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

NCT07886593 — Not applicable, Completed, 206 participants, Universidad Europea de Valencia

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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

RegistryNCT07886593
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment206 (Actual)
SponsorUniversidad Europea de Valencia (Other)
ConditionsPeri-implant Mucositis
InterventionsConventional Non-Surgical Treatment, Adjunctive Diode Laser Therapy (Procedure, device)
Datesstart 2022-01-26, primary completion 2024-06-19, completion 2024-06-19, first posted 2026-10-21, last updated 2026-10-21
Locations1 site in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Peri-implant Mucositis All trials of Conventional Non-Surgical Treatment All trials of Adjunctive Diode Laser Therapy

-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.

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+Detailed description

Peri-implant mucositis is a biofilm-induced inflammatory condition affecting the soft tissues surrounding dental implants and is clinically characterized by bleeding on probing in the absence of progressive marginal bone loss. Mechanical biofilm removal and reinforcement of oral hygiene remain the basis of non-surgical treatment; however, complete resolution of inflammation is not always achieved. Diode laser therapy has been proposed as an adjunctive approach because of its potential antimicrobial and photobiomodulatory effects.

This prospective, parallel-group, randomized controlled clinical trial was conducted at the University Dental Clinic of Universidad Europea de Valencia, Spain. A total of 206 participants contributed 274 eligible implants. The implant was considered the experimental unit. Eligible implants were randomized in a 1:1 ratio to either a control group receiving conventional non-surgical treatment or a test group receiving the same conventional treatment plus adjunctive diode laser therapy. Randomization was performed using block randomization stratified by smoking status.

Conventional treatment consisted of mechanical debridement with Teflon curettes and an ultrasonic device with a Teflon tip, followed by irrigation of the peri-implant sulcus with 0.12% chlorhexidine and 0.05% cetylpyridinium chloride, together with individualized oral hygiene instructions. In the test group, adjunctive diode laser therapy was performed using an 810-nm diode laser.

Clinical outcomes included bleeding on probing, plaque index, and probing depth, assessed at baseline, 4-6 weeks, 3 months, 6 months, and 12 months. Biological outcomes included peri-implant crevicular fluid volume and MMP-8 levels, assessed at baseline and 4-6 weeks. Bleeding on probing was considered the primary outcome, while plaque index, probing depth, peri-implant crevicular fluid volume, and MMP-8 were considered secondary outcomes.

+Arms and interventions

ArmTypeInterventionsDescription
Control GroupActive comparatorProcedure: Conventional Non-Surgical TreatmentParticipants 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.
Diode Laser GroupExperimentalProcedure: Conventional Non-Surgical Treatment; Device: Adjunctive Diode Laser TherapyParticipants received the same conventional non-surgical treatment as the control group plus adjunctive diode laser therapy using an 810-nm diode laser.
  • 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.
  • Adjunctive Diode Laser Therapy (Device), also known as FOX III Diode Laser, 810-nm Diode Laser: 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.

+Outcome measures

Primary outcomes

  • Change From Baseline in Bleeding on Probing (BOP) [Baseline, 4-6 weeks, 3 months, 6 months, and 12 months]: 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.

Secondary outcomes

  • Change From Baseline in Plaque Index (PI) [Baseline, 4-6 weeks, 3 months, 6 months, and 12 months]: Plaque index was assessed at six peri-implant sites according to the Silness and Löe criteria. Scores ranged from 0 to 3, with higher scores indicating greater plaque accumulation. Changes from baseline were evaluated at each follow-up visit.
  • Change From Baseline in Probing Depth (PD) [Baseline, 4-6 weeks, 3 months, 6 months, and 12 months]: Probing depth was measured in millimeters at six peri-implant sites using a periodontal probe with an approximate probing force of 0.25 N. Probing depth was defined as the distance from the peri-implant mucosal margin to the base of the peri-implant sulcus. Changes from baseline were evaluated at each follow-up visit.
  • Change From Baseline in Peri-Implant Crevicular Fluid (PICF) Volume [Baseline and 4-6 weeks]: Peri-implant crevicular fluid volume was measured using Periopaper strips and quantified with a Periotron 8010 device. Device readings were converted to fluid volume using a previously established calibration curve. Change from baseline was assessed after treatment.
  • Change From Baseline in Matrix Metalloproteinase-8 (MMP-8) Levels [Baseline and 4-6 weeks]: MMP-8 concentration in peri-implant crevicular fluid was determined using a commercially available human MMP-8 ELISA kit. Concentrations were calculated from the assay standard curve and expressed as ng/mL. Change from baseline was assessed after treatment.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

FacilityCityCountryStatus
Universidad Europea de ValenciaValencia, ValenciaSpain

+Publications

  • 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
  • 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