An interventional study of Conventional Non-Surgical Treatment and Adjunctive Diode Laser Therapy in Peri-implant Mucositis, sponsored by Universidad Europea de Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Universidad Europea de Valencia · Not applicable, Interventional, and Treatment
Among 17 studies in Mucositis with a site in Spain — 3 open to participants now, 3 under way, none of them phase 3. Mucositis · Spain.
Among the 17 studies in Mucositis with a site in Spain, this one has the largest enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2022, is one of 8 with no phase, and was the 17th registered.
265 studies on the registry are indexed under Mucositis; 34 are open to participants now.
Browse Mucositis studies →3 of the 17 studies in Mucositis with a site in Spain are open now. Recruiting first, the newest first:
University of Barcelona · Sites in Spain
Mucosa Innovations, S.L. · Sites in Spain
Mucosa Innovations, S.L. · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 21 Mucositis studies recruiting now, 13 (62%) set no upper age limit and 7 (33%) stop at 75 or younger; 1 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 2
First in 2008; this study’s year is marked. 2 started in 2022.
This study's enrollment of 206 is above the median of 45 across 215 interventional studies indexed under Mucositis.
Median enrollment 55 across the 12 interventional studies, 60 across the 5 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 17 have an industry lead sponsor. The 10 most frequent:
Universidad Europea de Valencia is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Universidad Europea de Valencia has 2 studies filed under Mucositis — fewer than ten, so there is no comparison to draw.
1 of the studies in Mucositis with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05635929Mucosa Innovations, S.L.Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. | 2027-03 |
Among the 17 studies in Mucositis with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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
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
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 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
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.
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change From Baseline in Plaque Index (PI)
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.
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change From Baseline in Probing Depth (PD)
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.
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change From Baseline in Peri-Implant Crevicular Fluid (PICF) Volume
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.
Time frame: Baseline and 4-6 weeks
Change From Baseline in Matrix Metalloproteinase-8 (MMP-8) Levels
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.
Time frame: Baseline and 4-6 weeks
Plan to share: No — There is currently no established plan to share individual participant data
Ran from Jan 2022 to primary completion in Jun 2024, 28 months.
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 28 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 completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Europea de Valencia