NCT04673097

Brief Summary

The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 10, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

December 19, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

October 10, 2020

Last Update Submit

December 12, 2020

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (11)

  • Color improvements

    Pre-treatment and post-treatment color changing (L\*A\*B values) of digital photographs using the Commission Internationale de l'Eclairage (CIE) system

    Change from 0 day, 1 month and 6 months

  • Patient self satisfaction

    Post-treatment patient satisfaction using the patient satisfaction scale

    Change from 0 day, 1 month and 6 months

  • Change in lesion status

    Post-treatment change in caries lesion status using ICDAS II

    Change from 0 day, 1 month and 6 months

  • Cracks of enamel.

    Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM

    Change from 0 day, 1 month and 6 months

  • Microbial composition.

    Pre-treatment and post-treatment microbial composition of plaque samples. Samples will be stored at -80 °C until DNA extractions will be performed and run the 16S rRNA sequencing.

    Change from 0 day, 1 month and 6 months

  • Effects on clinical parameter: sensitivity to percussion

    Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument.

    Change from 0 day, 1 month and 6 months

  • esthetic improvement

    Esthetic improvement through objective assessments using a visual analogue

    Change from 0 day, 1 month and 6 months

  • Patient esthetic self perception

    Pre-treatment esthetic self perception by the subjects using questionnaire

    Change from 0 day, 1 month and 6 months

  • change in lesion size

    Pre-treatment and post-treatment white spot lesion size

    Change from 0 day, 1 month and 6 months

  • fracture of enamel.

    Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM

    Change from 0 day, 1 month and 6 months

  • Effects on clinical parameter: prolonged response to hot or cold.

    Pre-treatment and post-treatment effects on response to hot or cold by cold test

    Change from 0 day, 1 month and 6 months

Study Arms (3)

Group 1

EXPERIMENTAL
Other: Icon® resin infiltration

Group 2

ACTIVE COMPARATOR
Other: MI paste plus

Group 3

ACTIVE COMPARATOR
Other: Icon® resin infiltrationOther: MI paste plus

Interventions

Icon® resin infiltrationOTHER

low viscosity resin that can flow through the pores in the enamel surface

Group 1Group 3
MI paste plusOTHER

s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.

Group 2Group 3

Eligibility Criteria

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

You may qualify if:

  • Patients who are willing and able to observe good oral hygiene and attend for the study visits.
  • Subjects with ≥1 visible and accessible early caries lesion present.
  • No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.

You may not qualify if:

  • Active carious lesions
  • Facial surface restorations
  • Deciduous teeth
  • Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia)
  • Intrinsic and extrinsic strains
  • Physically and mentally challenged volunteers
  • Patients with systemic diseases under medication
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, 32437, Saudi Arabia

Location

Central Study Contacts

jumanah aljishi

CONTACT

00966534282332jumanah.aljishi@gmail.com

Nawarah Alaseef

CONTACT

00966507083741Nawarah.alaseef@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dental intern

Study Record Dates

First Submitted

October 10, 2020

First Posted

December 17, 2020

Study Start

December 19, 2020

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

SA(1)