Clinical Trials Directory

Trials / Completed

CompletedNCT07524153

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

Status
Completed
Phase
Study type
Observational
Enrollment
39 (actual)
Sponsor
Kırıkkale University · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Timeline

Start date
2025-01-01
Primary completion
2025-06-01
Completion
2025-10-10
First posted
2026-04-13
Last updated
2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07524153. Inclusion in this directory is not an endorsement.