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

White Spot Lesions Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesions

• NCT number: NCT02912741
• Study type: Interventional
• Source: Cairo University
• Contact: Shaimaa Mohammed Rohym, Master
• Phone: 01007374670
• Email: drshdentist@hotmail.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2017
• Completion date: May 2018