Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement

NCT04538963 | Unknown FDA Device

• 1 other identifier: 1554245
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Radiographic Assessment of Interproximal Carious lesions

  Review of radiographs to assess if carious lesions have progressed or stabilized over time

  6 months from previous recall visit

Study Arms (2)

Banded Tooth

EXPERIMENTAL

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

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.

Interventions

Orthodontic Band affixed with Glass Ionomer Cement DEVICE

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.

Banded Tooth

Eligibility Criteria

• Age: 5 Years - 209 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (2)

Children's Dental Center- Downtown

Milwaukee, Wisconsin, 53201, United States

RECRUITING

Children's Dental Center

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Study Officials

• Macaire C Thiel, DDS MS

  Children's Hospital of Wisconsin, Pediatric Dental Residency Program Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Macaire C Thiel, DDS MS

CONTACT

9202842414; MThiel@chw.org

Christopher Niu, DDS

CONTACT

4142662040; CNiu@chw.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor (individual assessing radiographs for evidence of carious lesion progression or stabilization) will be masked. Due to the nature of the intervention (orthodontic band placement), the participant and care providers will not be able to be masked.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Dentist

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 4, 2020
• Study Start: September 3, 2020
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)