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

NCT ID: NCT04049058

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-30

Study Completion Date

2023-02-28

Brief Summary

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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

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Conditions

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Palate, Cleft

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Romain Nicot, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHU

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Romain Nicot, MD

Role: CONTACT

Phone: 0320446360

Email: [email protected]

Other Identifiers

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2018-A03376-49

Identifier Type: OTHER

Identifier Source: secondary_id

2018_55

Identifier Type: -

Identifier Source: org_study_id