Peri-implant MucositisNCT06287957
Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment: A Randomized Clinical
A study testing Labrida BioClean and EMS Handy 3.0 Perio Premium in people with Peri-implant Mucositis and Peri-Implantitis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis, Bleeding on Probing
- What is being tested?
- Labrida BioClean and EMS Handy 3.0 Perio Premium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 15 Feb 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Presence of peri-implant mucositis around at least one implant,
- Being over 18 years old,
- Being psychologically suitable,
- The teeth adjacent to the relevant implant are natural teeth,
- Having at least 1 implant in the maxillary or mandibular posterior region (teeth 4, 5, 6 and 7) and a cemented prosthesis that is not connected to other implants or teeth as its superstructure,
- Probing depth longer than 3 mm and shorter than 5 mm,
- Evidence of bleeding is required on probing.
Who cannot join
- Pregnancy
- History of chemotherapy and/or radiotherapy received in the past or currently being received,
- Bone loss around the implant,
- Presence of an implant in the area adjacent to the relevant implant,
- Dentures combined with other implants or teeth,
- Screw-retained prostheses
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Istanbul, Fatih, 34080
Alper Gultekin, Assistant Professor, +90 5326757236, alperg@istanbul.edu.tr
Kerem Bahceci, PhD Candidate, +90 5317132633, kerembhc@gmail.com
About this study
Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept.
Read the detailed description
Patients with single implants and single cemented crowns with peri-implant mucositis on their posterior teeth (Premolars and molars) Regular peri-implant mucositis treatment with air-abrasive device and a new method with labrida bioclean brush for cleaning the infection.
Experimental procedures and follow-ups Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept.
The number of cases to be taken in total, 12 cases, was determined as 48. There will be 54-55 cases with 10% drop out share.
GPOWER PROTOCOL F tests - ANOVA: Repeated measures, between factors Analysis: A priori: Compute required sample size Input: Effect size f = 0.4982302 α err prob = 0.05 Power (1-β err prob) = 0.95 Number of groups = 4 Number of measurements = 4 Corr among rep measures = 0.5 Output: Noncentrality parameter λ = 19.0643199 Critical F = 2.8164658 Numerator df = 3.0000000 Denominator df = 44.0000000 Total sample size = 48 Actual power = 0.9529658 For the results; Data will be analyzed with IBM SPSS V23. Repeated measures analysis of variance will be used to analyze quantitative data. For multiple comparisons, the Bonferroni test will be used. Analysis results will be presented as mean and standard deviation for quantitative data, and frequency and percentage for categorical data. The signifcance level will be taken as p<0.05.
Peri-implant mucositis is the last reversible stage before peri-implantitis. Treatment of the disease at this stage is very important. When treated, bone loss around the implant will be prevented and implant survival will be prolonged.
- Being tested
- Labrida BioClean, EMS Handy 3.0 Perio Premium
- Keywords
- peri-implant mucositis, Labrida Bioclean, Air-flow, Chitosan Brush, Peri-implantitis
- Medical subject headings
- Peri-Implantitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labrida BioCleanProcedure or surgery
Debriding the tissue around the implant with Labrida Bioclean
EMS Handy 3.0 Perio PremiumProcedure or surgery
Debriding the tissue around the implant with Air-Flow Device
| Study group | Role | What they receive |
|---|---|---|
| ML | Experimental | Patients with mini platform implants to be treated with Labrida Bioclean Receives: Procedure: Labrida BioClean |
| RL | Experimental | Patients with regular platform implants to be treated with Labrida Bioclean Receives: Procedure: Labrida BioClean |
| ME | Active comparator | Patients with mini platform implants to be treated with Air-Flow Devices (EMS Handy 3.0 Perio Premium) Receives: Procedure: EMS Handy 3.0 Perio Premium |
| RE | Active comparator | Patients with regular platform implants to be treated with Air-Flow Devices (EMS Handy 3.0 Perio Premium) Receives: Procedure: EMS Handy 3.0 Perio Premium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Probing depth will be recorded for all around the implant on each visit of the patient. One of the inclusion criterias is 3 to 5 mm probing depth around the implant.
Measured: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
Secondary outcomes (1)
Bleeding on Probing
Bleeding on probing will be recorded on each visit of the patient (No bleeding 0, spot bleeding 1, Linear Bleeding 2, Bleeding all around 3).
