Paediatric Dentistry Clinical Trial
Official title:
SIXES: Should I eXtract Every Six? A Randomized Clinical Trial of the Extraction of First Permanent Molar Teeth in Children
This clinical trial investigates relative benefits (clinical effectiveness and quality of life) of two extraction patterns when lower first permanent molars (FPM) are extracted in children The study objectives are to determine whether compensating extraction of upper FPMs following loss of lower FPMs in children is of benefit. The particular benefits being investigated are related to the resulting occlusion, patient experience and oral health related quality of life. The follow up will extend over a period of 5 years or until the patient is 14 years of age - whichever is earlier.
The study has been designed as a randomised controlled clinical trial. The control group will
have the normal standard intervention receiving routine patient care with the normal practice
of upper and lower extractions, whilst the intervention group will have removal of the lower
tooth but no upper extraction. Study recruitment will take place over an 18 month period and
will be based in the Dundee Dental Hospital Orthodontic and Paediatric Dentistry Departments.
Patients are referred to this department from their General Dental Practitioner.
Consent of the patients will be carried out by the attending dentists who will have received
training on the study design and protocol, including RGF and consenting patients for clinical
trials.
Data will be collected contemporaneously using the Case Report Forms. Additional data which
will be collected for the purposes of the study will include COHQoL questionnaires and
measurements from 3D images of models of the teeth.
At subsequent 1 year and five year review visits dental study 3D models will be repeated, and
the CRF completed together with the COHQoL questionnaire for that visit.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05848388 -
Molar Incisor Malformation in Egypt
|