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 Overview
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Brief Summary
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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
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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: Explain patient need toward aesthetic needs Digital photos for white spot lesions 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

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

Conditions
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White Spot Lesions

Intervention / Treatment
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* Drug: Vanish xt Extended Contact Varnish
* Drug: resin infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-Orthodontic patients included in this clinical trial toll age of 35 years. Patients with good general health. Patients who will agree to the consent and will commit to follow-up period. Fully erupted anterior teeth with no cavitated lesions. At least one spot lesion on each side in the same jaw Exclusion Criteria: Patients with any systemic disease that may affect normal healing. Patient with bad oral hygiene. Tetracycline or fluorsis staining. Patients who could/would not participate in all times of follow-up. Untreated periodontal disease was not allowed. Active caries or defective Restorations in 6 anterior teeth. Bleaching history Patients participating in more than 1 dental study. Patient received fluoride varnish during orthodontic treatment.

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vanish xt Extended Contact Varnish<br>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<br>* resin modified glass- ionomer cement varnish applied as a thin layer coating and cured<br>* Other names: Clinpro xt;|
| Active Comparator: Resin infiltration<br>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<br>* low viscous light cure resin applied in layers and cured<br>* Other names: ICON;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient satisfaction | using visual analogue scale ruler (0-100 mm) 0 refer to not satisfied at all,100 refer to total satisfied | immediately, 1 day, 1week,1 month,3 month,6 month and1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in color change | using vita easy shade device | immediately, 1 day, 1week,1 month,3 month,6 month and1 year |