Peri-implant MucositisNCT07886593
Diode Laser Added to Non-Surgical Treatment for Peri-Implant Mucositis
A study testing Conventional Non-Surgical Treatment and Adjunctive Diode Laser Therapy in people with Peri-implant Mucositis, run by Universidad Europea de Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Conventional Non-Surgical Treatment and Adjunctive Diode Laser Therapy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2022to 19 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Peri-implant Mucositis
- Being tested
- Conventional Non-Surgical Treatment, Adjunctive Diode Laser Therapy
- Keywords
- Peri-implant mucositis, Diode laser, Non-surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Non-Surgical TreatmentProcedure or surgery
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 TherapyDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Non-Surgical Treatment; Device: Adjunctive Diode Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start26 Jan 2022
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Arias-Herrera, Universidad Europea de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886593
- Sponsor's protocol ID
- UEV-PIM-DL-2022
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no established plan to share individual participant data
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.
PubMed 33282139Sanchez-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.
PubMed 31976039
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07886593
- Acronym / sponsor ID
- UEV-PIM-DL-2022
- Conditions
- Peri-implant Mucositis
- Keywords
- Peri-implant mucositis, Diode laser, Non-surgical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Universidad Europea de ValenciaUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: 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 Group | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Non-Surgical TreatmentMechanical 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. | Procedure or surgery | Control Group, Diode Laser Group |
| Adjunctive Diode Laser TherapyAlso: FOX III Diode Laser, 810-nm Diode LaserAdjunctive 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. | Device | Diode Laser Group |
Primary outcome
Change From Baseline in Bleeding on Probing (BOP)
Time frame: 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.
4 secondary outcomes
Change From Baseline in Plaque Index (PI)
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change From Baseline in Probing Depth (PD)
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change From Baseline in Peri-Implant Crevicular Fluid (PICF) Volume
Time frame: Baseline and 4-6 weeks
Change From Baseline in Matrix Metalloproteinase-8 (MMP-8) Levels
Time frame: Baseline and 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 33282139Sanchez-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.
- Background: PubMed 31976039Sanchez-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.
- Individual participant dataSharing planned: No. There is currently no established plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Non-Surgical Treatment and Adjunctive Diode Laser Therapy in people with Peri-implant Mucositis, run by Universidad Europea de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Bleeding on Probing (BOP) (time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07886593, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.