NCT07524153

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 1, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

calprotectinbiomarkersinflammationPeri-implantitis

Outcome Measures

Primary Outcomes (1)

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

    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)

Secondary Outcomes (4)

  • Probing Depth (PD)

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

  • Clinical Attachment Level (CAL)

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

  • Modified Plaque Index (mPI)

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

  • Gingival Index (GI)

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

Study Arms (3)

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.

Combined Group

13 participants. Procedure: Sequential application of subgingival mechanical debridement followed by 940 nm diode laser decontamination. Collection of PISF samples.

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of systemically healthy, non-smoking individuals aged 30-65 years who have at least one functional dental implant diagnosed with peri-implantitis (probing depth ≥ 6 mm, no clinical mobility). Participants are selected from patients admitted to the Kırıkkale University Faculty of Dentistry, Department of Periodontology for routine follow-up or treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University, Faculty of Dentistry

Kırıkkale, Kırıkkale, 71100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

InflammationPeri-Implantitis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Akif Nalbant, Specialist in Periodontology

    Kirikkale University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 13, 2026

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

October 10, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations