Effectiveness of Using (Vanish XT) in Prevention of Occlusal Caries: a RCT

NCT04579536 | Unknown DMC

• 1 other identifier: Alaa Baik
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the continuous effort to prevent and treat dental caries, it continues to be one of the most common chronic diseases in both children and adults. Prevention and minimally intervention treatment by early detection of the lesion are becoming the new philosophy in managing dental caries. The prevalence of pit and fissure caries was found to be 90% of all dental caries in permanent molars. Moreover, the risk of caries development is higher soon after the tooth had erupted. The purpose of the current study is; to evaluate the effectiveness of a resin-modified glass ionmer cement (Vanish XT) varnish in the prevention of occlusal caries and compare it to a fluoride varnish in newly erupted first permanent molars.

Conditions

Caries Prevention

Keywords

occlusal caries; Vanish XT varnish; Clinpro XT varnish; Light curable resin modified glass ionomer varnish; deep pits and fissures; newly erupted permanent first molars

Outcome Measures

Primary Outcomes (4)

• caries development

  To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.

  3 months

• caries development

  To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.

  6 months

• caries development

  To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.

  12 months

• caries development

  To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.

  18 months

Study Arms (2)

Study group

EXPERIMENTAL

This is the study group; it will consist of 84 first permanent molars. These molars will be sealed using light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA). reapplication will be done after 3,6, 12, and 18 months.

Other: Light curable resin modified glass ionomer varnish

Control group

OTHER

This group will consist of 84 first permanent molars. These molars will receive 5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA). These molars will serve as a control group. reapplication will be done after 3,6, 12, and 18 months.

Other: Vanish White Varnish

Interventions

Light curable resin modified glass ionomer varnish OTHER

Light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used to seal 84 first permanent molars at baseline, 3, 6, 12 and 18 months.

Also known as: Vanish™ XT Extended Contact Varnish

Study group

Vanish White Varnish OTHER

5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used on 84 first permanent molars at baseline, 3, 6, 12 and 18 months.

Control group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children having no history of any systemic condition.
• Children must have all four first permanent molar.
• Children must have at least one pair of contralateral newly erupted first permanent molars free from caries.
• Teeth with deep pits and fissures (at high risk for caries).
• These molars should be free of caries, restorations, sealants, fracture, hypoplasia, or cracks.
• High caries risk children.

You may not qualify if:

• Children whom their parents refused to sign the consent form.
• Children older than 9 years old.
• Medically compromised children.
• Children having discolored grooves, restored, caries, or hypoplastic first permanent molars.
• Children having proximal caries in first permanent molars.
• Children whose antagonist teeth were extracted or not erupted.
• Children with a known acrylate allergy.
• Uncooperative children.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King abulaziz University, Dental University Hospital

Jeddah, P.O Box 80209, 21589, Saudi Arabia

RECRUITING

Related Publications (1)

• Baik A, Alamoudi N, Felemban O, El-Housseiny A, Almabadi E, Baik K, Altuwirqi A, Masoud I. Prevention of occlusal caries using VanishTM XT: an 18-month follow-up randomized clinical trial. BMC Oral Health. 2024 Nov 1;24(1):1328. doi: 10.1186/s12903-024-05095-8.

  PMID: 39487418 DERIVED

Central Study Contacts

Alaa M Baik, BDS,MSc

CONTACT

00966 2 640-1000; ambaik@kau.edu.sa

Najlaa M Alamoudi, BDS,MSc,DSc

CONTACT

00966 2 640-1000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blinding. Because of the nature of the material, the investigator who will apply the material to the occlusal surfaces will not be blinded to the group allocation. However, the investigators who will perform the clinical visual examination and the radiographic examination will be blinded to which group the teeth they are evaluating belongs. In addition, the statistician will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: paediatric dentist specialist

Model Details: The design of the study is a split-mouth, randomized controlled clinical trial in which the teeth are randomly assigned to be either in the test group or the control group in a 1:1 ratio. The control group: will be treated with 5% sodium fluoride (NaF) white varnish, oral hygiene instruction, and dietary counseling. The test group: will be treated with light curable resin modified glass ionomer (RMGI) varnish.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 8, 2020
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: July 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)