months

• Change From Baseline in Probing Depth (PD)

  Baseline, 4-6 weeks, 3 months, 6 months, and 12 months

• Change From Baseline in Peri-Implant Crevicular Fluid (PICF) Volume

  Baseline and 4-6 weeks

• Change From Baseline in Matrix Metalloproteinase-8 (MMP-8) Levels

  Baseline and 4-6 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants received conventional non-surgical treatment for peri-implant mucositis, including mechanical debridement with Teflon curettes and an ultrasonic device with a Teflon tip, irrigation with 0.12% chlorhexidine and 0.05% cetylpyridinium chloride, and individualized oral hygiene instructions.

Procedure: Conventional Non-Surgical Treatment

Diode Laser Group

EXPERIMENTAL

Participants received the same conventional non-surgical treatment as the control group plus adjunctive diode laser therapy using an 810-nm diode laser.

Procedure: Conventional Non-Surgical Treatment; Device: Adjunctive Diode Laser Therapy

Interventions

Conventional Non-Surgical Treatment PROCEDURE

Mechanical debridement of the peri-implant surface was performed using Teflon curettes (Implant Deplaquers®, KerrHawe SA) and an ultrasonic device equipped with a PH1 Teflon tip (Acteon Satelec®). The peri-implant sulcus was subsequently irrigated with 0.12% chlorhexidine and 0.05% cetylpyridinium chloride. Participants also received individualized oral hygiene instructions based on the modified Bass technique and the use of interdental cleaning devices.

Control Group; Diode Laser Group

Adjunctive Diode Laser Therapy DEVICE

Adjunctive diode laser therapy was performed 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. For high-intensity photothermal therapy, a 300-µm optical fiber was 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 was applied using a 1-cm applicator placed in contact with the peri-implant margin for 30 seconds on the buccal and palatal/lingual surfaces.

Also known as: FOX III Diode Laser, 810-nm Diode Laser

Diode Laser Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with a diagnosis of peri-implant mucositis according to the 2017 World Workshop criteria.
• Presence of at least one eligible dental implant with a tapered macrodesign, internal connection, and no polished collar.
• Implant located in a posterior region of the dental arch (premolar or molar). Implant supporting a fixed screw-retained prosthetic restoration consisting of either a single crown or two splinted crowns supported by two implants without an intervening pontic.

You may not qualify if:

• Systemic diseases capable of altering the immune response.
• Chronic use of non-steroidal anti-inflammatory drugs.
• Systemic antibiotic therapy during the previous 6 months.
• Non-surgical peri-implant treatment during the previous 6 months.
• Surgical peri-implant treatment during the previous 12 months.
• Previous treatment with bisphosphonates or calcium supplements.
• History of radiotherapy to the head and neck region.

Sponsors & Collaborators

• Universidad Europea de Valencia: lead

Study Sites (1)

Universidad Europea de Valencia

Valencia, Valencia, 46009, Spain

Location

Related Publications (2)

• Sanchez-Martos R, Samman A, Priami M, Arias-Herrera S. The diode laser as coadyuvant therapy in the non-surgical conventional treatment of peri-implant mucositis: A systematic review and meta-analysis. J Clin Exp Dent. 2020 Dec 1;12(12):e1171-e1182. doi: 10.4317/jced.57630. eCollection 2020 Dec.

  PMID: 33282139 BACKGROUND

• Sanchez-Martos R, Samman A, Bouazza-Juanes K, Diaz-Fernandez JM, Arias-Herrera S. Clinical effect of diode laser on peri-implant tissues during non-surgical peri-implant mucositis therapy: Randomized controlled clinical study. J Clin Exp Dent. 2020 Jan 1;12(1):e13-e21. doi: 10.4317/medoral.56424. eCollection 2020 Jan.

  PMID: 31976039 BACKGROUND

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants and the clinician performing the treatment and clinical assessments were not blinded to treatment allocation. Statistical analyses were performed using coded treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Dean, Faculty of Health Sciences

Model Details: Eligible implants were randomized in a 1:1 ratio to one of two parallel treatment groups. Randomization was performed at the implant level using block randomization stratified by the participant's smoking status. Participants could contribute one or two eligible implants, and each implant received only the intervention corresponding to its assigned treatment group.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: January 26, 2022
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)