Toothbrush in the Genesis and Prevention of Dental Recessions (Recession)
Primary Purpose
Recession, Gingival
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
soft bristle toothbrush
mechanical toothbrush
Sponsored by
About this trial
This is an interventional prevention trial for Recession, Gingival
Eligibility Criteria
Inclusion Criteria: Age 18-60 years old; Fully dentate participants; Periodontal health Exclusion Criteria: Patient with periodontitis Previous ortho treatment Insufficient restorations or prostheses. Systemic disease affecting the periodontal tissues (e.g. bleeding disorders, diabetes mellitus etc.) Patients under medication associated with gingival enlargement (e.g. calcium channel blockers, immunosuppressants or anticonvulsants).
Sites / Locations
- PAD 4 ospedale san martino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Manual
Mechanical
Arm Description
Manual toothbrush
Mechanical toothbrush
Outcomes
Primary Outcome Measures
Change of Gengival recession from baseline to 6 months
gingival recession
Change of Gengival recession from baseline to 12 months
gingival recession
Secondary Outcome Measures
FMPS
full moth plaque score measured on 6 surfaces each tooth - percentage value
FMPS
full moth plaque score measured on 6 surfaces each tooth - percentage value
FMBS
full moth bleeding score measured on 6 surfaces each tooth - percentage value
FMBS
full moth bleeding score measured on 6 surfaces each tooth - percentage value
Full Information
NCT ID
NCT05949112
First Posted
June 27, 2023
Last Updated
July 13, 2023
Sponsor
Universita degli Studi di Genova
1. Study Identification
Unique Protocol Identification Number
NCT05949112
Brief Title
Toothbrush in the Genesis and Prevention of Dental Recessions
Acronym
Recession
Official Title
Efficacy of Manual or Mechanical Toothbrush in the Genesis and Prevention of Dental
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 27, 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita degli Studi di Genova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this research is to evaluate the effect of brushing on gingival recessions and to understand the impact of manual brushing and brushing with mechanical aid on their evolution.
The study involves the recruitment of 90 patients with or without gingival recessions at the Dentistry service of the University of Genoa.
The first phase involves the evaluation of the brushing force on the genesis of gingival recessions. A questionnaire will be filled out and the same toothbrushes and toothpastes will be provided for one month to 30 patients with recessions and 30 patients without recessions. After a month, the "wear" of the manual toothbrush and the gingival health indices will be measured.
In this phase 60 patients with recessions will be divided into two groups according to the oral hygiene method that will be recommended. In the first group a super soft toothbrush will be delivered, in the second group a mechanical toothbrush. Gingival health indices will be taken and an intraoral scan will be done to measure recessions. At 6 months and 12 months the indices will be measured again and compared between the two groups.
This research has two objectives:
Evaluate the differences in wear of the manual toothbrush head after one month of use between patients with gum recession and patients without gum recession. In the case of greater wear among patients with recessions it could be assumed that a greater brushing force is able to determine the formation of recessions.
Try to understand if there are differences between the super soft manual toothbrush and the mechanical toothbrush regarding the effectiveness of use and the "delicacy" on recession. Both tools are currently recommended for patients with recessions, but there are no studies in the literature comparing the two tools.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual
Arm Type
Experimental
Arm Description
Manual toothbrush
Arm Title
Mechanical
Arm Type
Experimental
Arm Description
Mechanical toothbrush
Intervention Type
Device
Intervention Name(s)
soft bristle toothbrush
Intervention Description
manual toothbrushes
Intervention Type
Device
Intervention Name(s)
mechanical toothbrush
Intervention Description
sonic toothbrush
Primary Outcome Measure Information:
Title
Change of Gengival recession from baseline to 6 months
Description
gingival recession
Time Frame
0-6 months
Title
Change of Gengival recession from baseline to 12 months
Description
gingival recession
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
FMPS
Description
full moth plaque score measured on 6 surfaces each tooth - percentage value
Time Frame
6 months
Title
FMPS
Description
full moth plaque score measured on 6 surfaces each tooth - percentage value
Time Frame
12 months
Title
FMBS
Description
full moth bleeding score measured on 6 surfaces each tooth - percentage value
Time Frame
6 months
Title
FMBS
Description
full moth bleeding score measured on 6 surfaces each tooth - percentage value
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-60 years old;
Fully dentate participants;
Periodontal health
Exclusion Criteria:
Patient with periodontitis
Previous ortho treatment
Insufficient restorations or prostheses.
Systemic disease affecting the periodontal tissues (e.g. bleeding disorders, diabetes mellitus etc.)
Patients under medication associated with gingival enlargement (e.g. calcium channel blockers, immunosuppressants or anticonvulsants).
Facility Information:
Facility Name
PAD 4 ospedale san martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Toothbrush in the Genesis and Prevention of Dental Recessions
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