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Effect of Alveolar Bone Grafting

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ClinicalTrials.gov Identifier: NCT03549039
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kevser Sancak, Ankara University

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.

Condition or disease
Alveolar Bone Grafting Quality of Life

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
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Alveolar Bone Grafting on Health Quality in Patients With Cleft Lip and Palate
Actual Study Start Date : June 30, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients who underwent surgery due to alveolar cleft
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549039


Locations
Turkey
Ankara University dentisry of faculty
Ankara, Turkey, 06500
Sponsors and Collaborators
Ankara University
Investigators
Study Chair: Kevser Sancak Ankara University Faculty of Dentısry

Publications:
Responsible Party: Kevser Sancak, research assistant, Ankara University
ClinicalTrials.gov Identifier: NCT03549039     History of Changes
Other Study ID Numbers: 36290600/22
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: de-identified individual participant data for all primary and secondary outcome measures will be made available

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kevser Sancak, Ankara University:
quality of life
cleft lip
cleft palate