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NCT Number: NCT07524153

Diode Laser and S100A8 in Peri-Implantitis

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kırıkkale University, Faculty of Dentistry

Kirikkale, Kırıkkale, 71100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in S100A8 levels in Peri-Implant Sulcular Fluid (PISF)

    Time frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)

    S100A8 levels will be measured using an ELISA kit (ng/mL) to evaluate the inflammatory response.

Secondary outcomes

  1. 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)

  2. 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)

  3. Modified Plaque Index (mPI)

    Time frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)

    Assessment of plaque accumulation on the implant/tooth surfaces. Unit of Measure: Score on a scale (0 to 3)

  4. Gingival Index (GI)

    Time frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)

    Assessment of gingival inflammation and bleeding tendency. Unit of Measure: Score on a scale (0 to 3)

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

Effect of 940 nm Diode Laser as an Adjunct to Mechanical Debridement on S100A8 Levels and Clinical Parameters in Peri-Implantitis Treatment

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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