NCT04479046

Brief Summary

Evaluation of PMMA pediatric crowns

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

December 27, 2019

Last Update Submit

July 16, 2020

Conditions

Decay, Dental

Outcome Measures

Primary Outcomes (2)

  • Gingival health

    Plaque index

    6 months

  • Crown survival

    Fracture

    6 months

Study Arms (3)

Stainless steel crowns

ACTIVE COMPARATOR

3M ESPE

Other: PMMA crowns

Zirconia crowns

EXPERIMENTAL

Nu Smile

Other: PMMA crowns

PMMA crowns

EXPERIMENTAL

Dental Direkt

Other: PMMA crowns

Interventions

PMMA crownsOTHER

New type of pediatric crowns

PMMA crownsStainless steel crownsZirconia crowns

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children included in the study should conform to the following criteria:
  • Aged 5-8 years old
  • Medically free
  • Patient should suffer from extensively decayed primary lower second molar that will undergo pulpotomy.
  • The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.

You may not qualify if:

  • Children with the following criteria will be totally excluded from the study:
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  • Children who are extremely uncooperative and difficult to manage.
  • Children suffering from any medical conditions that can't be managed in the clinic.
  • Teeth with decay extending beneath the free gingival margin.
  • Teeth that were grossly broken down, that cannot be restored.
  • Presence of uncontrolled bleeding.
  • Clinical or radiographic evidence of non-vitality such as presence of an abscess or a sinus, obvious discoloration, and premature hypermobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Heliopolis, Cairo Governorate, 11737, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 27, 2019

First Posted

July 21, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

June 1, 2019

Last Updated

July 21, 2020

Record last verified: 2020-07

Locations

EG(1)