Peri-implant MucositisNCT07895667
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
A study testing Conventional Non-Surgical Treatment and FOX III Diode Laser Therapy in people with Peri-implant Mucositis, run by Universidad Europea de Valencia.
Trial summary
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. 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 FOX III 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
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- Diagnosis of peri-implant mucositis according to the criteria established by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
- Presence of at least one eligible dental implant meeting all of the following criteria:
- 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.
Who cannot join
- Systemic diseases capable of altering the immune response.
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs).
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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
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.
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 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.
- Conditions
- Peri-implant Mucositis
- Being tested
- Conventional Non-Surgical Treatment, FOX III Diode Laser Therapy
- Keywords
- Peri-Implant Mucositis, Peri-Implant Disease, Diode Laser, Laser Therapy, Mechanical Debridement, Non-Surgical Treatment, Bleeding on Probing, Matrix Metalloproteinase-8
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 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.
FOX III Diode Laser TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Procedure: Conventional Non-Surgical Treatment |
| Diode Laser Group | Experimental | 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. Receives: Procedure: Conventional Non-Surgical Treatment; Device: FOX III Diode Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
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 posted26 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Participants with peri-implant mucositis will be randomly allocated in a 1:1 ratio to either conventional non-surgical mechanical treatment alone or conventional non-surgical mechanical treatment combined with adjunctive diode laser therapy.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
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
- NCT07895667
- Sponsor's protocol ID
- CIPI/21/88
- Other IDs
- 19/521-R_P Tesis
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 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
- NCT07895667
- Acronym / sponsor ID
- CIPI/21/88
- Conditions
- Peri-implant Mucositis
- Keywords
- Peri-Implant Mucositis, Peri-Implant Disease, Diode Laser, Laser Therapy, Mechanical Debridement, Non-Surgical Treatment, Bleeding on Probing, Matrix Metalloproteinase-8
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Universidad Europea de ValenciaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 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.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with peri-implant mucositis will be randomly allocated in a 1:1 ratio to either conventional non-surgical mechanical treatment alone or conventional non-surgical mechanical treatment combined with adjunctive diode laser therapy.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Conventional Non-Surgical TreatmentParticipants 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. |
| Diode Laser Group | Experimental | Procedure: Conventional Non-Surgical Treatment, Device: FOX III Diode Laser TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Diagnosis of peri-implant mucositis according to the criteria established by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
- Presence of at least one eligible dental implant meeting all of the following criteria:
- 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.
Key exclusion criteria (7 listed)
- Systemic diseases capable of altering the immune response.
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs).
- 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 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. | Procedure or surgery | Control Group, Diode Laser Group |
| FOX III Diode Laser TherapyAdjunctive 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. | Device | Diode Laser Group |
Primary outcome
Change in Bleeding on Probing (BOP)
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
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.
4 secondary outcomes
Change in Probing Depth (PD)
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Plaque Index (PI)
Time frame: Baseline, 4-6 weeks, 3 months, 6 months, and 12 months
Change in Peri-Implant Crevicular Fluid (PICF) Volume
Time frame: Baseline and 4-6 weeks
Change in Matrix Metalloproteinase-8 (MMP-8) Levels
Time frame: Baseline and 4-6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Non-Surgical Treatment and FOX III Diode Laser Therapy in people with Peri-implant Mucositis, run by Universidad Europea de Valencia.
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 4 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebeca Sánchez-Martos, DDS, PhD (+34 960453766, rebeca.sanchez@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change 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?
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 26 Oct 2026.