Dental Caries Class IINCT04538963
Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement
A study testing Orthodontic Band affixed with Glass Ionomer Cement in people with Dental Caries Class II and Dental Caries in Children, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of using orthodontic bands with glass ionomer cement to arrest or reverse interproximal lesions as a preventive treatment compared to monitoring and oral hygiene. Read more about this study
- Who is it for?
- Ages 5 years to 209 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class II, Dental Caries in Children, Dental Caries on Smooth Surface Limited to Enamel
- What is being tested?
- Orthodontic Band affixed with Glass Ionomer Cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2020to Jun 2023
- Phase
- Interventional
- 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 years to 209 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children
- Children or adolescents (Age 5<17.5yrs) who have erupted permanent teeth that make interproximal contact with other teeth, either primary or permanent teeth.
- Presence of at least one pair of interproximal carious lesions (E1, E2, early D1 according to the ADA CCS), evaluated by radiographic analysis, on permanent premolars or molars that do not require surgical intervention. If multiple pairs of lesions are present, they may be included in the study as well.
Who cannot join
- Patients who will be undergoing orthodontic treatment in the following 12 months.
- Patients with a poor behavior rating at their dental visit, defined with a (--) designation in behavior note
- Patients noted to have severe plaque levels and generalized severe gingivitis.
- Teeth with advanced caries into dentin that require surgical intervention restoration (Mid D1-D3). Dental needs that are required will be completed by the primary dental provider in the Dental Clinic
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Children's Dental Center- Downtown
Milwaukee, Wisconsin, 53201
Macaire Thiel, DDS, MS, 414-277-8960, MThiel@chw.org
Christopher Niu, DDS
- Recruiting
Children's Dental Center
Milwaukee, Wisconsin, 53226
Macaire Thiel, DDS, MS, 414-266-2040, Mthiel@chw.org
Christopher Niu, DDS
About this study
Official title: Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement as a Preventative Intervention: A Split Mouth Study
The purpose of this study is to evaluate the efficacy of using orthodontic bands with glass ionomer cement to arrest or reverse interproximal lesions as a preventive treatment compared to monitoring and oral hygiene.
The investigators hypothesize that placing orthodontic bands with glass ionomer cement will arrest and possibly remineralize incipient carious lesions compared to teeth that are being monitored without intervention.
Read the detailed description
This study is designed to determine the efficacy of orthodontic bands and glass ionomer cement in arresting and remineralizing incipient carious lesions as compared to monitoring for changes.
This is a single blinded, split mouth randomized control trial, with the patient being their own control. A split mouth study is considered the gold standard because both experimental and control groups are exposed to the same environmet and conditions within the mouth. This study design eliminates confounding variables that may occur that could significantly alter the interpretation of end results (e.g. oral hygiene effectiveness between two patients).
Participants will be screened at their routine periodic dental examination, where they will receive a dental exam, prophylaxis (cleaning), radiographs and fluoride varnish application in accordance with the guidelines from the American Academy of Pediatric Dentistry. Radiographs will be examined by an evaluator to determine if participants meet the inclusion criteria. Each participant requires at least one pair of permanent posterior teeth with interproximal caries lesions in enamel or in proximity of the dentinal enamel junction (E1, E2, early D1). An ideal pair consists of the same tooth type on the left and right side of the mouth (i.e. tooth #5 and #12, maxillary right permanent first premolar and maxillary left permanent first premolar). Another acceptable type of pair is same tooth type (i.e. tooth #5 and #21, maxillary right permanent first premolar and mandibular left permanent first premolar) or two adjacent teeth (i.e tooth #19 and 18 mandibular left first and second molar). Additionally, patients may also be screened when coming in for other dental treatment as well.
Each participant will have his or her qualifying lesions randomized equally into two groups, one that will receive the band, and one that will not. Envelopes will contain the treatment conditions: Left/Upper/Distal or Right/Lower/Mesial, to indicate that the lesion on either the left/upper/distal or right/lower/mesial side of the mouth will get banded. They will be randomly organized and then ordered in the box.
