NCT04671134

Brief Summary

The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

December 8, 2020

Last Update Submit

December 11, 2020

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

  • state of lesions

    Digital scores

    6 months.

Secondary Outcomes (1)

  • shade of lesions

    6 months

Study Arms (2)

Biomimetic remineralizing agent

EXPERIMENTAL
Other: Biomimetic remineralizing agentOther: Resin Modified Glass Ionomer Varnish

Resin modified glass ionomer varnish

ACTIVE COMPARATOR
Other: Biomimetic remineralizing agentOther: Resin Modified Glass Ionomer Varnish

Interventions

Biomimetic remineralizing agentOTHER

Self-assempling peptide

Biomimetic remineralizing agentResin modified glass ionomer varnish
Resin Modified Glass Ionomer VarnishOTHER

Resin Modified Glass Ionomer Varnish

Biomimetic remineralizing agentResin modified glass ionomer varnish

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients included in this clinical trial were less than 30 years old.
  • Patients with good general health.
  • Patients who will agree to the consent and will commit to follow-up period.
  • Fully erupted anterior teeth with no cavitated lesions.

You may not qualify if:

  • Patients with any systemic disease that may affect normal healing.
  • Patient with bad oral hygiene.
  • Tetracycline or florosis staining.
  • Patients who could/would not participate in all times of follow-up.
  • Untreated periodontal disease was not allowed.
  • Active caries or defective Restorations in 6 anterior teeth.
  • Bleaching history
  • Patients participating in more than 1 dental study.
  • Patient received fluoride varnish before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, 11751, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 17, 2020

Study Start

June 1, 2017

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

EG(1)