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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recession, Gingival Device: soft bristle toothbrush Device: mechanical toothbrush Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Manual or Mechanical Toothbrush in the Genesis and Prevention of Dental
Estimated Study Start Date : July 27, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Manual
Manual toothbrush
 Device: soft bristle toothbrush
manual toothbrushes
Experimental: Mechanical
Mechanical toothbrush
 Device: mechanical toothbrush
sonic toothbrush


Outcome Measures
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Primary Outcome Measures :
  1. Change of Gengival recession from baseline to 6 months [ Time Frame: 0-6 months ]
    gingival recession

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


Secondary Outcome Measures :
  1. FMPS [ Time Frame: 6 months ]
    full moth plaque score measured on 6 surfaces each tooth - percentage value

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

  3. FMBS [ Time Frame: 6 months ]
    full moth bleeding score measured on 6 surfaces each tooth - percentage value

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05949112


Locations
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Italy
PAD 4 ospedale san martino
Genova, Italy, 16132
Sponsors and Collaborators
Universita degli Studi di Genova
More Information
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Responsible Party: Paolo Pesce, Prof, Universita degli Studi di Genova
ClinicalTrials.gov Identifier: NCT05949112    
Other Study ID Numbers: Recession1
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy