Effect of Alveolar Bone Grafting

Sponsor
Ankara University (Other)
Overall Status
Completed
CT.gov ID
NCT03549039
Collaborator
(none)
28
1
15
56.8

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jun 30, 2018
    Actual Primary Completion Date :
    Jul 1, 2018
    Actual Study Completion Date :
    Jul 15, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Short-Form Health Survey (SF-12) Physical Component Summary [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 [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara University dentisry of faculty Ankara Turkey 06500

    Sponsors and Collaborators

    • Ankara University

    Investigators

    • Study Chair: Kevser Sancak, Ankara University Faculty of Dentısry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kevser Sancak, research assistant, Ankara University
    ClinicalTrials.gov Identifier:
    NCT03549039
    Other Study ID Numbers:
    • 36290600/22
    First Posted:
    Jun 7, 2018
    Last Update Posted:
    Feb 5, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kevser Sancak, research assistant, Ankara University

    Study Results

    No Results Posted as of Feb 5, 2019