NCT04973761

Brief Summary

Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

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

March 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

July 17, 2021

Last Update Submit

August 2, 2021

Conditions

Caries

Outcome Measures

Primary Outcomes (1)

  • Oral health related quality of life

    Early Childhood Oral Health Impact Scale (ECOHIS).

    12 months

Study Arms (2)

Strip composite crowns

OTHER
Other: Strip composite crowns

Zirconium crowns

EXPERIMENTAL
Other: Zirconium crowns

Interventions

Zirconium crownsOTHER

Prefabricated pirmary anteroir teeth zirconium crowns

Zirconium crowns
Strip composite crownsOTHER

Strip composite crowns

Strip composite crowns

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy children Cariuos primary anteroir teeth Cooperative children

You may not qualify if:

  • children with systemic diseases Children with bad oral habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 17, 2021

First Posted

July 22, 2021

Study Start

March 1, 2018

Primary Completion

November 1, 2020

Study Completion

January 1, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Locations

EG(1)