- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524153
Diode Laser and S100A8 in Peri-Implantitis
Effect of 940 nm Diode Laser as an Adjunct to Mechanical Debridement on S100A8 Levels and Clinical Parameters in Peri-Implantitis Treatment
Purpose: The aim of this study was to compare the effectiveness of diode laser and combined treatment protocols, applied in addition to mechanical debridement, in the treatment of peri-implantitis on clinical periodontal parameters and S100A8 levels in peri-implant sulcus fluid (PISF).
Methods: A total of 39 patients diagnosed with peri-implantitis were divided into three groups based on the treatment protocols used: Mechanical Debridement, Diode Laser, and Combined Treatment. Probing depth, clinical attachment level, modified plaque index, gingival index, and PISF volume measurements were recorded at baseline and at weeks 4 and 12. S100A8 levels in PISF samples were measured by ELISA.
Study Overview
Status
Conditions
Detailed Description
This study included 39 functional implants in patients aged 30-65 diagnosed with peri-implantitis (PD ≥6 mm, no clinical mobility). Participants were assigned to three groups (n=13 per group) using simple randomization (coin toss) performed by an independent researcher: Group 1 (Mechanical debridement only), Group 2 (940 nm diode laser monotherapy), and Group 3 (Combined mechanical debridement and diode laser). Exclusion criteria consisted of systemic diseases, smoking or alcohol consumption, pregnancy/lactation, parafunctional habits, and recent use of antibiotics (within 6 months) or peri-implant treatment (within 3 months). At baseline, clinical parameters were recorded and peri-implant sulcular fluid (PISF) samples were collected. Specifically, probing depth (PD) and clinical attachment level (CAL) were measured at 6 sites per implant, while the modified plaque index (mPI) and gingival index (GI) were assessed at 4 sites per implant.
Prior to PISF sampling, supragingival plaque was removed using sterile curettes, and the area was isolated and air-dried. Samples were collected from mesial and distal sites using paper strips (Ora Flow) inserted 1 mm into the sulcus for 30 seconds; contaminated strips were discarded. PISF volume was measured in microliters using a Periotron 8000 device, and samples were stored at -80°C until analysis. Treatment protocols included: mechanical debridement with titanium curettes for Group 1; decontamination using a 940 nm diode laser (2.5 W, CP2 mode, 400 μm fiber tip) for 30 seconds for Group 2; and a sequential combination of both treatments for Group 3. Following treatment, all pockets were irrigated with 10% povidone-iodine. Clinical parameters and PISF samples were evaluated at baseline (T0), week 4 (T1), and week 12 (T2). For biochemical analysis, S100A8 levels were determined via ELISA at 450 nm and calculated as ng/mL using a standard curve.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kırıkkale
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Kırıkkale, Kırıkkale, Turkey (Türkiye), 71100
- Kırıkkale University, Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals aged 30-65 years.
- Presence of at least one functional dental implant with no clinical mobility
- Diagnosis of peri-implantitis with a probing depth (PD) of ≥ 6 mm.
- Ability to provide informed consent and attend follow-up visits.
Exclusion Criteria:
- Systemic diseases that may interfere with wound healing (e.g., uncontrolled diabetes).
- History of radiation or chemotherapy.
- Pregnancy or lactation.
- Smoking or alcohol consumption.
- Parafunctional habits (e.g., bruxism).
- Use of systemic antibiotics within the last 6 months.
- Periodontal or peri-implant treatment in the relevant area within the last 3 months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Mechanical Debridement Group
13 participants.
Procedure: Subgingival mechanical debridement using sterile titanium curettes to remove biofilm and deposits from the implant surfaces.
Collection of PISF samples.
|
|
Diode Laser Monotherapy Group
13 participants.
Procedure: Decontamination using a 940 nm diode laser (2.5 W, CP2 mode) to remove biofilm from the implant surfaces.
Collection of PISF samples.
|
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Combined Group
13 participants.
Procedure: Sequential application of subgingival mechanical debridement followed by 940 nm diode laser decontamination.
Collection of PISF samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in S100A8 levels in Peri-Implant Sulcular Fluid (PISF)
Time Frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
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S100A8 levels will be measured using an ELISA kit (ng/mL) to evaluate the inflammatory response.
|
Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing Depth (PD)
Time Frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
|
Distance from the gingival margin to the bottom of the sulcus/pocket measured at six sites per implant/tooth. Unit of Measure: Millimeters (mm) |
Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
|
|
Clinical Attachment Level (CAL)
Time Frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
|
Distance from the cemento-enamel junction (CEJ) to the bottom of the pocket.Unit of Measure: Millimeters (mm)
|
Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
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|
Modified Plaque Index (mPI)
Time Frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
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Assessment of plaque accumulation on the implant/tooth surfaces.
Unit of Measure: Score on a scale (0 to 3)
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Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
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|
Gingival Index (GI)
Time Frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
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Assessment of gingival inflammation and bleeding tendency.
Unit of Measure: Score on a scale (0 to 3)
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Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Akif Nalbant, Specialist in Periodontology, Kirikkale University Faculty of Dentistry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.12.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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