NCT05409742

Brief Summary

The study aims to evaluate postoperative pain and masseter muscle activity in a group of Egyptian children with carious primary molars treated with Hall Vs modified Hall Technique (with proximal and occlusal reduction).

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 4, 2022

Last Update Submit

June 4, 2022

Conditions

Keywords

Hall techniqueModified Hall techniqueStainless steel crowns

Outcome Measures

Primary Outcomes (1)

  • Masseter muscle activity measured by Electromyograph

    muscle activity will be measured following the cementation of the crown

    6 weeks

Study Arms (2)

Modified Hall technique

ACTIVE COMPARATOR
Diagnostic Test: Modified Hall technique

Hall Technique

EXPERIMENTAL
Diagnostic Test: Modified Hall technique

Interventions

The standard Hall technique was later modified with several modifications including occasional/rare use of anesthetic and about 1 mm proximal slice that the preformed metal crown fits without separation, and minimal occlusal reduction of the cusps

Hall TechniqueModified Hall technique

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 5-7 years with carious lower second primary molars
  • Both genders.
  • Systemically and mentally healthy.

You may not qualify if:

  • History of systemic or mental conditions.
  • Special health care needs who require pharmacological management before dental treatment.
  • Acute dental pain or trauma.
  • Extremely uncooperative children who require being treated under general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Cairo University

Cairo, EL-Manial, 11553, Egypt

Location

Central Study Contacts

Manal Ahmed El Sayed, Professor

CONTACT

Passant Nagi Abdelsamea, doctorate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2022

First Posted

June 8, 2022

Study Start

October 1, 2022

Primary Completion

December 31, 2022

Study Completion

September 1, 2023

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations