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Occlusal Compensation After the Hall Technique

NCT04001153 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-11-02

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

OTHER

Dental impressions

Children will be included in this study if they already are treatment planned to receive a Hall Technique preformed metal crown (HTPMC) to manage carious lesions in primary molars. They will have a dental impression taken before and after the HTPMC placement to find out what happens with their bite after the treatment. The dental impressions will be cast up into stone study models so that we can track the changes that happens in children's bites after placing the HTPMC (as it increases the height of children's bite when placed) and let them know what to expect after this procedure and as part of this study, additional follow-ups will be required 2, 4, 6 and 8 weeks after the HTPMC placement to allow us to track the changes in the bite at regular intervals to see when the child's bite returns to its pre-treatment state.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • University of Dundee

    lead OTHER

Principal Investigators

  • Mariana Araujo · University of Dundee/University of São Paulo

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-10
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • United Kingdom

Study Locations

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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 NCT04001153 on ClinicalTrials.gov