Dental CariesCHATNCT04001153
Occlusal Compensation After the Hall Technique
An observational study of Dental Caries, run by University of Dundee at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Dental impressions
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from 5 to 9 years old undergoing dental treatments at Children's Clinic in Dundee Dental Hospital \& School, University of Dundee
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Dental impressions
- Keywords
- Hall Technique, Primary Molar, Vertical Dimension
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental impressionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dental impressions | |
| 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. Receives: Other: Dental impressions | |
| 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. Receives: Other: Dental impressions | |
| 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. Receives: Other: Dental impressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The height of the crowned tooth and its opposing tooth.
Changes in teeth height will be measured in millimetres using a digital software.
Measured: Immediately after, at 2, 4, 6 and 8 weeks following placement of the Hall Technique Preformed Metal Crown.
Secondary outcomes (2)
Height difference in the crowned tooth and the vertical dimension.
Measured by the increase in the height of canines on stone study models in millimetres using a digital software.
Measured: Immediately after, at 2, 4, 6 and 8 weeks following placement of the Hall Technique Preformed Metal Crown.
The difference in height of the crowned tooth, the opposing and adjacent teeth.
Teeth height will be measured in millimetres using a digital software.
Measured: Immediately after, at 2, 4, 6 and 8 weeks following placement of the Hall Technique Preformed Metal Crown.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start10 Jul 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: There will be no opportunity to recruit patients during the pandemic of COVID-19 and possibly even post-pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Nicola Innes, University of Dundee
- Investigators
- Mariana Araujo, Principal investigator, University of Dundee/University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001153
- Sponsor's protocol ID
- 1-006-19
- Acronym
- CHAT
- Status last verified
- Oct 2020
- First submitted
- 24 Jun 2019
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ludwig KH, Fontana M, Vinson LA, Platt JA, Dean JA. The success of stainless steel crowns placed with the Hall technique: a retrospective study. J Am Dent Assoc. 2014 Dec;145(12):1248-53. doi: 10.14219/jada.2014.89.
PubMed 25429038Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.
PubMed 18096042So D, Evans DJ, Borrie F, Roughley M, Lamont T, Keightley A, Innes NPT: Measurement of occlusal equilibration following Hall crown placement - a pilot study (abstract). J Dent Res 2015;94(spec. issue A):0080.
van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
PubMed 20932395
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04001153
- Acronym / sponsor ID
- CHAT / 1-006-19
- Conditions
- Dental Caries
- Keywords
- Hall Technique, Primary Molar, Vertical Dimension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: There will be no opportunity to recruit patients during the pandemic of COVID-19 and possibly even post-pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Upper primary first molar | – | Other: Dental impressionsChildren 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. |
| Lower primary first molar | – | Other: Dental impressionsChildren 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. |
| Upper primary second molar | – | Other: Dental impressionsChildren 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. |
| Lower primary second molar | – | Other: Dental impressionsChildren 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. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from 5 to 9 years old undergoing dental treatments at Children's Clinic in Dundee Dental Hospital \& School, University of Dundee
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental impressionsChildren 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. | Other | Lower primary first molar, Lower primary second molar, Upper primary first molar, Upper primary second molar |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 25429038Ludwig KH, Fontana M, Vinson LA, Platt JA, Dean JA. The success of stainless steel crowns placed with the Hall technique: a retrospective study. J Am Dent Assoc. 2014 Dec;145(12):1248-53. doi: 10.14219/jada.2014.89.
- Background: PubMed 18096042Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.
- BackgroundSo D, Evans DJ, Borrie F, Roughley M, Lamont T, Keightley A, Innes NPT: Measurement of occlusal equilibration following Hall crown placement - a pilot study (abstract). J Dent Res 2015;94(spec. issue A):0080.
- Results publication: PubMed 20932395van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Araujo principal investigator
University of Dundee/University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001153, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.