Effectiveness of Resin-Modified Glass Ionomer Varnish in Preventing White Spot Lesions in Fixed Appliance Orthodontia

NCT03711097 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 0548-18-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective study to determine the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a preventative material placed on teeth. The RMGI will be applied at the initial bonding appointment when braces are put on. RMGI will be applied to some participant's teeth while others will not receive the varnish treatment. Patients will be given standardized oral hygiene instructions. At six months, the RMGI will be reapplied to the same teeth that received the original RMGI application. The development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Participants will be examined at 3-month intervals for a total of nine months to one year to determine if application of RMGI during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• Development of White Spot Lesion on the Labial Surface of the Upper Central and/or Lateral Incisors

  The development of white spot lesion in subjects will be determined by photographs that are evaluated for white spot lesions by experienced orthodontists as well as by objectively measuring the level of demineralization of the teeth based on dental scanning technology (The Canary System). The Canary System gives a numerical score based on the level of demineralization of the tooth and indicates if demineralization is progressing or improving over time.

  6-9 months

Study Arms (2)

Control

NO INTERVENTION

Upper left or right central and lateral incisor

Varnish Intervention

EXPERIMENTAL

Upper central and lateral incisor contralateral to control upper central and lateral incisor

Drug: Vanish XT Dental Varnish

Interventions

Vanish XT Dental Varnish DRUG

Varnish will be applied to the front surface of the intervention upper central and lateral incisors

Also known as: resin-modified glass ionomer

Varnish Intervention

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate in research project
• Age ≥ 10 years old, fully erupted maxillary central and lateral incisors
• treatment time with fixed appliances estimated to be at least 6 months

You may not qualify if:

• Presence of peg lateral maxillary incisors
• Presence of one or more significant WSLs on maxillary incisors prior to orthodontic therapy
• Restorations covering a significant portion of the labial surfaces of the maxillary incisors
• Unerupted maxillary incisors, presence of uncontrolled caries
• Craniofacial Syndromic patients and patients with cleft lip and/or palate
• Pregnant or breast-feeding patients

Sponsors & Collaborators

• University of Nebraska: lead
• 3M: collaborator

Study Officials

• Brad Herman, DDS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth study

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 18, 2018
• Study Start: April 22, 2019
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share