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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recession, Gingival
• Intervention / Treatment: Device: soft bristle toothbrush; Device: mechanical toothbrush

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16132
    • PAD 4 ospedale san martino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual; Manual toothbrush	Device: soft bristle toothbrush; manual toothbrushes
Experimental: Mechanical; Mechanical toothbrush	Device: mechanical toothbrush; sonic toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Gengival recession from baseline to 6 months	gingival recession	0-6 months
Change of Gengival recession from baseline to 12 months	gingival recession	0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMPS	full moth plaque score measured on 6 surfaces each tooth - percentage value	6 months
FMPS	full moth plaque score measured on 6 surfaces each tooth - percentage value	12 months
FMBS	full moth bleeding score measured on 6 surfaces each tooth - percentage value	6 months
FMBS	full moth bleeding score measured on 6 surfaces each tooth - percentage value	12 months

Collaborators and Investigators

• Sponsor: Universita degli Studi di Genova

Study record dates

Study Major Dates

• Study Start (Estimated): July 27, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Recession1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No