- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800625
Manual Versus Sonic-powered Toothbrushing for Plaque Reduction in Patients with Peri-implant Mucositis
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Niğde, Turkey, 06800
- Nigde Omer Halisdemir University, Dentistry Faculty, Periodontology Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1.gruop: Manuel toothbrusing
Patients with peri-implant mucositis were instructed to use manuel toothbrushing for plaque reduction.
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2. group: sonic-powered toothbrushing
Patients with peri-implant mucositis were instructed to use sonic-powered toothbrushing for plaque reduction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Gingival İndex (MGI)
Time Frame: baseline, 3rd-month, 6th-month and 9th-month
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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. |
baseline, 3rd-month, 6th-month and 9th-month
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Modified plaque index (MPI)
Time Frame: baseline, 3rd-month, 6th-month and 9th-month
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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 (-). |
baseline, 3rd-month, 6th-month and 9th-month
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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