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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2023

Clinical Trial Outcome Measures

Primary Measures

  • Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively.
    • Time Frame: 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 Measures

  • Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively.
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: at 6 months
    • the type of orthognathic surgery performed = monomaxillary versus bimaxillary

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Romain Nicot, MD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Romain Nicot, MD, 0320446360, romain.nicot@chru-lille.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.