Palate, Cleft Clinical Trial
— ORTHOQOLOfficial title:
Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context
The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | February 2023 |
| Est. primary completion date | February 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Inclusion Criteria: - Man and woman ; Age: adolescents (12-17 years) and adults; Specific medical conditions: cleft lip and palate, malocclusion - Non-opposition of the patient - Patient willing to comply with all procedures of the study and its duration Exclusion Criteria - Cancellation of orthognathic surgery - Impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Roger Salengro, CHU | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively. | The OQLQ questionnaire is composed of 22 items that can be rated from 0 to 4. The score varies from 0 to 88. This questionnaire is specific to the evaluation of quality of life in relation to orthognathic surgery. | between the preoperative assessment and at 6 months postoperatively. | |
| Secondary | Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively. | The questionnaire is a non-specific questionnaire assessing quality of life in relation to general oral health. It is composed of 14 questions that can be scored from 0 to 4. The score varies from 0 to 56. | between the preoperative assessment and at 6 months postoperatively. | |
| Secondary | Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery | the type of orthognathic surgery performed = monomaxillary versus bimaxillary | at 6 months | |
| Secondary | Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery | the type of orthognathic surgery performed = monomaxillary versus bimaxillary | at 6 months |