- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03549039
Effect of Alveolar Bone Grafting
February 4, 2019 updated by: Kevser Sancak, Ankara University
Effect of Alveolar Bone Grafting on Health Quality in Patients With Cleft Lip and Palate
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06500
- Ankara University dentisry of faculty
-
-
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
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients who underwent surgery due to alveolar cleft
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-Form Health Survey (SF-12) Physical Component Summary
Time Frame: 20 minutes
|
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
Time Frame: 20 minutes
|
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)
Time Frame: 20 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kevser Sancak, Ankara University Faculty of Dentısry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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, 2018
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 15, 2018
Study Registration Dates
First Submitted
April 8, 2018
First Submitted That Met QC Criteria
June 6, 2018
First Posted (Actual)
June 7, 2018
Study Record Updates
Last Update Posted (Actual)
February 5, 2019
Last Update Submitted That Met QC Criteria
February 4, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 36290600/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
de-identified individual participant data for all primary and secondary outcome measures will be made available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia