Effect of Alveolar Bone Grafting

NCT03549039 | Completed

• 1 other identifier: 36290600/22
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Grafting; Quality of Life

Keywords

quality of life; cleft lip; cleft palate

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent surgery due to alveolar cleft

You may qualify if:

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

You may not qualify if:

• patients who don't accept to join questionnaire

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University dentisry of faculty

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 21865051 BACKGROUND

• 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.

  PMID: 11519772 BACKGROUND

• 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.

  PMID: 12923507 BACKGROUND

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Officials

• Kevser Sancak

  Ankara University Faculty of Dentısry

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: June 7, 2018
• Study Start: June 30, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 15, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

TU (1)