Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Nancy | OTHER |
Not provided
Not provided
Not provided
Not provided
Because of the difficulties of disorganizing the dental biofilm in these adolescents with fixed orthodontic treatment, electric toothbrushes have been proposed as an alternative to manual toothbrushes. Electric toothbrushes, available in a wide range of price points, have been developed with the goal of replicating the complex motions required by the manual toothbrush and making plaque removal more efficient. However, the overall effect size is limited, and the clinical relevance is not yet clear. Applied to orthodontics, specialized manual toothbrushes have also recently been developed. Few recent clinical trials have been conducted in patients with orthodontic appliances.
Thus, the question of whether and which type of manual or electric toothbrushes may be beneficial for patients with orthodontic appliances is still unresolved. Given the variety of toothbrushes available on the market, there is a need for sound clinical research to evaluate their effectiveness to guide professional recommendations. This work will provide a significant advance in the knowledge of the potential of the latest generation of electric toothbrushes on gingival inflammation, potentially reducing the risk of caries and gingival lesions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group using sonic toothbrush | Experimental | Patients will be asked to use a sonic toothbrush for 24 months |
|
| Group using hydrosonic toothbrush | Experimental | Patients will be asked to use a hydrosonic toothbrush for 24 months |
|
| Group using manual toothbrush | Placebo Comparator | Patients will be asked to use a manual toothbrush for 24 months |
|
| Group using manual toothbrush with 5460 strands | Experimental | Patients will be asked to use a manual toothbrush with 5460 strands for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonicare Diamond Clean 9000 | Device | Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gingival bleeding from baseline during orthodontic treatment | Change of gingival inflammation in patients with fixed orthodontic appliances using manual or electric toothbrushes in daily practice | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Questionnaire to assess the acceptability of oral hygiene products by patients | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Effect on gingival inflammation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence Carrouel, PhD | Contact | 0478785745 | +33 | florence.carrouel@univ-lyon1.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de soin dentaire | Recruiting | Nancy | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Parallel Assignment This trial is designed as an four-arm parallel cluster randomized controlled trial and an allocation ratio of 1:1:1:1
Not provided
Not provided
Not provided
| HydroSonic Pro | Device | Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment |
|
| Oral-B 123 | Device | Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment |
|
| Curaprox CS 5460 | Device | Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment |
|
gingival index |
| T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Effect on gingival bleeding | Bleeding on Probing | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Effect on dental plaque | plaque index | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Effect on gingival tissue | micro-osteoperforation | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Effect on gingival attachment | clinical attachment loss | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Enamel lesions | Assess the incidence of initial enamel lesions | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Dentinal hypersensitivity | Assess the incidence of dentinal hypersensitivity | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |
| Salivary acidity | Measure of pH | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) |