ToothbrushingNCT06800625
Manual Versus Sonic-powered Toothbrushing for Plaque Reduction in Patients with Peri-implant Mucositis
An observational study of Toothbrushing and Periimplant Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Aim: To compare the effect of manual and sonic-powered toothbrushing on biofilm control in patients with peri-implant mucositis. Materials and methods: The study was completed with a total of 41 patients, 21 in the sonic tooth brushing group and 20 in the manual tooth brushing group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toothbrushing, Periimplant Diseases
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who applied to Niğde Ömer Halisdemir University Faculty of Dentistry Periodontics Clinic between 15.04.2023 and 15.06.2023 for the control of dental implants and/or periodontal treatment, volunteered to participate in the study and met the following criteria were included in the study. Written consent was obtained from volunteer patients for the research.
Who may be able to join
- Bleeding on probing around the implant
- No bone loss around the implant in the radiograph
- Having adequate keratinized gingiva around the implant
- The presence of an implant prosthesis that was installed at least three months previously
- No systemic disease
- no smoke
- No use of antibiotic medications within the previous three months
Who cannot join
- Patients with missing data and who do not allow data use
- Smoker
- Data from pregnant and lactating patients
- Pocket depth around the implant is ≥ 5
- Patients with peri-implantitis (bone loss around the implant)
- Patients with insufficient attached gingiva around the implant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigde Omer Halisdemir University, Dentistry Faculty, Periodontology Department
Niğde, Niğde Province, 06800
About this study
Official title: Manual Versus Sonic-powered Toothbrushing for Plaque Reduction in Patients with Peri-implant Mucositis: Randomized Controlled Trial.
Aim: To compare the effect of manual and sonic-powered toothbrushing on biofilm control in patients with peri-implant mucositis.
Materials and methods: The study was completed with a total of 41 patients, 21 in the sonic tooth brushing group and 20 in the manual tooth brushing group. The patients' baseline, 3rd-month, 6th-month and 9th-month periodontal examination data (Modified Gingival İndex (MGI), Modified plaque index (MPI), Bleeding on the probing index (BOP), Pocket depth (PD), Gingival Recession (GR) and Gingival Biotype (GB)) were analyzed.
- Conditions
- Toothbrushing, Periimplant Diseases
- Keywords
- Biofilm, Dental İmplant, Peri-implant mucositis, Toothbrushing
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 |
|---|---|---|
| 1.gruop: Manuel toothbrusing | Patients with peri-implant mucositis were instructed to use manuel toothbrushing for plaque reduction. | |
| 2. group: sonic-powered toothbrushing | Patients with peri-implant mucositis were instructed to use sonic-powered toothbrushing for plaque reduction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Gingival İndex (MGI)
In order to determine the degree of inflammation in the surrounding soft tissue of the implants, mGI score is obtained from four regions: mesial, distal, buccal and palatal. The mGI score for each implant is determined by adding the values and dividing by 4.
Scoring is done as follows; 0: No bleeding when probing around the implant with a periodontal probe l: There is a point isolated bleeding on probing. 2: On probing, there is bleeding forming a red line along the mucosal margin. 3: There is intense bleeding on probing.
Measured: baseline, 3rd-month, 6th-month and 9th-month
Modified plaque index (MPI)
This index, which is used to determine the surface cleanliness of implants, is measured from 4 regions of the implants: mesial, distal, buccal and palatal, taking into account the following criteria. The mPI score for each implant is determined by adding the obtained values and dividing by 4.
Scoring is done as follows; 0: No record. l: Presence of plaque in the implant sulcus that can be detected with the probe tip. If there is a roughened implant surface in this area, at least "1" value is given.
2: Presence of visible plaque. 3: Presence of soft attachment on the implant surface c. Bleeding on Probing Index (BOP) Approximately 20 seconds after moving the periodontal probe inside the periodontal pocket, it is evaluated whether there is bleeding. If there is bleeding, the score of that area is recorded as (+), otherwise it is recorded as (-).
Measured: baseline, 3rd-month, 6th-month and 9th-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start15 Apr 2023
- Primary completion15 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToothbrushingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Niğde Ömer Halisdemir University
- Responsible party
- Principal investigator, Selcen Ozcan Bulut, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800625
- Sponsor's protocol ID
- 2023/15
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 30 Jan 2025
- 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Versus Sonic-powered Toothbrushing for Plaque Reduction in Patients with Peri-implant Mucositis: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06800625
- Acronym / sponsor ID
- 2023/15
- Conditions
- Toothbrushing, Periimplant Diseases
- Keywords
- Biofilm, Dental İmplant, Peri-implant mucositis, Toothbrushing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Niğde Ömer Halisdemir University
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Jan 2025 (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.
Aim: To compare the effect of manual and sonic-powered toothbrushing on biofilm control in patients with peri-implant mucositis.
Materials and methods: The study was completed with a total of 41 patients, 21 in the sonic tooth brushing group and 20 in the manual tooth brushing group. The patients' baseline, 3rd-month, 6th-month and 9th-month periodontal examination data (Modified Gingival İndex (MGI), Modified plaque index (MPI), Bleeding on the probing index (BOP), Pocket depth (PD), Gingival Recession (GR) and Gingival Biotype (GB)) were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.gruop: Manuel toothbrusing | – | –Patients with peri-implant mucositis were instructed to use manuel toothbrushing for plaque reduction. |
| 2. group: sonic-powered toothbrushing | – | –Patients with peri-implant mucositis were instructed to use sonic-powered toothbrushing for plaque reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to Niğde Ömer Halisdemir University Faculty of Dentistry Periodontics Clinic between 15.04.2023 and 15.06.2023 for the control of dental implants and/or periodontal treatment, volunteered to participate in the study and met the following criteria were included in the study. Written consent was obtained from volunteer patients for the research.
Key inclusion criteria (7 listed)
- Bleeding on probing around the implant
- No bone loss around the implant in the radiograph
- Having adequate keratinized gingiva around the implant
- The presence of an implant prosthesis that was installed at least three months previously
- No systemic disease
Key exclusion criteria (6 listed)
- Patients with missing data and who do not allow data use
- Smoker
- Data from pregnant and lactating patients
- Pocket depth around the implant is ≥ 5
- Patients with peri-implantitis (bone loss around the implant)
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
Modified Gingival İndex (MGI)
Time frame: baseline, 3rd-month, 6th-month and 9th-month
In order to determine the degree of inflammation in the surrounding soft tissue of the implants, mGI score is obtained from four regions: mesial, distal, buccal and palatal. The mGI score for each implant is determined by adding the values and dividing by 4. Scoring is done as follows; 0: No bleeding when probing around the implant with a periodontal probe l: There is a point isolated bleeding on probing. 2: On probing, there is bleeding forming a red line along the mucosal margin. 3: There is intense bleeding on probing.
Modified plaque index (MPI)
Time frame: baseline, 3rd-month, 6th-month and 9th-month
This index, which is used to determine the surface cleanliness of implants, is measured from 4 regions of the implants: mesial, distal, buccal and palatal, taking into account the following criteria. The mPI score for each implant is determined by adding the obtained values and dividing by 4. Scoring is done as follows; 0: No record. l: Presence of plaque in the implant sulcus that can be detected with the probe tip. If there is a roughened implant surface in this area, at least "1" value is given. 2: Presence of visible plaque. 3: Presence of soft attachment on the implant surface c. Bleeding on Probing Index (BOP) Approximately 20 seconds after moving the periodontal probe inside the periodontal pocket, it is evaluated whether there is bleeding. If there is bleeding, the score of that area is recorded as (+), otherwise it is recorded as (-).
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 30 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Toothbrushing and Periimplant Diseases, run by Hacettepe 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 6 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 30 Jan 2025. 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?
Modified Gingival İndex (MGI) (time frame: baseline, 3rd-month, 6th-month and 9th-month). The study lists 2 primary outcomes in all. 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 30 Jan 2025.