Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments

NCT ID: NCT04673097

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-19

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

White Spot Lesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Group Type EXPERIMENTAL

Icon® resin infiltration

Intervention Type OTHER

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

Group 2

Group Type ACTIVE_COMPARATOR

MI paste plus

Intervention Type OTHER

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

Group 3

Group Type ACTIVE_COMPARATOR

Icon® resin infiltration

Intervention Type OTHER

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

MI paste plus

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Icon® resin infiltration

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

Intervention Type OTHER

MI paste plus

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jumanah Aljishi

Dental intern

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Imam Abdulrahman Bin Faisal University

Dammam, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

jumanah aljishi

Role: CONTACT

Phone: 00966534282332

Email: [email protected]

Nawarah Alaseef

Role: CONTACT

Phone: 00966507083741

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IAU_resin

Identifier Type: -

Identifier Source: org_study_id