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
|Condition or disease||Intervention/treatment||Phase|
|White Spot Lesions||Drug: Vanish xt Extended Contact Varnish Drug: resin infiltration||Phase 2|
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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
- Change in color change [ Time Frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year ]using vita easy shade device
- Change in caries lesion state [ Time Frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year ]Diagnodent device
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
|Contact: Shaimaa Mohammed Rohym, Masterfirstname.lastname@example.org|
|Contact: Asmaa Harhash, PHDemail@example.com|
|Study Chair:||Ahmed Elkhadem, PhD||Cairo University|