NCT02912741

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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 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

Conditions

• White Spot Lesions

Interventions

Type	Name	Description
DRUG	Vanish xt Extended Contact Varnish	resin modified glass- ionomer cement varnish applied as a thin layer coating and cured
DRUG	resin infiltration	low viscous light cure resin applied in layers and cured

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-01-01
• Completion: 2018-05-01
• First posted: 2016-09-23
• Last updated: 2016-09-23