Recruiting

Orthodontic Bands & Glass Ionomer Cement

Sponsor:

Medical College of Wisconsin

Code:

NCT04538963

Conditions

Dental Caries Class II

Dental Caries in Children

Dental Caries on Smooth Surface Limited to Enamel

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Accepted

Interventions

Orthodontic Band affixed with Glass Ionomer Cement

Study Details

Brief 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.

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.

Conditions

Dental Caries Class II

Dental Caries in Children

Dental Caries on Smooth Surface Limited to Enamel

Study ID

NCT04538963

Start date

Sep 3, 2020

Status verified date

Sep, 2021

Completion date

Jun, 2023

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion criteria

  • 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

Study Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Banded Tooth

This tooth will have an orthodontic band and glass ionomer cement placed as an intervention for interproximal incipient caries.

no intervention: Non-banded Tooth

This tooth will be monitored per standard of care; encourage good dental hygiene at home.

Interventions

Orthodontic Band affixed with Glass Ionomer Cement

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.

Primary outcome measure

  • Radiographic Assessment of Interproximal Carious lesions [ Time Frame: 6 months from previous recall visit ]

Central Contacts and Locations

Central contacts

Macaire C Thiel, DDS MS

9202842414MThiel@chw.org

Christopher Niu, DDS

4142662040CNiu@chw.org

Locations

Children's Dental Center- Downtown

Recruiting

Milwaukee, Wisconsin, United States, 53201

Contacts

Macaire Thiel, DDS, MS

414-277-8960MThiel@chw.org

Children's Dental Center

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Macaire Thiel, DDS, MS

414-266-2040Mthiel@chw.org

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 5, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2021-09-05.