Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Double Blinded Randomized Clinical Trial for Evaluation of Resin Modified Glass Ionomer Cement Versus Resin Infiltration in Treating White Spot Lesions

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

Detailed Summary:

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).

    Sponsor: Cairo University

    Current Primary Outcome: 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


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Change in color change [ Time Frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year ]

    using vita easy shade device


    Original Secondary Outcome: Same as current

    Information By: Cairo University

    Dates:
    Date Received: September 20, 2016
    Date Started: January 2017
    Date Completion: May 2018
    Last Updated: September 21, 2016
    Last Verified: September 2016