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

November 19, 2020 updated by: University Hospital, Lille
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Roger Salengro, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cleft lip and palate with malocclusion and indication of orthognathic surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between the preoperative assessment and at 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between the preoperative assessment and at 6 months postoperatively.
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
at 6 months
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
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Romain Nicot, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2019

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_55
  • 2018-A03376-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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