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
| Registry | NCT07886593 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 206 (Actual) |
| Sponsor | Universidad Europea de Valencia (Other) |
| Conditions | Peri-implant Mucositis |
| Interventions | Conventional Non-Surgical Treatment, Adjunctive Diode Laser Therapy (Procedure, device) |
| Dates | start 2022-01-26, primary completion 2024-06-19, completion 2024-06-19, first posted 2026-10-21, last updated 2026-10-21 |
| Locations | 1 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Group | Active comparator | Procedure: Conventional Non-Surgical Treatment | 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. |
| Diode Laser Group | Experimental | Procedure: Conventional Non-Surgical Treatment; Device: Adjunctive Diode Laser Therapy | Participants received the same conventional non-surgical treatment as the control group plus adjunctive diode laser therapy using an 810-nm diode laser. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Universidad Europea de Valencia | Valencia, Valencia | Spain |