Effect of Alveolar Bone Grafting

Quality of Life Clinical Trial

Official title:

Effect of Alveolar Bone Grafting on Health Quality in Patients With Cleft Lip and Palate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549039
• Other study ID #: 36290600/22
• Status: Completed
• Start date: June 30, 2018
• Est. completion date: July 15, 2018

Study information

• Verified date: February 2019
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 15, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Grafting
• Quality of Life

Locations

Country	Name	City	State
Turkey	Ankara University dentisry of faculty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Form Health Survey (SF-12) Physical Component Summary	all participants will be called to faculty. SF-12 will be done. SF-12 is calculated using the scoring table. Health-related quality of life, which was measured using the Physical Component Summary (PCS) scores of SF-12 was assessed. Physical component is scored from 0 to 100 with 0 representing the worst and 100 representing the best health status.	20 minutes
Primary	Short-Form Health Survey (SF-12) Mental Component Summary	all participants will be called to faculty. SF-12 will be done. SF-12 is calculated using the scoring table. Health-related quality of life, which was measured using the Mental Component Summary (MCS)scores of SF-12 was assessed. Mental component is scored from 0 to 100 with 0 representing the worst and 100 representing the best health status.	20 minutes
Primary	Postsurgical Patient Satisfaction Questionnaire (PSPSQ)	all participants will be called to faculty. PSPSQ will be done. Patient satisfaction will be assessed by analyzing data gathered from PSPSQ. PSPSQ included seven questions. It is designed to assess each patient's overall satisfaction with the procedure(s), functional improvements, and recognized or perceived negative effects of the procedures. The 7-point Likert (poor to excellent), scale is used so that the person who answers the questions can rate the level of related satisfaction with each question. The final outcome is between 7 and 49. Higher scores are associated with satisfaction.	20 minutes