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Clinical Trial Summary

The Hall Technique preformed metal crown (HTPMC) is used to treat decayed primary molars. The correct size is chosen and pushed over the tooth with no tissue removal. A side-effect of the HTPMC is the increasing of tooth's height changing the child's bite vertically, resulting in a premature contact on the crowned tooth. Clinical trials have looked at it and measured the initial and final vertical change (after the HTPMC placement) and have found that vertical dimension (VD) is re-established within a few weeks. They suggest that there might be a compensatory mechanism related to the crowned tooth/its opposing tooth. None of these trials measured how long it took the occlusion to return to its pre-crown state, merely observing at convenient follow-up times that it happens. Neither has there been any investigation into the mechanisms by which the compensation occurs. A pilot trial was conducted at Dundee Dental School (DDS) in 2013 to find the best and most reproducible method to measure the change in VD after HTPMC placement. It compared 4 different approaches: direct clinical measurement; clinical photographs; direct measurement of stone study models and digital subtraction of 3D models, showing that the most reliable method to measure the differences in VD was the digital subtraction of 3D models. This method could detect whether the occlusion returned to its pre-crown state regarding the overbite and also gave an indication of appropriate follow-up timeframe to evaluate this resolution. These are preliminary results and the pilot study was designed to guide future research. There were no previous reliable data regarding the evaluation of VD and its effects when this pilot study was conducted. A random sample size was selected to give insight to build a future power calculation for future studies. The investigators would like to continue this pilot work and carry out a full study recruiting children that are assigned to receive a HTPMC during routine appointments in the DDS. By understanding where occlusal compensation occurs in the mouth following placement of a HTPMC, and how long this takes to occur, more accurate information can be given to parents on what to expect following treatment, supporting joint treatment planning and decision making regarding the dental care of the child. In addition, where more than one crown is required, treatment planning can be timed more precisely to ensure future treatment is carried out at the optimal time.


Clinical Trial Description

This is a prospective observational cohort study involving children undergoing treatment at Dundee Dental Hospital & School. The study involves taking additional measurements of children who have already had treatment planned that includes a HTPMC (having a crown placed over a decayed tooth). There will be no interventions or invasive procedures as part of this study. As an additional procedure, specific to this study (not included in the standard care), participants will have dental impressions taken to compare pre and post HTPMC placement (right after the treatment and at 2, 4, 6, and 8 weeks follow-up) state of their mouths. Dental impressions are a routine procedure that children regularly undergo for orthodontic treatment or to make mouth guards for sports. Children having a HTPMC fitted would not have a dental impression taken before and after the HTPMC placement or at subsequent appointments as part of standard care. Since the aim is to track the changes that happen in children's mouth, the investigators are going to use these extra procedures of taking dental impressions to analyse digitally (by making a 3D scan of the stone study models). This will allow us to see how long it takes for the children's vertical dimension to come back to its pre-treatment state and what the changes are that happen in their mouth after the placement of a HTPMC. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04001153
Study type Observational
Source University of Dundee
Contact
Status Withdrawn
Phase
Start date July 10, 2019
Completion date July 31, 2020

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