NCT05485272

Brief Summary

To evaluate the clinical performance of High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) in deep class I carious lesions, over a period of one year follow-up. The null hypothesis tested in this study, that in deep class I carious lesions, the High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) will show the same clinical performance.

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
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

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

Study Start

First participant enrolled

February 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

July 30, 2022

Last Update Submit

August 1, 2022

Conditions

Carious Lesion

Outcome Measures

Primary Outcomes (1)

  • Biological Properties: (Postoperative hyper-sensitivity)

    will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by patient interviewing

    12 Months.

Secondary Outcomes (2)

  • Functional Properties: (Radiographic examination and Patient's view) (Radiographic examination, and Patient's view)

    12 months.

  • Esthetic: Tooth Color

    12 months.

Study Arms (3)

Intervention 1

EXPERIMENTAL

Silver Diamine Fluoride combined with Potassium Iodide (Riva Star), under High-Viscosity Glass Ionomer (EQUIA).

Other: Silver Diamine Fluoride combined with Potassium Iodide.

Intervention 2

EXPERIMENTAL

Silver Diamine Fluoride (SDF), under High-Viscosity Glass Ionomer (EQUIA).

Other: Silver Diamine Fluoride.

The comparator

ACTIVE COMPARATOR

High-Viscosity Glass Ionomer (EQUIA).

Other: High-Viscosity Glass Ionomer.

Interventions

Silver Diamine Fluoride combined with Potassium Iodide.OTHER

Riva Star, Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia.

Also known as: Riva Star.
Intervention 1
Silver Diamine Fluoride.OTHER

A clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride.

Also known as: SDF.
Intervention 2
High-Viscosity Glass Ionomer.OTHER

A Glass Hybrid material.

Also known as: EQUIA
The comparator

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with deep class I carious lesions in molars, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin).
  • Adults males or females.
  • Age: 18-40 years old.
  • Good Oral hygiene.
  • Co-operative patients, approving to participate in the study.
  • Teeth planned to be restored should be vital.
  • Presence of favorable occlusion.

You may not qualify if:

  • Patients having severe systemic diseases, allergies, or adverse medical histories.
  • Patients complaining of sever or active periodontal disease.
  • Lack of compliance.
  • Teeth diagnosed with irreversible pulpitis.
  • Non vital teeth.
  • Heavy occlusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Potassium Iodidesilver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

IodidesIodine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Shorouk H Helmy

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shorouk H Helmy, Master's

CONTACT

00201015775110shorouk.helmy@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The operator will not be blinded due to differences between both materials.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A 3-arm randomized clinical trial. Randomization will be done according to a check list including the number of participants divided into 3 groups of 14 patients (42 total) according to interventions/Control assessment methods.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Master's Student

Study Record Dates

First Submitted

July 30, 2022

First Posted

August 3, 2022

Study Start

February 1, 2022

Primary Completion

September 10, 2022

Study Completion

March 2, 2023

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

after 1 year.

Locations

EG(1)