Clinical trial NCT03549039: Effect of Alveolar Bone Grafting
Official title: Effect of Alveolar Bone Grafting on Health Quality in Patients With Cleft Lip and Palate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Bone Grafting
Quality of Life
Keywords: quality of life
cleft lip
cleft palate
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent surgery due to alveolar cleft

Brief summary: This study included patients who underwent secondary alveolar bone grafting by harvesting graft from the anterior iliac crest, in Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University, Turkey, during the period from January 2012 to March 2016. All patients were operated using the same technique and by the same surgical team. Patients will be interviewed to fill Short-Form Health Survey (SF-12) and Postsurgical Patient Satisfaction Questionnaire (PSPSQ) 6 months postoperatively. The questionnaires will be used to assess the relationship between health quality and patient satisfaction. Also, grafted sites will be evaluated with respect to fistula, the presence of cleft palate, and infection.The descriptive statistics and Pearson correlation analyses will be made using PSPSQ scores and SF-12 PCS and MCS scores.

Detailed description: The postsurgical patient satisfaction questionnaire (PSPSQ) was designed to assess each patient's overall satisfaction with the procedure(s), functional improvements, and recognized or perceived negative effects of the procedures. One of the most commonly used measures of HRQoL is SF-36, which has been reduced to 12 items with the minimal loss of information to form SF-12 . HRQoL was assessed using SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.

Eligibility criteria: Inclusion Criteria:

patients who were undergone alveolar cleft surgery before at our hospital at least 6 months after surgery

Exclusion Criteria:

patients who don't accept to join questionnaire

Primary outcomes:
measure: Short-Form Health Survey (SF-12) Physical Component Summary
timeFrame: 20 minutes
measure: Short-Form Health Survey (SF-12) Mental Component Summary
timeFrame: 20 minutes
measure: Postsurgical Patient Satisfaction Questionnaire (PSPSQ)
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University dentisry of faculty
Study officials:
affiliation: Ankara University Faculty of Dentısry
name: Kevser Sancak
role: STUDY_CHAIR
References:
citation: Rustemeyer J, Gregersen J. Quality of Life in orthognathic surgery patients: post-surgical improvements in aesthetics and self-confidence. J Craniomaxillofac Surg. 2012 Jul;40(5):400-4. doi: 10.1016/j.jcms.2011.07.009. Epub 2011 Aug 23.
citation: Gandhi SK, Salmon JW, Zhao SZ, Lambert BL, Gore PR, Conrad K. Psychometric evaluation of the 12-item short-form health survey (SF-12) in osteoarthritis and rheumatoid arthritis clinical trials. Clin Ther. 2001 Jul;23(7):1080-98. doi: 10.1016/s0149-2918(01)80093-x.
citation: Motegi E, Hatch JP, Rugh JD, Yamaguchi H. Health-related quality of life and psychosocial function 5 years after orthognathic surgery. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):138-43. doi: 10.1016/s0889-5406(03)00391-3.