Toothbrush in the Genesis and Prevention of Dental Recessions

Recession, Gingival Clinical Trial

— Recession  

Official title:

Efficacy of Manual or Mechanical Toothbrush in the Genesis and Prevention of Dental

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05949112
• Other study ID #: Recession1
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

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