Peri-implantitisNCT06685523
Evaluation of Fractalkine and Its Receptor in Peri-implantitis
A study testing Subgingival debridement, Er:YAG laser decontamination and Diyot laser decontamination in people with Peri-implantitis, run by Kubilay BARIŞ at 1 site in Turkey (Türkiye).
Trial summary
In this study, mechanical debridement group, Er:YAG laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Subgingival debridement, Er:YAG laser decontamination and Diyot laser decontamination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Probing depth of 4-6 mm, bone loss of at least 2 mm on X-ray and presence of inflammatory symptoms in soft tissue
- No systemic disease that may affect the outcome of the treatment
- Patients with healthy periodontium or patients with completed periodontal treatment
- Individuals at least 6 months after prosthesis loading on the implant
- Individuals who do not require further surgery for the treatment of peri-implantitis
- Implants with at least 2 mm keratised gingiva
- Individuals aged 40-60 years
Who cannot join
- Individuals undergoing radiation therapy
- Individuals who smoke and drink alcohol
- Individuals in pregnancy or lactation
- Individuals who have received antibiotic treatment in the last three months
- Individuals with parafunctional habits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırıkkale University, Faculty of Dentistry, Department of Periodontology
Kirikkale, 71000
Musa Bulut, Staff, +90-552-784-71-00, lokipow452@gmail.com
About this study
Official title: Evaluation of Fractalkine and Its Receptor in the Non-Surgical Treatment of Peri-implantitis
In this study, mechanical debridement group, Er:YAG laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis.
- Conditions
- Peri-implantitis
- Being tested
- Subgingival debridement, Er:YAG laser decontamination, Diyot laser decontamination
- Keywords
- Er:YAG laser, Debridment, peri-implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival debridementProcedure or surgery
To be applied 1 times (0. days)
Er:YAG laser decontaminationProcedure or surgery
To be applied 3 times
Diyot laser decontaminationProcedure or surgery
To be applied 3 times
| Study group | Role | What they receive |
|---|---|---|
| Group healty | No intervention | Not described |
| Mechanical debridement group | Experimental | Not described Receives: Procedure: Subgingival debridement |
| Er:YAG laser applied group | Experimental | Not described Receives: Procedure: Er:YAG laser decontamination |
| Diyot laser applied group | Experimental | Not described Receives: Procedure: Diyot laser decontamination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth, clinical attachment loss
Measurement will be made with a periodontal probe. The unit of measurement is millimetre. The primary outcome measures are interrelated.
Measured: sixth month
Secondary outcomes (1)
gingival index, plaque index, sulcus blood index
The 0,1,2,3 point system for index measurements is currently used in periodontology. These scores will be used in secondary outcome measures.
Measured: sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start8 Nov 2024
- Primary completion8 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four group: * Peri-implant healty * Mechanical curette * Er:YAG laser * Diyot laser
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kubilay BARIŞ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubilay BARIŞ, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685523
- Sponsor's protocol ID
- KU-DHF-KB-01
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fractalkine and Its Receptor in the Non-Surgical Treatment of Peri-implantitis
- ClinicalTrials.gov ID
- NCT06685523
- Acronym / sponsor ID
- KU-DHF-KB-01
- Conditions
- Peri-implantitis
- Keywords
- Er:YAG laser, Debridment, peri-implantitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kubilay BARIŞUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 8 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
In this study, mechanical debridement group, Er:YAG laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Four group: * Peri-implant healty * Mechanical curette * Er:YAG laser * Diyot laser
| Arm | Type | Receives |
|---|---|---|
| Group healty | No intervention | – |
| Mechanical debridement group | Experimental | Procedure: Subgingival debridement |
| Er:YAG laser applied group | Experimental | Procedure: Er:YAG laser decontamination |
| Diyot laser applied group | Experimental | Procedure: Diyot laser decontamination |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Probing depth of 4-6 mm, bone loss of at least 2 mm on X-ray and presence of inflammatory symptoms in soft tissue
- No systemic disease that may affect the outcome of the treatment
- Patients with healthy periodontium or patients with completed periodontal treatment
- Individuals at least 6 months after prosthesis loading on the implant
- Individuals who do not require further surgery for the treatment of peri-implantitis
Key exclusion criteria (5 listed)
- Individuals undergoing radiation therapy
- Individuals who smoke and drink alcohol
- Individuals in pregnancy or lactation
- Individuals who have received antibiotic treatment in the last three months
- Individuals with parafunctional habits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subgingival debridementTo be applied 1 times (0. days) | Procedure or surgery | Mechanical debridement group |
| Er:YAG laser decontaminationTo be applied 3 times | Procedure or surgery | Er:YAG laser applied group |
| Diyot laser decontaminationTo be applied 3 times | Procedure or surgery | Diyot laser applied group |
Primary outcome
Probing depth, clinical attachment loss
Time frame: sixth month
Measurement will be made with a periodontal probe. The unit of measurement is millimetre. The primary outcome measures are interrelated.
1 secondary outcome
gingival index, plaque index, sulcus blood index
Time frame: sixth month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subgingival debridement, Er:YAG laser decontamination and Diyot laser decontamination in people with Peri-implantitis, run by Kubilay BARIŞ 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubilay Barış, Dr. (+90-0553-973-64-77, kubilaybaris60@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth, clinical attachment loss (time frame: sixth month). 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 12 Nov 2024.