NCT03721198

Brief 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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

October 22, 2018

Last Update Submit

March 9, 2019

Conditions

White Spot Lesion of Tooth

Outcome Measures

Primary Outcomes (1)

  • Colour change

    Colour change using spectrophotometer

    6 months

Secondary Outcomes (1)

  • Colour stability

    6 months

Other Outcomes (1)

  • Patient satisfaction: VAS APF Gel)

    6 months

Study Arms (2)

Acidulated phosphorous flouride

ACTIVE COMPARATOR

Acidulated phosphorous flouride used once at the first of the study

Combination Product: Acidulated phosphorous flouride

Resin modified glass ionomer varnish

EXPERIMENTAL

Resin modified glass ionomer varnish (CLINPRO XT ) is used once at the first of the study only

Other: Resin modified glass ionomer varnish

Interventions

Acidulated phosphorous flourideCOMBINATION_PRODUCT

Acidulated phosphorous flouride is used to prevent white spot lesions

Also known as: APF
Acidulated phosphorous flouride
Resin modified glass ionomer varnishOTHER

Resin modified glass ionomer varnish is used to prevent white spot lesions

Also known as: CLINPRO XT
Resin modified glass ionomer varnish

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Presence of enamel hypoplasia or dental fluorosis.
  • Presence of tetracycline pigmentation.
  • Periodontal pocketing of 3mm or greater.
  • Presence of carious cavities.
  • Smokers.
  • Allergy to fluoride gel being used in study.
  • Patient that have systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • mohamed Saied

    orthodontic department

    STUDY CHAIR

Central Study Contacts

Mohamed Zidan, BDS

CONTACT

01157625577Dr_mhmdzidan@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: split mouth technique
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 26, 2018

Study Start

March 1, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03