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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03721198
Other study ID # RMGI Varnish-WSL prevention
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2019
Est. completion date October 2019

Study information

Verified date March 2019
Source Cairo University
Contact Mohamed Zidan, BDS
Phone 01157625577
Email Dr_mhmdzidan@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

evaluate the effect of a single application of Clinpro XT varnish on enamel demineralization adjacent to orthodontic brackets during fixed orthodontic treatment in comparison with acidulated phosphorus fluoride gel.

this study is to assess the durability of the results obtained from both materials (Clinpro XT Varnish- APF Gel) this study is to determine the degree of

patients' satisfaction after the use of both materials (Clinpro XT Varnish -

APF Gel)


Description:

This clinical study will be held in the orthodontic clinic, Faculty of dentistry, Cairo University, Egypt Principal investigator (MZ) will select and examine the patients according to the inclusion criteria.

Tooth preparation procedure:

Excessive saliva in Upper six anterior teeth will be removed by cotton rolls or by using an air syringe without excessive drying. Principal investigator (MZ) will take a photograph for each tooth using A Digital DSLR camera (canon 700d with lens 100 macro 2.8) and this photograph is T0(before application of the gel)

Intervention and comparator:

1. Bonding procedure before application of intervention and comparator

Upper six anterior teeth will be cleaned with pumice, rinsed and dried thoroughly. The area where the bracket is to be placed will be etched with a 37% orthophosphoric acid gel for 15 seconds and then rinsed with water. After rinsing, the enamel surface will be dried with compressed moisture and oil free air. A layer of primer will be applied to the tooth and bracket mesh. Adhesive paste will be applied to the base of the bracket and pressed firmly onto the tooth surface. Excess adhesive will be removed, and the adhesive light cured for 20 seconds.

2. Preparation of clinpro XT (intervention)

In upper right anterior teeth, the polished tooth surface is etched using 37% orthophosphoric acid gel. applied for 15 seconds over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin. Then, the surface is rinsed thoroughly by water spray and dried with compressed moisture and oil free air to remove the etchant. The paste and liquid components of the varnish are mixed on a paper pad for 10-15 seconds by a small plastic spatula. When the mix material appears glossy and smooth in consistency, it is applied as a thin layer over the etched enamel surface by a ball applicator. Care should be taken to avoid prolonged contact of uncured material with soft tissues.

If accidental contact occurred, the material is immediately wiped off with wet cotton roll. Then, the varnish is light cured with the visible light-curing unit for 20 s.Oral hygiene instruction will be given to the patient e.g. tooth brushing twice a day with fluoride toothpaste.

A photograph will be taken for the labial surface of each upper right anterior tooth using the same camera by the outcome assessor (MS) after 3 months (T1) and 6 months (T2) of orthodontic treatment.

3. Preparation of Acidulated Phosphorus Fluoride (Comparator):

Acidulated Phosphorus Fluoride gel will be applied directly over the labial enamel surface extending from gingival surface of the bracket to the free gingival margin using a small brush/swab to spread the gel over the surface. The gel will be left in place for four minutes then washed. Patients will be instructed not to rinse, eat, drink or smoke for the next 30 minutes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16
Est. completion date October 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patient indicating for fixed orthodontic treatment with healthy gingival and periodontal condition

Exclusion Criteria:

1. Presence of enamel hypoplasia or dental fluorosis.

2. Presence of tetracycline pigmentation.

3. Periodontal pocketing of 3mm or greater.

4. Presence of carious cavities.

5. Smokers.

6. Allergy to fluoride gel being used in study.

7. Patient that have systemic disease.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Acidulated phosphorous flouride
Acidulated phosphorous flouride is used to prevent white spot lesions
Other:
Resin modified glass ionomer varnish
Resin modified glass ionomer varnish is used to prevent white spot lesions

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Mohamed zidan Cairo University

Outcome

Type Measure Description Time frame Safety issue
Other Patient satisfaction: VAS APF Gel) Patient satisfaction using visual analogue scale A scale to assess the patient satisfaction A scale from 0 to 10 10 means fully satisfied by the results 0 means unsatisfied by the result 6 months
Primary Colour change Colour change using spectrophotometer 6 months
Secondary Colour stability Colour stability using spectrophotometer 6 months
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