Periimplant DiseasesNCT07524153
Diode Laser and S100A8 in Peri-Implantitis
An observational study of Periimplant Diseases and S100A8, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periimplant Diseases, S100A8, Biomarkers
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 10 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University, Faculty of Dentistry
Kirikkale, Kırıkkale, 71100
About this study
Official title: 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.
Read the 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
- Periimplant Diseases, S100A8, Biomarkers, Calprotectin
- Keywords
- calprotectin, biomarkers, inflammation, Peri-implantitis
- Medical subject headings
- Inflammation, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
Secondary outcomes (4)
Probing Depth (PD)
Distance from the gingival margin to the bottom of the sulcus/pocket measured at six sites per implant/tooth.
Unit of Measure: Millimeters (mm)
Measured: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
Clinical Attachment Level (CAL)
Distance from the cemento-enamel junction (CEJ) to the bottom of the pocket.Unit of Measure: Millimeters (mm)
Measured: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
Modified Plaque Index (mPI)
Assessment of plaque accumulation on the implant/tooth surfaces. Unit of Measure: Score on a scale (0 to 3)
Measured: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
Gingival Index (GI)
Assessment of gingival inflammation and bleeding tendency. Unit of Measure: Score on a scale (0 to 3)
Measured: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periimplant DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akif Nalbant, Kırıkkale University
- Investigators
- Akif Nalbant, Specialist in Periodontology, Principal investigator, Kirikkale University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524153
- Sponsor's protocol ID
- 2024.12.21
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 940 nm Diode Laser as an Adjunct to Mechanical Debridement on S100A8 Levels and Clinical Parameters in Peri-Implantitis Treatment
- ClinicalTrials.gov ID
- NCT07524153
- Acronym / sponsor ID
- 2024.12.21
- Conditions
- Periimplant Diseases, S100A8, Biomarkers, Calprotectin
- Keywords
- calprotectin, biomarkers, inflammation, Peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Probing Depth (PD)
Time frame: 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)
Modified Plaque Index (mPI)
Time frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
Gingival Index (GI)
Time frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Periimplant Diseases
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Markers of Bone Destruction and Oxidative Stress in Peri-implantitis
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Not yet recruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akif Nalbant, Specialist in Periodontology principal investigator
Kirikkale University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periimplant Diseases and S100A8, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in S100A8 levels in Peri-Implant Sulcular Fluid (PISF) (time frame: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.