Effect of Light Curable Resin Modified Glass Ionomer Varnish on Non-Cavitated Proximal Carious Lesions' Progression

Summary

The standard-of-care preventive measures to stop early tooth decay from becoming worse is by fluoride application, diet counseling, and oral hygiene instructions. This standard way is not always successful. The purpose of this study is to compare standard-of-care preventive measures to stop further tooth decay to standard-of-care preventive measures in addition to a light curable resin modified glass ionomer (RMGI) varnish material (Vanish XT). The material is used for root surface sensitivity treatment, site specific protective coating for newly erupted teeth and other tooth surfaces including early tooth decay.

To be in this study the child must be five to eight years old, medically healthy, attending the Pediatric Dentistry Clinics in King Abdulaziz University Dental Hospital (KAUDH),diagnosed to have at least two primary molars and/ or first permanent molars with early-stage caries (using bitewing radiographs, near infrared digital imaging transilluminaton (NIDIT), and visual assessment), and willing to return for follow up visits. If the child is eligible and the parents agree to the participation of their child in this study, the researcher will review the child's personal and medical history.

The child's two included molars diagnosed with early-stage caries will be randomly assigned to one of two groups: Control Group: will receive standard-of-care preventive measures. Test Group: will receive RMGI varnish application plus the standard-of-care preventive measures. The child will be followed up at six months and 12 months. A dental examination will be done using the same methods used in the first examination to determine whether the caries has become deeper or not. The child may be withdrawn from the study at this point if the caries has become too deep and the tooth will then need a filling.

The child's medical status will be up-dated, reinforcement of oral hygiene instruction and diet counseling will be provided, and fluoride varnish application will be applied to all the teeth in both six and 12 months follow-ups.The RMGI varnish will be reapplied to the test teeth at the six months follow up.

Conditions

• Dental Caries
• Dental White Spot

Interventions

DEVICE

Light curable resin modified glass ionomer varnish

Treatment of non-cavitated proximal carious lesions with light curable resin modified glass ionomer varnish at initial and six-months follow-up visits, in addition, the patient will receive standard-of-care preventive measures, at initial, six-months follow-up, and 12-months follow-up visits.

OTHER

standard-of-care preventive measures

Patient will receive standard-of-care preventive measures which include application of 5% sodium fluoride topical varnish, oral hygiene instructions, and dietary counseling at initial, six-months follow-up, and 12-months follow-up visits

Sponsors & Collaborators

• King Abdulaziz University

  lead OTHER

Principal Investigators

• Najlaa M Alamoudi, BDS,MSc,DSc · King Abdulaziz University, Faculty of Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-11

Primary Completion

2019-07-31

Completion

2019-11-30

FDA Device

Yes

Countries

• Saudi Arabia

Study Locations