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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05949112
Other study ID # Recession1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 27, 2023
Est. completion date September 2025

Study information

Verified date July 2023
Source Universita degli Studi di Genova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date September 2025
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
soft bristle toothbrush
manual toothbrushes
mechanical toothbrush
sonic toothbrush

Locations

Country Name City State
Italy PAD 4 ospedale san martino Genova

Sponsors (1)

Lead Sponsor Collaborator
Universita degli Studi di Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Gengival recession from baseline to 6 months gingival recession 0-6 months
Primary Change of Gengival recession from baseline to 12 months gingival recession 0-12 months
Secondary FMPS full moth plaque score measured on 6 surfaces each tooth - percentage value 6 months
Secondary FMPS full moth plaque score measured on 6 surfaces each tooth - percentage value 12 months
Secondary FMBS full moth bleeding score measured on 6 surfaces each tooth - percentage value 6 months
Secondary FMBS full moth bleeding score measured on 6 surfaces each tooth - percentage value 12 months
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