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Occlusal Compensation After the Hall Technique (CHAT)

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ClinicalTrials.gov Identifier: NCT04001153
Recruitment Status : Withdrawn (There will be no opportunity to recruit patients during the pandemic of COVID-19 and possibly even post-pandemic)
First Posted : June 27, 2019
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Nicola Innes, University of Dundee

Brief 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.


Condition or disease Intervention/treatment
Dental Caries Other: Dental impressions

Detailed 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Occlusal Compensation After the Placement of Preformed Metal Crowns Using the Hall Technique for Carious Primary Molars; Where it Occurs and Clinical Implications
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Group/Cohort Intervention/treatment
Upper primary first molar
Children already treatment planned to have a Hall Technique crown placed to manage primary molars carious lesions will have dental impressions taken before the crown placement, immediately after and at 2, 4, 6 and 8 weeks follow-up.
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.


Lower primary first molar
Children already treatment planned to have a Hall Technique crown placed to manage primary molars carious lesions will have dental impressions taken before the crown placement, immediately after and at 2, 4, 6 and 8 weeks follow-up.
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.


Upper primary second molar
Children already treatment planned to have a Hall Technique crown placed to manage primary molars carious lesions will have dental impressions taken before the crown placement, immediately after and at 2, 4, 6 and 8 weeks follow-up.
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.


Lower primary second molar
Children already treatment planned to have a Hall Technique crown placed to manage primary molars carious lesions will have dental impressions taken before the crown placement, immediately after and at 2, 4, 6 and 8 weeks follow-up.
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.





Primary Outcome Measures :
  1. The height of the crowned tooth and its opposing tooth. [ Time Frame: Immediately after, at 2, 4, 6 and 8 weeks following placement of the Hall Technique Preformed Metal Crown. ]
    Changes in teeth height will be measured in millimetres using a digital software.


Secondary Outcome Measures :
  1. Height difference in the crowned tooth and the vertical dimension. [ Time Frame: Immediately after, at 2, 4, 6 and 8 weeks following placement of the Hall Technique Preformed Metal Crown. ]
    Measured by the increase in the height of canines on stone study models in millimetres using a digital software.

  2. The difference in height of the crowned tooth, the opposing and adjacent teeth. [ Time Frame: Immediately after, at 2, 4, 6 and 8 weeks following placement of the Hall Technique Preformed Metal Crown. ]
    Teeth height will be measured in millimetres using a digital software.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children from 5 to 9 years old undergoing dental treatments at Children's Clinic in Dundee Dental Hospital & School, University of Dundee
Criteria

Inclusion Criteria:

  • children aged from 5 to 9 years old
  • children who are eligible to receive a HTPMC to manage primary molars carious lesions;
  • children who have not had a HTPMC fitted within the last 6 weeks;
  • children who understand what is involved in the study and have signed and given assent to participate;
  • children that can cooperate with dental care including having a dental impression taken; and
  • children whose parents are willing and able to attend the follow-up appointments 2, 4, 6 and 8 weeks after the treatment.

Exclusion Criteria:

  • children who do not have parental agreement to participate; or
  • children who have self-reported occlusal parafunctional habits (e.g. bruxism, constantly open mouths).

Individuals will not be enrolled to the study if they are participating in the clinical phase of another interventional trial/study or have done so within the last 30 days. Individuals who are participating in the follow-up phase of another interventional trial/study, or who are enrolled in an observational study, will be co-enrolled where the Chief Investigators of each study agree that it is appropriate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001153


Locations
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United Kingdom
University of Dundee
Dundee, Scotland, United Kingdom, DD1 4HR
Sponsors and Collaborators
University of Dundee
University of Sao Paulo
Investigators
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Principal Investigator: Mariana Araujo University of Dundee/University of São Paulo
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Nicola Innes, Professor of Paediatric Dentistry & Associate Dean for Teaching and Learning, University of Dundee
ClinicalTrials.gov Identifier: NCT04001153    
Other Study ID Numbers: 1-006-19
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicola Innes, University of Dundee:
Hall Technique
Primary Molar
Vertical Dimension
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases