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Trial record 9 of 1236 for:    tooth decay

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

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ClinicalTrials.gov Identifier: NCT03685058
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Najlaa Alamoudi, King Abdulaziz University

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 The child may be withdrawn from the study at this point if the caries has become too deep and the tooth will then need a filling.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


Condition or disease Intervention/treatment Phase
Dental Caries Dental White Spot Device: Light curable resin modified glass ionomer varnish Other: standard-of-care preventive measures Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: The Effect of Light Curable Resin Modified Glass Ionomer Varnish on Inhibiting the Progression of Non-Cavitated Proximal Carious Lesions: A Randomized Controlled Trial
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: The control group
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
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

Experimental: The test group
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
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 Name: Vanish™ XT Extended Contact Varnish

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




Primary Outcome Measures :
  1. Clinical progression of non-cavitated proximal carious lesions measured using ICDAS six months after treatment [ Time Frame: After six of 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.

  2. Clinical progression of non-cavitated proximal carious lesions measured using ICDAS 12 months after treatment [ Time Frame: After 12 months. ]
    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.

  3. Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs six months after treatment [ Time Frame: After six months ]
    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.

  4. Radiographic progression of non-cavitated proximal carious lesions assessed using bitewing radiographs 12 months after treatment [ Time Frame: After 12 months ]
    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.

  5. Progression of non-cavitated proximal carious lesions measured with NILT six months after treatment [ Time Frame: After six months ]
    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.

  6. Progression of non-cavitated proximal carious lesions measured with NILT 12 months after treatment [ Time Frame: After 12 months ]
    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.


Secondary Outcome Measures :
  1. The effect of plaque accumulation on the success rate of the treatment [ Time Frame: After 12 months ]
    To evaluate the effect of plaque accumulation on the success rate of light curable RMGI varnish and standard-of-care preventive measures in inhibiting the progression of non-cavitated proximal carious lesions in comparison to standard of care preventive measures only.

  2. The effect of gingival inflammation on the success rate of the treatment [ Time Frame: After 12 months ]
    To evaluate the effect of gingival inflammation on the success rate of light curable RMGI varnish and standard-of-care preventive measures in inhibiting the progression of non-cavitated proximal carious lesions in comparison to standard of care preventive measures only.

  3. he effect of the presence of adjacent restoration on the success rate of the treatment [ Time Frame: After 12 months ]
    To evaluate the effect of the presence of adjacent restoration on the success rate of light curable RMGI varnish and standard-of-care preventive measures in inhibiting the progression of non-cavitated proximal carious lesions in comparison to standard of care preventive measures only.

  4. The effect of caries severity on the success rate of the treatment [ Time Frame: After 12 months ]
    To evaluate the effect of caries severity on the success rate of light curable RMGI varnish and standard-of-care preventive measures in inhibiting the progression of non-cavitated proximal carious lesions in comparison to standard of care preventive measures only.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The subject's inclusion criteria:

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.

The tooth's inclusion criteria:

  1. 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.
  2. Presence of a tooth adjacent to the lesion.
  3. Normal tooth structure.
  4. Absence of tooth mobility.
  5. Tooth does not require restorative treatment.

Exclusion Criteria:

•The subject's exclusion criteria:

  • 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.

The tooth exclusion criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685058


Contacts
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Contact: Najlaa M Alamoudi, BDS,MSc,DSc 00966126402000 ext 23580 nalamoudi@kau.edu.sa
Contact: Jihan A Khan, BDS,MSc 00966126402000 ext 23580 jakhan@kau.edu.sa

Locations
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Saudi Arabia
King abulaziz University, Dental University Hospital Recruiting
Jeddah, P.O Box 80209, Saudi Arabia, 21589
Contact: Najlaa M Alamoudi, BDS,MSc,DSc    6400000 ext 20388    nalamoudi@kau.edu.sa   
Principal Investigator: Najla M Alamoudi, BDS,MSc,DSc         
Sub-Investigator: Eman A Elashiry, BDS,MSc,PhD         
Sub-Investigator: Jihan A Khan, BDS,MSc         
Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Najlaa M Alamoudi, BDS,MSc,DSc King Abdulaziz University, Faculty of Dentistry

Publications:

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Responsible Party: Najlaa Alamoudi, 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, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT03685058     History of Changes
Other Study ID Numbers: NAlamoudi
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Najlaa Alamoudi, King Abdulaziz University:
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
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Methamphetamine
Sodium Fluoride
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Cariostatic Agents
Protective Agents