Clinical trial NCT02912741: 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
Official title: Double Blinded Randomized Clinical Trial for Evaluation of Resin Modified Glass Ionomer Cement Versus Resin Infiltration in Treating White Spot Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: White Spot Lesions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 35
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in Patient satisfaction
timeFrame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
Secondary outcomes:
measure: Change in color change
timeFrame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
Other outcomes:
measure: Change in caries lesion state
timeFrame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
Locations:
Study officials:
affiliation: Cairo University
name: Ahmed Elkhadem, PhD
role: STUDY_CHAIR
References: