Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context

• Conditions: Palate, Cleft

• Registration Number: NCT04049058
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-30
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively.	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.

Secondary Outcome Measures

Name	Time	Method
Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively.	between the preoperative assessment 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.
Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery	at 6 months	the type of orthognathic surgery performed = monomaxillary versus bimaxillary
Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery	at 6 months	the type of orthognathic surgery performed = monomaxillary versus bimaxillary

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France