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Comparison of Laser-Assisted and Conventional Non-Surgical Treatments for Improving Gum and Implant Health in Patients with Peri-Implantitis

A Randomized Controlled Clinical Trial Evaluating the Effects of Different Er, Cr: YSGG Laser Power Settings Adjunctive to Non-Surgical Periodontal Therapy on Clinical and Microbial Outcomes in Patients with Peri-Implantitis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000003370
Enrollment
50
Registered
2026-01-06
Start date
2026-01-12
Completion date
2026-02-06
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This clinical study will investigate how effective laser treatment is when used together with regular cleaning methods to treat inflammation and bone loss around dental implants (a condition called peri-implantitis). Fifty adults who have implants with gum and bone inflammation will take part. Participants will be divided into two groups. One group will receive only deep mechanical cleaning of the implant surfaces, and the other group will receive the same cleaning combined with a special type of laser treatment called Er,Cr:YSGG laser. The treatments will be carried out by a dentist at Trakya University Faculty of Dentistry in Türkiye. Clinical measurements such as gum depth, bleeding, plaque, and bone level will be checked before and after treatment, and again after three months. Microbiological tests will also be performed to identify the bacteria causing the infection. The study aims to find out whether adding laser treatment to routine mechanical cleaning can help reduce bacteria and improve gum health around dental implants more effectively.

Interventions

Before the intervention, all clinical and microbiological measurements were performed by a blinded and calibrated periodontist to establish baseline values. Arm 1 (Mechanical debridement + active Er,Cr:YSGG laser): Participants in this group then underwent the same mechanical debridement protocol as the control group using titanium curettes (Langer 1/2, 8 mm). Immediately after debridement, Er,Cr:YSGG laser irradiation (WaterLase iPlus™, Biolase Inc., Irvine, CA, USA) was applied to the peri-im

Before the intervention, all clinical and microbiological measurements were performed by a blinded and calibrated periodontist to establish baseline values. Arm 1 (Mechanical debridement + active Er,Cr:YSGG laser): Participants in this group then underwent the same mechanical debridement protocol as the control group using titanium curettes (Langer 1/2, 8 mm). Immediately after debridement, Er,Cr:YSGG laser irradiation (WaterLase iPlus™, Biolase Inc., Irvine, CA, USA) was applied to the peri-implant pocket. Laser parameters were set at a wavelength of 2780 nm, H mode (short pulse), power 1.5 W, frequency 30 Hz, pulse duration 140 µs, and 50% water and 40% air settings, using an RPFT5 fiber tip (14 mm, 1 mm spot size). The laser was applied in a bottom-up technique, starting from the base of the peri-implant pocket and moving coronally in parallel to the implant surface for approximately 30 seconds per site. The fiber tip was held at a 1 mm distance from the implant surface in non-contact mode. Patients were recalled on day 7 and day 14 for identical repeated applications. No antibiotics, antiseptic agents, or local anesthesia were used. The duration of each intervention session is approximately 30 minutes per participant, including pre-treatment hypersensitivity assessment (VAS and Schiff scores), tooth isolation and preparation, laser application according to the allocated power setting, and immediate post-treatment evaluation. Adherence to the intervention protocol will be monitored using a standardized operator checklist completed at each session (including laser parameters, treated tooth/teeth, number and duration of passes, and safety measures). All treatments will be performed by the same calibrated periodontist. In addition, laser log data (power setting, frequency, and application time) will be reviewed and noted periodically to confirm that the pre-specified parameters have been followed. After the treatment sessions, participants will be re-evaluated at the 3-month follow-up visit, during which clinical and microbiological measurements will be repeated by a blinded periodontist who also performed the baseline assessments. The clinical treatments, including mechanical debridement and laser applications, will be carried out by a different clinician who will remain unaware of the study hypotheses and be blinded to the group allocation. Laser parameters will be pre-set and calibrated by an independent researcher not involved in treatment or data evaluation. All procedures will take place at the Department of Periodontology, Faculty of Dentistry, Trakya University (Edirne, Türkiye). Both the treating clinician and participants will wear protective eyewear during laser procedures to ensure safety.

Sponsors

Trakya University Faculty of Dentistry, Department of Periodontology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Presence of at least one dental implant diagnosed with peri-implant mucositis or peri-implantitis based on clinical and radiographic findings. 2. Probing depth (PD) greater than 5 mm and bleeding and/or suppuration on probing around the affected implant. 3. Implants in function for at least one year after prosthetic loading. 4. At least one natural tooth present adjacent to the implant site. 5. Age greater than 18 years. 6. Good general health and ability to attend all follow-up visits. 7. Patients who provide written informed consent to participate.

Exclusion criteria

1. Systemic conditions that may affect bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis). 2. Use of antibiotics, anti-inflammatory drugs, or corticosteroids within the past 3 months. 3. History of radiotherapy or chemotherapy in the head and neck region. 4. Pregnancy or lactation. 5. Smoking or tobacco use in any form. 6. Parafunctional habits such as bruxism or clenching. 7. Implant mobility or prosthetic failure. 8. Use of antiseptic or antibiotic mouth rinses within the past 4 weeks. 9. Allergies or contraindications to Er,Cr:YSGG laser use (e.g., pacemaker, heart disease, bleeding disorders, respiratory disease, or hypersensitivity to local anesthetics). 10. Implants with severe bone loss (>50% of implant length) or where complete debridement access is not possible.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026