An interventional study of Conventional Non-Surgical Treatment and FOX III Diode Laser Therapy in Peri-implant Mucositis, sponsored by Universidad Europea de Valencia. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Universidad Europea de Valencia · Not applicable, Interventional, and Treatment
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.
Peri-implant mucositis is a biofilm-induced inflammatory condition affecting the soft tissues surrounding dental implants and is clinically characterized by bleeding on probing without progressive marginal bone loss beyond initial bone remodeling. Conventional non-surgical management is primarily based on patient biofilm control and professional mechanical debridement of the implant surface. Although this approach can reduce clinical signs of inflammation, complete and sustained resolution may not always be achieved.
Diode laser therapy has been proposed as an adjunctive approach because of its potential bacterial decontamination and photobiomodulatory effects on peri-implant tissues. However, the additional benefit of diode laser therapy over conventional mechanical treatment remains uncertain, and evidence from clinical trials with longer follow-up and combined clinical and biological assessment is limited.
The primary objective of this randomized controlled clinical trial is to evaluate the efficacy of adjunctive diode laser therapy in reducing peri-implant inflammation compared with conventional non-surgical mechanical treatment alone. Clinical response will be evaluated using bleeding on probing, plaque index, and probing depth. Biological response will be assessed through peri-implant crevicular fluid volume and matrix metalloproteinase-8 (MMP-8), a biomarker associated with inflammatory activity and extracellular matrix degradation.
The study will use a prospective, parallel-group, randomized controlled design with a 12-month follow-up. The combined assessment of clinical and biological outcomes is intended to provide a comprehensive evaluation of the potential adjunctive effect of diode laser therapy in the non-surgical management of peri-implant mucositis.
265 studies on the registry are indexed under Mucositis; 34 are open to participants now.
This study's planned enrollment of 144 is above the median of 45 across 215 interventional studies indexed under Mucositis.
Browse Mucositis studies →Universidad Europea de Valencia is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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Tapered macrodesign, internal connection, and absence of a polished collar. Located in a posterior region of the dental arch (premolar or molar site). 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:
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.
Procedure: Conventional Non-Surgical Treatment
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.
Procedure: Conventional Non-Surgical Treatment · Device: FOX III 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.
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.
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.
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Probing Depth (PD)
Probing depth will be measured at six sites per implant and defined as the distance, in millimeters, between the peri-implant mucosal margin and the base of the peri-implant sulcus. Measurements will be performed with an approximate probing force of 0.25 N using a periodontal probe.
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Plaque Index (PI)
Plaque index will be assessed at six sites per implant according to the criteria described by Silness and Löe. Changes from baseline will be evaluated during follow-up.
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Peri-Implant Crevicular Fluid (PICF) Volume
Peri-implant crevicular fluid will be collected from the mesiobuccal region using Periopaper strips. PICF volume will be quantified using a Periotron 8010 and converted from arbitrary units to volume according to a previously established calibration curve.
Time frame: Baseline and 4-6 weeks
Change in Matrix Metalloproteinase-8 (MMP-8) Levels
Total MMP-8 concentration in peri-implant crevicular fluid will be determined using a commercially available human MMP-8 ELISA kit. Absorbance will be measured at 450 nm, and MMP-8 concentrations will be calculated by interpolation from the standard curve.
Time frame: Baseline and 4-6 weeks
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data will be available following publication of the main study results and for a period of 5 years thereafter.
Access criteria: De-identified individual participant data and supporting information may be made available to qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the study investigators and must comply with applicable ethical, institutional, and data protection requirements. Requests should be directed to the Principal Investigator.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.
Of 67 non-industry interventional studies with no phase under Mucositis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 26. This study's planned 20 months is above that.
Counting every sponsor, half of 70 studies reached it within 12 months; a quarter within 6 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Universidad Europea de Valencia