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

NCT ID: NCT02912741

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vanish xt Extended Contact Varnish

Intervention Type: DRUG

resin modified glass- ionomer cement varnish applied as a thin layer coating and cured

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.

Group Type: ACTIVE_COMPARATOR

resin infiltration

Intervention Type: DRUG

low viscous light cure resin applied in layers and cured

Interventions

Vanish xt Extended Contact Varnish

resin modified glass- ionomer cement varnish applied as a thin layer coating and cured

Intervention Type: DRUG

resin infiltration

low viscous light cure resin applied in layers and cured

Intervention Type: DRUG

Other Intervention Names

Clinpro xt; ICON

Eligibility Criteria

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.

• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohamed Mostafa Rohym

Specialist in Air-Force Specialized Hospital, New Cairo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Elkhadem, PhD

Role: STUDY_CHAIR

Cairo University

Central Contacts

Shaimaa Mohammed Rohym, Master

Role: CONTACT

drshdentist@hotmail.com

01007374670

Asmaa Harhash, PHD

Role: CONTACT

asmaaharhash@yahoo.com

01223325740

Other Identifiers

CEBD-CU-2016-09-209

Identifier Type: -

Identifier Source: org_study_id