Clinical trial NCT05949112: Toothbrush in the Genesis and Prevention of Dental Recessions
Official title: Efficacy of Manual or Mechanical Toothbrush in the Genesis and Prevention of Dental
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Recession, Gingival
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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).

Primary outcomes:
measure: Change of Gengival recession from baseline to 6 months
timeFrame: 0-6 months
measure: Change of Gengival recession from baseline to 12 months
timeFrame: 0-12 months
Secondary outcomes:
measure: FMPS
timeFrame: 6 months
measure: FMPS
timeFrame: 12 months
measure: FMBS
timeFrame: 6 months
measure: FMBS
timeFrame: 12 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: PAD 4 ospedale san martino
Study officials:
References: