Orthodontic Appliance Clinical Trial
— MAHOOfficial title:
Comparison of the Effectiveness of 3 Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients: Prospective Randomized Controlled Clinical Study
Orthodontic appliances have been shown to interfere with oral hygiene maneuvers by providing many additional sites for formation and retention of biofilm. Its accumulation is responsible for undesirable effects such as decays and periodontal pathologies. These lower the benefit / risk ratio of orthodontic treatments. In addition, their management is not negligible at the macroeconomic level. As such, it is more than necessary for the orthodontist to teach oral hygiene methods adapted to each of his patients fitted to limit the risk of appearance of biofilm.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | January 29, 2025 |
Est. primary completion date | January 29, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility | Inclusion Criteria: - Patient aged 11 to 17 * years; - Patient with stable adolescent teeth, young adult or adult teeth; - Requiring a fixed orthodontic treatment without extraction (other than wisdom teeth) at least to the maxillary arch; - Affiliated, himself or through his parents to a social security scheme; - Having received information on the protocol and having given free, informed and written consent. - Whose holders of parental authority have received information on the protocol and have given free, informed and written consent. - Aged under 18 at the end of the 6 months of participation Exclusion Criteria: - Patient with periodontal disease or progressive carious lesions; - Patient with a prosthetic crown or composite restoration on the central and / or lateral maxillary incisor; - Patient with systemic disease, major syndrome or cleft palate; - Patient with an abnormal dental structure (eg fluorosis, MIH, imperfect amelogenesis, etc.); - Patients taking long-term medication influencing periodontal health (corticosteroids, anti-epileptics, etc.); - Patient with a physical or mental handicap preventing him from carrying out oral hygiene maneuvers independently; - Patient refusing to use the products and instruments prescribed for the study; - Patients with dental agenesis; - Patients with poor command of the French language - Patient deprived of liberty by judicial or administrative decision or subject to a legal protection measure; - Pregnant patient; - Smoking patient. |
Country | Name | City | State |
---|---|---|---|
France | CHU de RENNES | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the effectiveness of 3 methods of teaching oral hygiene in terms of controlling biofilm formation: MOP (Modified Orthodnotic Plaque Index) classification | The average plaque index at six months after inclusion according to the MOP (Modified Orthodnotic Plaque Index) classification. It is evaluated on macro photography in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit. | 6 months of intervention | |
Secondary | Compare the effectiveness of three teaching methods in oral hygiene for the control of gum inflammation: gingival index at six months after inclusion according to the Loë and Silness scale | The mean gingival index at six months after inclusion according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit. | 6 months after bonding the device. | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit. | J0 (during the installation of the device) | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit. | J0 (during the installation of the device) | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit. | at 1½ months after installation of the device | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit. | at 1½ months after installation of the device | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit. | at 3 months after installation of the device | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit. | at 3 months after installation of the device | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit. | at 4½ months after installation of the device | |
Secondary | Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale | The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit. | at 4½ months after installation of the device |
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