After randomization has occurred, each participant will have a blank orthodontic band (Denovo) fitted on the treatment lesion and cemented with glass ionomer cement (Fuji). Additionally, oral hygiene instructions will be reinforced. Participants will be instructed to return for their routine periodic dental exam in 6 months. Because the intervention is obvious, blinding the patient or the operator is not possible. At the 6 month visit, the band will be removed with a band remover prior to their dental exam and cleaning. Routine radiographs (according to the AAPD's radiographic guidelines) will be taken after the band has been removed. 20,21,22
A blinded second investigator will examine the pre and post treatment radiographs. Lesions will be classified initially by ADA CCS, and change will be noted as: progression, arrest, or regression. A de-identified data sheet containing the data will be sent to a statistician and a McNemar's Chi-square test will be used to test the differences in the lesion status of both groups
- Conditions
- Dental Caries Class II, Dental Caries in Children, Dental Caries on Smooth Surface Limited to Enamel
- Being tested
- Orthodontic Band affixed with Glass Ionomer Cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic Band affixed with Glass Ionomer CementDevice
Glass ionomer cement utilized to affix a blank orthodontic band to the tooth; the mechanical retention of the band will also help retain cement in contact with the tooth- the hypothesis is that the fluoride release from the cement will aid in remineralization of tooth structure.
| Study group | Role | What they receive |
|---|---|---|
| Banded Tooth | Experimental | This tooth will have an orthodontic band and glass ionomer cement placed as an intervention for interproximal incipient caries. Receives: Device: Orthodontic Band affixed with Glass Ionomer Cement |
| Non-banded Tooth | No intervention | This tooth will be monitored per standard of care; encourage good dental hygiene at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Assessment of Interproximal Carious lesions
Review of radiographs to assess if carious lesions have progressed or stabilized over time
Measured: 6 months from previous recall visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start3 Sep 2020
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Class IIStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split-mouth design- individual patient has a pair of carious lesions; one will receive the intervention, the other will be monitored per standard of care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Macaire Thiel, Medical College of Wisconsin
- Investigators
- Macaire C Thiel, DDS MS, Principal investigator, Children's Hospital of Wisconsin, Pediatric Dental Residency Program Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538963
- Sponsor's protocol ID
- 1554245
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement as a Preventative Intervention: A Split Mouth Study
- ClinicalTrials.gov ID
- NCT04538963
- Acronym / sponsor ID
- 1554245
- Conditions
- Dental Caries Class II, Dental Caries in Children, Dental Caries on Smooth Surface Limited to Enamel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Sep 2020 (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 purpose of this study is to evaluate the efficacy of using orthodontic bands with glass ionomer cement to arrest or reverse interproximal lesions as a preventive treatment compared to monitoring and oral hygiene.
The investigators hypothesize that placing orthodontic bands with glass ionomer cement will arrest and possibly remineralize incipient carious lesions compared to teeth that are being monitored without intervention.
Detailed description
This study is designed to determine the efficacy of orthodontic bands and glass ionomer cement in arresting and remineralizing incipient carious lesions as compared to monitoring for changes.
This is a single blinded, split mouth randomized control trial, with the patient being their own control. A split mouth study is considered the gold standard because both experimental and control groups are exposed to the same environmet and conditions within the mouth. This study design eliminates confounding variables that may occur that could significantly alter the interpretation of end results (e.g. oral hygiene effectiveness between two patients).
Participants will be screened at their routine periodic dental examination, where they will receive a dental exam, prophylaxis (cleaning), radiographs and fluoride varnish application in accordance with the guidelines from the American Academy of Pediatric Dentistry. Radiographs will be examined by an evaluator to determine if participants meet the inclusion criteria. Each participant requires at least one pair of permanent posterior teeth with interproximal caries lesions in enamel or in proximity of the dentinal enamel junction (E1, E2, early D1). An ideal pair consists of the same tooth type on the left and right side of the mouth (i.e. tooth #5 and #12, maxillary right permanent first premolar and maxillary left permanent first premolar). Another acceptable type of pair is same tooth type (i.e. tooth #5 and #21, maxillary right permanent first premolar and mandibular left permanent first premolar) or two adjacent teeth (i.e tooth #19 and 18 mandibular left first and second molar). Additionally, patients may also be screened when coming in for other dental treatment as well.
