NCT05645029

Brief Summary

to investigate the effect of modifying GIC with different formulations on the antibacterial activity and clinical performance in reference to unmodified glass ionomer restorative materials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

December 1, 2022

Last Update Submit

February 2, 2024

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • clinical performance

    the clinical performance of different restorations will be evaluated by USPHS evaluation criteria

    9 months

Secondary Outcomes (1)

  • antibacterial effect

    9 months

Study Arms (3)

glass ionomer-chlorhexidine

EXPERIMENTAL
Other: glass ionomer-chlorhexidine

glass ionomer -titanium dioxide powder.

EXPERIMENTAL
Other: glass ionomer-titanium dioxide powder

glass ionomer

ACTIVE COMPARATOR
Other: glass ionomer

Interventions

glass ionomer-chlorhexidineOTHER

chlorhexidine will be added to glass ionomer

glass ionomer-chlorhexidine
glass ionomer-titanium dioxide powderOTHER

titanium dioxide will be added to glass ionomer

glass ionomer -titanium dioxide powder.
glass ionomerOTHER

glass ionomer will be used without any additives

glass ionomer

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The teeth will be primary molars selected from patients presented to the outpatient clinic that are
  • Healthy patients.
  • Children having at least one primary molar with only occlusal caries having dentine lesions (ADA caries classification system mostly 1 or 2 please check)
  • Dentine caries must be apparent visually or radiographically

You may not qualify if:

  • Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis.
  • Patients with history of active para-functional oral habits, xerostomia.
  • Patients who will have difficulties in cooperating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry .Ain shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Interventions

glass ionomer

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
assistant professor

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

November 15, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)