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

NCT03685058 | Unknown DMC FDA Device

• 1 other identifier: NAlamoudi
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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 The child may be withdrawn from the study at this point if the caries has become too deep and the tooth will then need a filling.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

Keywords

Initial caries treatment; Non-cavitated caries treatment; Incipient caries treatment; Proximal caries; Primary teeth; Light curable resin modified glass ionomer varnish; Vanish XT varnish; Clinpro XT varnish; Dental white spot lesions

Outcome Measures

Primary Outcomes (6)

• Clinical progression of non-cavitated proximal carious lesions measured using ICDAS six months after treatment

  To evaluate the clinical progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured using the ICDAS after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months.

  After six of treatment

• Clinical progression of non-cavitated proximal carious lesions measured using ICDAS 12 months after treatment

  To evaluate the clinical progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured using the ICDAS after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months.

  After 12 months.

• Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs six months after treatment

  To evaluate the radiographic progression of non-cavitated proximal carious lesions in primary molars and first permanent molars assessed by examination of bitewing radiographs after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months.

  After six months

• Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs 12 months after treatment

  To evaluate the radiographic progression of non-cavitated proximal carious lesions in primary molars and first permanent molars assessed by examination of bitewing radiographs after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months.

  After 12 months

• Progression of non-cavitated proximal carious lesions measured with NILT six months after treatment

  To evaluate the progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured with NILT after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after six months.

  After six months

• Progression of non-cavitated proximal carious lesions measured with NILT 12 months after treatment

  To evaluate the progression of non-cavitated proximal carious lesions in primary molars and first permanent molars measured with NILT after treatment with light curable RMGI varnish in addition to standard-of-care preventive measures compared to standard-of-care preventive measures alone after 12 months.

  After 12 months

Secondary Outcomes (4)

• The effect of plaque accumulation on the success rate of the treatment

  After 12 months

• The effect of gingival inflammation on the success rate of the treatment

  After 12 months

• he effect of the presence of adjacent restoration on the success rate of the treatment

  After 12 months

• The effect of caries severity on the success rate of the treatment

  After 12 months

Study Arms (2)

The control group

ACTIVE COMPARATOR

A total of 88 non-cavitated proximal carious lesions treated with standard-of-care preventive measures which include application of 5% sodium fluoride topical varnish (Vanish 5% Sodium Fluoride White Varnish with Tri-Calcium Phosphate, 3M ESPE, St. Paul, MN, U.S.A.), oral hygiene instruction, and dietary counseling applied at initial, six-months follow-up, and 12-months follow-up visits.

Other: standard-of-care preventive measures

The test group

EXPERIMENTAL

Intervention: A total of 88 non-cavitated proximal carious lesions treated with light curable resin modified glass ionomer varnish (Vanish™ XT Extended Contact Varnish, 3M ESPE, St. Paul, MN, U.S.A.) at initial and six-months follow-up visits. In addition to, standard-of-care preventive measures, applied at initial, six-months follow-up, and 12-months follow-up visits.

Device: Light curable resin modified glass ionomer varnish; Other: standard-of-care preventive measures

Interventions

Light curable resin modified glass ionomer varnish DEVICE

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.

Also known as: Vanish™ XT Extended Contact Varnish

The test group

standard-of-care preventive measures OTHER

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

The control group; The test group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child has at least two matched bilateral primary molars and/or first permanent molars with proximal carious lesions in the same surfaces in enamel or outer dentin third as by bitewing radiographic examination and are non-cavitated by visual examination.
• Their ages are five to eight years.
• Healthy.
• No known allergies to any of the components of the dental materials used in the study.
• The parents are willing to commit to the follow-up visits.
• Child is generally cooperative for dental treatment.
• Primary molar and/or first permanent molars with a proximal carious lesion in enamel or outer dentin third assessed by bitewing radiographic examination and that is found to be non-cavitated after ICDAS visual examination.
• Presence of a tooth adjacent to the lesion.
• Normal tooth structure.
• Absence of tooth mobility.
• Tooth does not require restorative treatment.

You may not qualify if:

• Children with a medical history of a chronic disease.
• Children who have abnormalities that affect tooth structure.
• The need of sedation or general anesthesia for dental treatment.
• Primary molar and/or first permanent molars with a proximal carious lesion extending beyond the outer dentin third assessed by bitewing radiographic examination.
• Primary molar and/or first permanent molars with a proximal carious lesion that is cavitated assessed by ICDAS visual examination.
• Non-cavitated proximal carious lesion on the mesial of the first primary molars because the contact area with the primary canine is narrow and the possible presence of the primate space.
• Distal surfaces of the first permanent molars because there is no contact with the second permanent molar (does not erupt in this age group).

