None listed
Conditions
Brief summary
Dental caries is the most common chronic childhood disease in New Zealand. Traditional treatment involves surgical removal of the infected dental tissues and restoration using a filling material. The Hall Technique (HT) is known as a ‘no drill, no pain’ restorative procedure using metal preformed crowns (PFCs). Although effective clinically, this technique has an aesthetic limitation—the crown is silver rather than tooth-coloured. The metal PFCs also have other disadvantages: cost to healthcare providers is high and placement can be difficult. Our research team has successfully developed a novel white shell crown system for the Hall Technique, improving both aesthetics and crown placement, while reducing treatment costs. Tooth-coloured prototype crowns have been validated; however, its clinical feasibility needs to be tested.
Interventions
Developed novel white shell preformed crowns specially designed by the research team will be used.
The clinical procedure for the white shell crowns will follow the current protocol for the Hall Technique.
1) Children will be seated upright or lying down on a dental chair. O-rings will be placed in between teeth if space is inadequate; 2) Obvious food or debris will be washed from the cavity but no decay will be removed. 3) The correct size of white shell crown/metal PFC will be selected and t
Developed novel white shell preformed crowns specially designed by the research team will be used. The clinical procedure for the white shell crowns will follow the current protocol for the Hall Technique. 1) Children will be seated upright or lying down on a dental chair. O-rings will be placed in between teeth if space is inadequate; 2) Obvious food or debris will be washed from the cavity but no decay will be removed. 3) The correct size of white shell crown/metal PFC will be selected and tried on the tooth.; 4) The tooth and stainless-steel crown (SSC) will be rinsed and dried.; 5) The SSC will be filled with glass ionomer luting cement.; 6) The SSC will be placed firmly on the tooth and the child will be instructed to bite down until the crown is pushed over the tooth; 7) Extruded cement is then removed. These clinical procedures will be carried out by trained dental therapists and/or oral health therapists at dental hubs within Southern Te Whatu Ora DHB. Multiple training sessions will be given to DTs/OHTs and the research team to ensure data accuracy and protocol compliance. The anticipated duration of the clinical procedures is 15 minutes per participant. The feasibility clinical trial will end as soon as the target number of participants is reached. Then the follow-up will take in place. In addition to 3-,6-, and 12-monthly phone calls, parents of participants will be encouraged to contact the research team or DT/OHT at any time for any concerns about the adverse effects of the treatment.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
- all ethnicities, ages between 5-7 years - willing to be examined by an oral health clinician - any primary teeth requiring conventional Hall crowns (i.e. stainless-steel crowns) as a conservative treatment for dental caries
Exclusion criteria
Multiple metal PFCs already placed - have teeth-grinding habits or bruxism. - medically-compromised - unable to complete questionnaire
Outcome results
None listed