Effect of Alveolar Bone Grafting

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03549039

Enrollment

Registered

2018-06-07

Start date

2018-06-30

Completion date

2018-07-15

Last updated

2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Grafting, Quality of Life

Keywords

quality of life, cleft lip, cleft palate

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.

Countries

Turkey (Türkiye)

Outcome results