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RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment

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ClinicalTrials.gov Identifier: NCT03721198
Recruitment Status : Unknown
Verified March 2019 by Mohamed zidan, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 26, 2018
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Mohamed zidan, Cairo University

Study Description
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Brief Summary:

evaluate the effect of a single application of Clinpro XT varnish on enamel demineralization adjacent to orthodontic brackets during fixed orthodontic treatment in comparison with acidulated phosphorus fluoride gel.

this study is to assess the durability of the results obtained from both materials (Clinpro XT Varnish- APF Gel) this study is to determine the degree of

patients' satisfaction after the use of both materials (Clinpro XT Varnish -

APF Gel)


Condition or disease Intervention/treatment Phase
White Spot Lesion of Tooth Combination Product: Acidulated phosphorous flouride Other: Resin modified glass ionomer varnish Not Applicable

Detailed Description:

This clinical study will be held in the orthodontic clinic, Faculty of dentistry, Cairo University, Egypt Principal investigator (MZ) will select and examine the patients according to the inclusion criteria.

Tooth preparation procedure:

Excessive saliva in Upper six anterior teeth will be removed by cotton rolls or by using an air syringe without excessive drying. Principal investigator (MZ) will take a photograph for each tooth using A Digital DSLR camera (canon 700d with lens 100 macro 2.8) and this photograph is T0(before application of the gel)

Intervention and comparator:

  1. Bonding procedure before application of intervention and comparator

    Upper six anterior teeth will be cleaned with pumice, rinsed and dried thoroughly. The area where the bracket is to be placed will be etched with a 37% orthophosphoric acid gel for 15 seconds and then rinsed with water. After rinsing, the enamel surface will be dried with compressed moisture and oil free air. A layer of primer will be applied to the tooth and bracket mesh. Adhesive paste will be applied to the base of the bracket and pressed firmly onto the tooth surface. Excess adhesive will be removed, and the adhesive light cured for 20 seconds.

  2. Preparation of clinpro XT (intervention)

    In upper right anterior teeth, the polished tooth surface is etched using 37% orthophosphoric acid gel. applied for 15 seconds over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin. Then, the surface is rinsed thoroughly by water spray and dried with compressed moisture and oil free air to remove the etchant. The paste and liquid components of the varnish are mixed on a paper pad for 10-15 seconds by a small plastic spatula. When the mix material appears glossy and smooth in consistency, it is applied as a thin layer over the etched enamel surface by a ball applicator. Care should be taken to avoid prolonged contact of uncured material with soft tissues.

    If accidental contact occurred, the material is immediately wiped off with wet cotton roll. Then, the varnish is light cured with the visible light-curing unit for 20 s.Oral hygiene instruction will be given to the patient e.g. tooth brushing twice a day with fluoride toothpaste.

    A photograph will be taken for the labial surface of each upper right anterior tooth using the same camera by the outcome assessor (MS) after 3 months (T1) and 6 months (T2) of orthodontic treatment.

  3. Preparation of Acidulated Phosphorus Fluoride (Comparator):

Acidulated Phosphorus Fluoride gel will be applied directly over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin using a small brush/swab to spread the gel over the surface. The gel will be left in place for four minutes then washed. Patients will be instructed not to rinse, eat, drink or smoke for the next 30 minutes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split mouth technique
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Resin-modified Glass Ionomer Varnish Versus Acidulated Phosphorus Fluoride Gel in Prevention of White Spot Lesions During Comprehensive Orthodontic Treatment: (Split Mouth Randomized Clinical Trial)(A Comparative Study)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia Rashes
Drug Information available for: Phosphorus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acidulated phosphorous flouride
Acidulated phosphorous flouride used once at the first of the study
 Combination Product: Acidulated phosphorous flouride
Acidulated phosphorous flouride is used to prevent white spot lesions
Other Name: APF
Experimental: Resin modified glass ionomer varnish
Resin modified glass ionomer varnish (CLINPRO XT ) is used once at the first of the study only
 Other: Resin modified glass ionomer varnish
Resin modified glass ionomer varnish is used to prevent white spot lesions
Other Name: CLINPRO XT


Outcome Measures
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Primary Outcome Measures :
  1. Colour change [ Time Frame: 6 months ]
    Colour change using spectrophotometer


Secondary Outcome Measures :
  1. Colour stability [ Time Frame: 6 months ]
    Colour stability using spectrophotometer


Other Outcome Measures:
  1. Patient satisfaction: VAS APF Gel) [ Time Frame: 6 months ]
    Patient satisfaction using visual analogue scale A scale to assess the patient satisfaction A scale from 0 to 10 10 means fully satisfied by the results 0 means unsatisfied by the result


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient indicating for fixed orthodontic treatment with healthy gingival and periodontal condition

Exclusion Criteria:

  1. Presence of enamel hypoplasia or dental fluorosis.
  2. Presence of tetracycline pigmentation.
  3. Periodontal pocketing of 3mm or greater.
  4. Presence of carious cavities.
  5. Smokers.
  6. Allergy to fluoride gel being used in study.
  7. Patient that have systemic disease.
Contacts and Locations
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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): NCT03721198


Contacts
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Contact: Mohamed Zidan, BDS 01157625577 Dr_mhmdzidan@yahoo.com

Sponsors and Collaborators
Mohamed zidan
Cairo University
Investigators
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Study Chair: mohamed Saied orthodontic department
More Information
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Responsible Party: Mohamed zidan, Principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03721198    
Other Study ID Numbers: RMGI Varnish-WSL prevention
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
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: No