Each participant will have his or her qualifying lesions randomized equally into two groups, one that will receive the band, and one that will not. Envelopes will contain the treatment conditions: Left/Upper/Distal or Right/Lower/Mesial, to indicate that the lesion on either the left/upper/distal or right/lower/mesial side of the mouth will get banded. They will be randomly organized and then ordered in the box.
After randomization has occurred, each participant will have a blank orthodontic band (Denovo) fitted on the treatment lesion and cemented with glass ionomer cement (Fuji). Additionally, oral hygiene instructions will be reinforced. Participants will be instructed to return for their routine periodic dental exam in 6 months. Because the intervention is obvious, blinding the patient or the operator is not possible. At the 6 month visit, the band will be removed with a band remover prior to their dental exam and cleaning. Routine radiographs (according to the AAPD's radiographic guidelines) will be taken after the band has been removed. 20,21,22
A blinded second investigator will examine the pre and post treatment radiographs. Lesions will be classified initially by ADA CCS, and change will be noted as: progression, arrest, or regression. A de-identified data sheet containing the data will be sent to a statistician and a McNemar's Chi-square test will be used to test the differences in the lesion status of both groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design- individual patient has a pair of carious lesions; one will receive the intervention, the other will be monitored per standard of care.
| Arm | Type | Receives |
|---|---|---|
| Banded Tooth | Experimental | Device: Orthodontic Band affixed with Glass Ionomer CementThis tooth will have an orthodontic band and glass ionomer cement placed as an intervention for interproximal incipient caries. |
| Non-banded Tooth | No intervention | –This tooth will be monitored per standard of care; encourage good dental hygiene at home. |
Who may qualify
- Ages
- 5 years to 209 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children
- Children or adolescents (Age 5<17.5yrs) who have erupted permanent teeth that make interproximal contact with other teeth, either primary or permanent teeth.
- Presence of at least one pair of interproximal carious lesions (E1, E2, early D1 according to the ADA CCS), evaluated by radiographic analysis, on permanent premolars or molars that do not require surgical intervention. If multiple pairs of lesions are present, they may be included in the study as well.
Key exclusion criteria (4 listed)
- Patients who will be undergoing orthodontic treatment in the following 12 months.
- Patients with a poor behavior rating at their dental visit, defined with a (--) designation in behavior note
- Patients noted to have severe plaque levels and generalized severe gingivitis.
- Teeth with advanced caries into dentin that require surgical intervention restoration (Mid D1-D3). Dental needs that are required will be completed by the primary dental provider in the Dental Clinic
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 |
|---|---|---|
| Orthodontic Band affixed with Glass Ionomer CementGlass ionomer cement utilized to affix a blank orthodontic band to the tooth; the mechanical retention of the band will also help retain cement in contact with the tooth- the hypothesis is that the fluoride release from the cement will aid in remineralization of tooth structure. | Device | Banded Tooth |
Primary outcome
Radiographic Assessment of Interproximal Carious lesions
Time frame: 6 months from previous recall visit
Review of radiographs to assess if carious lesions have progressed or stabilized over time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- 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.
Macaire C Thiel, DDS MS principal investigator
Children's Hospital of Wisconsin, Pediatric Dental Residency Program Faculty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic Band affixed with Glass Ionomer Cement in people with Dental Caries Class II and Dental Caries in Children, run by Medical College of Wisconsin at 2 sites in United States.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Macaire C Thiel, DDS MS (9202842414, MThiel@chw.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Assessment of Interproximal Carious lesions (time frame: 6 months from previous recall visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2021.