Measured: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are going to be 4 treatment groups. Group 1: Mini Implant Platform treated with Labrida Bioclean Group 2: Regular Implant Platform treated with Labrida Bioclean Group 3: Mini Implant Platform treated with Air-Flow Device Group 4: Regular Implant Platform treated with Air-Flow Device
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Gultekin, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287957
- Sponsor's protocol ID
- IU-DHF-AG-01
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 1 Mar 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment: A Randomized Clinical
- ClinicalTrials.gov ID
- NCT06287957
- Acronym / sponsor ID
- IU-DHF-AG-01
- Keywords
- peri-implant mucositis, Labrida Bioclean, Air-flow, Chitosan Brush, Peri-implantitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 1 Mar 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.
Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept.
Detailed description
Patients with single implants and single cemented crowns with peri-implant mucositis on their posterior teeth (Premolars and molars) Regular peri-implant mucositis treatment with air-abrasive device and a new method with labrida bioclean brush for cleaning the infection.
Experimental procedures and follow-ups Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept.
The number of cases to be taken in total, 12 cases, was determined as 48. There will be 54-55 cases with 10% drop out share.
GPOWER PROTOCOL F tests - ANOVA: Repeated measures, between factors Analysis: A priori: Compute required sample size Input: Effect size f = 0.4982302 α err prob = 0.05 Power (1-β err prob) = 0.95 Number of groups = 4 Number of measurements = 4 Corr among rep measures = 0.5 Output: Noncentrality parameter λ = 19.0643199 Critical F = 2.8164658 Numerator df = 3.0000000 Denominator df = 44.0000000 Total sample size = 48 Actual power = 0.9529658 For the results; Data will be analyzed with IBM SPSS V23. Repeated measures analysis of variance will be used to analyze quantitative data. For multiple comparisons, the Bonferroni test will be used. Analysis results will be presented as mean and standard deviation for quantitative data, and frequency and percentage for categorical data. The signifcance level will be taken as p<0.05.
Peri-implant mucositis is the last reversible stage before peri-implantitis. Treatment of the disease at this stage is very important. When treated, bone loss around the implant will be prevented and implant survival will be prolonged.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There are going to be 4 treatment groups. Group 1: Mini Implant Platform treated with Labrida Bioclean Group 2: Regular Implant Platform treated with Labrida Bioclean Group 3: Mini Implant Platform treated with Air-Flow Device Group 4: Regular Implant Platform treated with Air-Flow Device
| Arm | Type | Receives |
|---|---|---|
| ML | Experimental | Procedure: Labrida BioCleanPatients with mini platform implants to be treated with Labrida Bioclean |
| RL | Experimental | Procedure: Labrida BioCleanPatients with regular platform implants to be treated with Labrida Bioclean |
| ME | Active comparator | Procedure: EMS Handy 3.0 Perio PremiumPatients with mini platform implants to be treated with Air-Flow Devices (EMS Handy 3.0 Perio Premium) |
| RE | Active comparator | Procedure: EMS Handy 3.0 Perio PremiumPatients with regular platform implants to be treated with Air-Flow Devices (EMS Handy 3.0 Perio Premium) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of peri-implant mucositis around at least one implant,
- Being over 18 years old,
- Being psychologically suitable,
- The teeth adjacent to the relevant implant are natural teeth,
- Having at least 1 implant in the maxillary or mandibular posterior region (teeth 4, 5, 6 and 7) and a cemented prosthesis that is not connected to other implants or teeth as its superstructure,
Key exclusion criteria (7 listed)
- Pregnancy
- History of chemotherapy and/or radiotherapy received in the past or currently being received,
- Bone loss around the implant,
- Presence of an implant in the area adjacent to the relevant implant,
- Dentures combined with other implants or teeth,
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 |
|---|---|---|
| Labrida BioCleanDebriding the tissue around the implant with Labrida Bioclean | Procedure or surgery | ML, RL |
| EMS Handy 3.0 Perio PremiumDebriding the tissue around the implant with Air-Flow Device | Procedure or surgery | ME, RE |
Primary outcome
Probing Depth
Time frame: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
Probing depth will be recorded for all around the implant on each visit of the patient. One of the inclusion criterias is 3 to 5 mm probing depth around the implant.
1 secondary outcome
Bleeding on Probing
Time frame: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labrida BioClean and EMS Handy 3.0 Perio Premium in people with Peri-implant Mucositis and Peri-Implantitis, run by Istanbul 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 7 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: status not confirmed, as of the sponsor's last update on 1 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Depth (time frame: First visit, 2 weeks after the procedure, 4 weeks after the procedure, 8 weeks after the procedure). 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 1 Mar 2024.