Toothbrush in the Genesis and Prevention of Dental Recessions

NCT05949112 | Unknown

• 1 other identifier: Recession1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Recession, Gingival

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• FMPS

  6 months

• FMPS

  12 months

• FMBS

  6 months

• FMBS

  12 months

Study Arms (2)

Manual

EXPERIMENTAL

Manual toothbrush

Device: soft bristle toothbrush

Mechanical

EXPERIMENTAL

Mechanical toothbrush

Device: mechanical toothbrush

Interventions

soft bristle toothbrush DEVICE

manual toothbrushes

Manual

mechanical toothbrush DEVICE

sonic toothbrush

Mechanical

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-60 years old;
• Fully dentate participants;
• Periodontal health

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universita degli Studi di Genova: lead

Study Sites (1)

PAD 4 ospedale san martino

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 17, 2023
• Study Start: July 27, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

IT (1)