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One Year Clinical Evaluation of White Spot Lesions Treated With Newly Introduced Resin Modified Glass Ionomer in Comparison to Resin Infiltration in Anterior Teeth Split Mouth Technique

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ClinicalTrials.gov Identifier: NCT02912741
Recruitment Status : Unknown
Verified September 2016 by Shaimaa Mohamed Mostafa Rohym, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Shaimaa Mohamed Mostafa Rohym, Cairo University

Brief Summary:
The aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral cavity and to overcome the high expensive cost in treating such clinical cases

Condition or disease Intervention/treatment Phase
White Spot Lesions Drug: Vanish xt Extended Contact Varnish Drug: resin infiltration Phase 2

Detailed Description:

Roles and responsibilities:

  • Shaimaa Mohammed (SH.M.): Operator and author.Specialist in Air-Force Specialized Hospital.
  • Mohamed Riad (M.R.): Main supervisor, data monitoring and auditing, Professor, Conservative Dentistry Department,Cairo University.
  • Asma Harhash(A.H.):Co-supervisor, outcome assessor and data collection, Associate Professor, Russian University.
  • Omnia Magdy Moustafa (O.M.): Baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents: Assistant lecturer, Conservative Dentistry Department , Faculty of Oral and Dental Medicine Cairo University.
  • Ghada Ahmed (G.A.): Data entry and auditing; Assistant lecturer, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Russian University.

Intervention:

A- Preoperative clinical assessment:

  1. Explain patient need toward aesthetic needs
  2. Digital photos for white spot lesions
  3. Recording number of white spot lesions and site. (SH.M.) will apply both materials at the same patient mouth (Split mouth technique) according to the manufacturer's instructions.

    • Intervention: resin modified glass ionomer cement varnish: Vanish™ xt Extended Contact Varnish (3M ESPE Dental)
    • Comparator: resin infiltration (Dental Milestones Guaranteed, Germany).

(A.H) and (SH.M) will assess the outcome measures through the follow up time: immediately after,1 day, 1 week,1 month,3 months, 6 months, 12 months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blinded Randomized Clinical Trial for Evaluation of Resin Modified Glass Ionomer Cement Versus Resin Infiltration in Treating White Spot Lesions
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Rashes

Arm Intervention/treatment
Experimental: Vanish xt Extended Contact Varnish
Vanish xt Extended Contact Varnish is a resin modified glass ionomer cement and fluoride varnish used to treat white spot lesions to be more resistant to early caries progression.
Drug: Vanish xt Extended Contact Varnish
resin modified glass- ionomer cement varnish applied as a thin layer coating and cured
Other Name: Clinpro xt

Active Comparator: Resin infiltration
Resin infiltration is a low viscous resin infiltrates into small pores of white spot lesions to block entrance of bacteria into dentinal tubules of the tooth and more resistant to early caries progression.
Drug: resin infiltration
low viscous light cure resin applied in layers and cured
Other Name: ICON




Primary Outcome Measures :
  1. Change in Patient satisfaction [ Time Frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year ]
    using visual analogue scale ruler (0-100 mm) 0 refer to not satisfied at all,100 refer to total satisfied


Secondary Outcome Measures :
  1. Change in color change [ Time Frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year ]
    using vita easy shade device


Other Outcome Measures:
  1. Change in caries lesion state [ Time Frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year ]
    Diagnodent device



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Post-Orthodontic patients included in this clinical trial toll age of 35 years.
  2. Patients with good general health.
  3. Patients who will agree to the consent and will commit to follow-up period.
  4. Fully erupted anterior teeth with no cavitated lesions.
  5. At least one spot lesion on each side in the same jaw

Exclusion Criteria:

  1. Patients with any systemic disease that may affect normal healing.
  2. Patient with bad oral hygiene.
  3. Tetracycline or fluorsis staining.
  4. Patients who could/would not participate in all times of follow-up.
  5. Untreated periodontal disease was not allowed.
  6. Active caries or defective Restorations in 6 anterior teeth.
  7. Bleaching history
  8. Patients participating in more than 1 dental study.
  9. Patient received fluoride varnish during orthodontic treatment.

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): NCT02912741


Contacts
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Contact: Shaimaa Mohammed Rohym, Master 01007374670 drshdentist@hotmail.com
Contact: Asmaa Harhash, PHD 01223325740 asmaaharhash@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Ahmed Elkhadem, PhD Cairo University
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Responsible Party: Shaimaa Mohamed Mostafa Rohym, Specialist in Air-Force Specialized Hospital, New Cairo, Cairo University
ClinicalTrials.gov Identifier: NCT02912741    
Other Study ID Numbers: CEBD-CU-2016-09-209
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases