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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02912741
• Other study ID #: CEBD-CU-2016-09-209
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 20, 2016
• Last updated: September 21, 2016
• Start date: January 2017
• Est. completion date: May 2018

Study information

• Verified date: September 2016
• Source: Cairo University
• Contact: Shaimaa Mohammed Rohym, Master
• Phone: 01007374670
• Email: drshdentist[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: May 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 35 Years

Eligibility

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 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

Intervention

Drug:
• Vanish xt Extended Contact Varnish
resin modified glass- ionomer cement varnish applied as a thin layer coating and cured
• resin infiltration
low viscous light cure resin applied in layers and cured

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in caries lesion state	Diagnodent device	immediately, 1 day, 1week,1 month,3 month,6 month and1 year	Yes
Primary	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	Yes
Secondary	Change in color change	using vita easy shade device	immediately, 1 day, 1week,1 month,3 month,6 month and1 year	Yes