Toothbrush in the Genesis and Prevention of Dental Recessions (Recession)

• ClinicalTrials.gov Identifier: NCT05949112
• Recruitment Status: Not yet recruiting
• First Posted: July 17, 2023
• Last Update Posted: July 17, 2023
• Sponsor: Universita degli Studi di Genova
• Information provided by (Responsible Party): Paolo Pesce, Universita degli Studi di Genova

Tracking Information

• First Submitted Date: June 27, 2023
• First Posted Date: July 17, 2023
• Last Update Posted Date: July 17, 2023
• Estimated Study Start Date: July 27, 2023
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2023)

• Change of Gengival recession from baseline to 6 months [ Time Frame: 0-6 months ]
  gingival recession
• Change of Gengival recession from baseline to 12 months [ Time Frame: 0-12 months ]
  gingival recession

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 13, 2023)

• FMPS [ Time Frame: 6 months ]
  full moth plaque score measured on 6 surfaces each tooth - percentage value
• FMPS [ Time Frame: 12 months ]
  full moth plaque score measured on 6 surfaces each tooth - percentage value
• FMBS [ Time Frame: 6 months ]
  full moth bleeding score measured on 6 surfaces each tooth - percentage value
• FMBS [ Time Frame: 12 months ]
  full moth bleeding score measured on 6 surfaces each tooth - percentage value

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Toothbrush in the Genesis and Prevention of Dental Recessions
• Official Title: Efficacy of Manual or Mechanical Toothbrush in the Genesis and Prevention of Dental

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:

1. 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.
2. 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Recession, Gingival

Intervention

• Device: soft bristle toothbrush
  manual toothbrushes
• Device: mechanical toothbrush
  sonic toothbrush

Study Arms

• Experimental: Manual
  Manual toothbrush
  Intervention: Device: soft bristle toothbrush
• Experimental: Mechanical
  Mechanical toothbrush
  Intervention: Device: mechanical toothbrush

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 13, 2023): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2025
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT05949112
• Other Study ID Numbers: Recession1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Paolo Pesce, Universita degli Studi di Genova
• Original Responsible Party: Same as current
• Current Study Sponsor: Universita degli Studi di Genova
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universita degli Studi di Genova
• Verification Date: July 2023