Effect of Alveolar Bone Grafting

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.

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Key information

Conditions

Alveolar Bone Grafting Cleft Lip Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Quality of Life Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University dentisry of faculty

Ankara, 06500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jun 7, 2018
Registry last updated: Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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