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Methods of Providing Information Prior to an Alveolar Bone Graft

NCT04381078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-08-22

No results posted yet for this study

Summary

Patients born with a cleft of the lip and/or palate may have a gap in the bone in the roof of their mouth and in the area of bone where the teeth develop. These patients require an alveolar bone graft (ABG) to allow the eruption of the maxillary canine teeth amongst other reasons. The optimal time to carry this out is between the ages of nine and eleven.

Whilst the patients will have had interventions as infants, this is often the first procedure a child born with a cleft lip and/or palate is likely to comprehend.

An audio-visual guide has been developed by the Great Ormond Street Hospital Dental Department for children undergoing an ABG. It explains the reason for the procedure, what the process will involve and advice regarding postoperative care.

This study will try ascertain whether providing information to patients and parents in this manner reduces anxiety, improves understanding of why the procedure was undertaken and post-operative care.

Children between the ages of eight and twelve ready for this procedure at Great Ormond Street Hospital will be enrolled. They will be allocated into two groups during their assessment appointment. The control will be given standardised verbal and written information, whilst the experimental group will also be given the animation. The level of anxiety and understanding of the procedure will be measured after the intervention/control information and once again when the patient attends for their pre-surgical assessment two to three months later.

This study aims to see whether the patient and parent anxiety is reduced and knowledge regarding the procedure is improved when utilising this of kind audio-visual guide for children. This will indicate whether it is worthwhile committing resources to the development of similar animations for other procedures.

Conditions

  • Cleft Lip and Palate

Interventions

OTHER

ACE - AudioVisual Guide

Audiovisual guide to Alveolar Bone Graft Procedure, Pre-surgical orthodontics and post-operative care

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04381078 on ClinicalTrials.gov