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 (12)

• Mehta A, Paramshivam G, Chugh VK, Singh S, Halkai S, Kumar S. Effect of light-curable fluoride varnish on enamel demineralization adjacent to orthodontic brackets: an in-vivo study. Am J Orthod Dentofacial Orthop. 2015 Nov;148(5):814-20. doi: 10.1016/j.ajodo.2015.05.022.

  PMID: 26522042 BACKGROUND

• Young DA, Novy BB, Zeller GG, Hale R, Hart TC, Truelove EL; American Dental Association Council on Scientific Affairs; American Dental Association Council on Scientific Affairs. The American Dental Association Caries Classification System for clinical practice: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2015 Feb;146(2):79-86. doi: 10.1016/j.adaj.2014.11.018.

  PMID: 25637205 BACKGROUND

• Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.

  PMID: 15897335 BACKGROUND

• Sochtig F, Hickel R, Kuhnisch J. Caries detection and diagnostics with near-infrared light transillumination: clinical experiences. Quintessence Int. 2014 Jun;45(6):531-8. doi: 10.3290/j.qi.a31533.

  PMID: 24618570 BACKGROUND

• Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35. doi: 10.2341/06-63.

  PMID: 17555173 BACKGROUND

• GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.

  PMID: 14076341 BACKGROUND

• Weyant RJ, Tracy SL, Anselmo TT, Beltran-Aguilar ED, Donly KJ, Frese WA, Hujoel PP, Iafolla T, Kohn W, Kumar J, Levy SM, Tinanoff N, Wright JT, Zero D, Aravamudhan K, Frantsve-Hawley J, Meyer DM; American Dental Association Council on Scientific Affairs Expert Panel on Topical Fluoride Caries Preventive Agents. Topical fluoride for caries prevention: executive summary of the updated clinical recommendations and supporting systematic review. J Am Dent Assoc. 2013 Nov;144(11):1279-91. doi: 10.14219/jada.archive.2013.0057.

  PMID: 24177407 BACKGROUND

• Guideline on Caries-risk Assessment and Management for Infants, Children, and Adolescents. Pediatr Dent. 2016 Oct;38(6):142-149. No abstract available.

  PMID: 27931452 BACKGROUND

• Espelid I, Tveit AB. Clinical and radiographic assessment of approximal carious lesions. Acta Odontol Scand. 1986 Feb;44(1):31-7. doi: 10.3109/00016358609041295.

  PMID: 3456691 BACKGROUND

• Martignon S, Ekstrand KR, Ellwood R. Efficacy of sealing proximal early active lesions: an 18-month clinical study evaluated by conventional and subtraction radiography. Caries Res. 2006;40(5):382-8. doi: 10.1159/000094282.

  PMID: 16946605 BACKGROUND

• Bagher SM, Hegazi FM, Finkelman M, Ramesh A, Gowharji N, Swee G, Felemban O, Loo CY. Radiographic Effectiveness of Resin Infiltration in Arresting Incipient Proximal Enamel Lesions in Primary Molars. Pediatr Dent. 2018 May 15;40(3):195-200.

  PMID: 29793566 BACKGROUND

• Felemban OM, Khan JA, Alamoudi NM, El-Ashiry EA, Bagher SM. Perception of Pain With Bitewing, DIAGNOcam, and Teeth Separation Amongst Children. Int Dent J. 2024 Jun;74(3):631-637. doi: 10.1016/j.identj.2023.11.002. Epub 2024 Jan 12.

  PMID: 38216389 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Najlaa M Alamoudi, BDS,MSc,DSc

  King Abdulaziz University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Najlaa M Alamoudi, BDS,MSc,DSc

CONTACT

00966126402000; nalamoudi@kau.edu.sa

Jihan A Khan, BDS,MSc

CONTACT

00966126402000; jakhan@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Because of the nature of the study, the investigator who will apply the treatment will not be blind to the group allocation of the lesion. Yet, the investigators who will evaluate the radiographs, DIAGNOcam images, and perform the visual examination will be blinded to which group the lesion they are evaluating belongs. In addition, the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Pediatric Dentistry Department, Medical Director, KAU-DH Program Director, Post Grad Studies for Master and PhD programs Program Director,of Saudi Commission for Health Specialities, Faculty of Dentistry- King Abdulaziz University

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

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: September 26, 2018
• Study Start: January 11, 2018
• Primary Completion: July 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

SA (1)