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

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

Study Overview

• Status: Unknown
• Conditions: White Spot Lesions
• Intervention / Treatment: Drug: Vanish xt Extended Contact Varnish; Drug: resin infiltration

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

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Post-Orthodontic patients included in this clinical trial toll age of 35 years.
2. Patients with good general health.
3. Patients who will agree to the consent and will commit to follow-up period.
4. Fully erupted anterior teeth with no cavitated lesions.
5. At least one spot lesion on each side in the same jaw

Exclusion Criteria:

1. Patients with any systemic disease that may affect normal healing.
2. Patient with bad oral hygiene.
3. Tetracycline or fluorsis staining.
4. Patients who could/would not participate in all times of follow-up.
5. Untreated periodontal disease was not allowed.
6. Active caries or defective Restorations in 6 anterior teeth.
7. Bleaching history
8. Patients participating in more than 1 dental study.
9. Patient received fluoride varnish during orthodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: ICON

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caries lesion state	Diagnodent device	immediately, 1 day, 1week,1 month,3 month,6 month and1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Ahmed Elkhadem, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2016-09-209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED