NCT06800625

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 22, 2025

Last Update Submit

January 28, 2025

Conditions

Keywords

BiofilmDental İmplantPeri-implant mucositisToothbrushing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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 (-).

    baseline, 3rd-month, 6th-month and 9th-month

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigde Omer Halisdemir University, Dentistry Faculty, Periodontology Department

Niğde, Niğde Province, 06800, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asist. prof

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 30, 2025

Study Start

April 15, 2023

Primary Completion

May 15, 2024

Study Completion

June 15, 2024

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations