Masseter Muscle Activity and Post-operative Pain in a Group of Egyptian Children Treated With Hall Technique Vs Modified Hall Technique

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05409742

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Masseter Muscle Activity	Diagnostic Test: Modified Hall technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Diagnostic

Official Title:

Masseter Muscle Activity and Post-Operative Pain in A Group of Egyptian Children With Carious Primary Molars Treated With Hall Vs Modified Hall Technique: A Randomised Clinical Trial

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Modified Hall technique	Diagnostic Test: Modified Hall technique 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
Experimental: Hall Technique	Diagnostic Test: Modified Hall technique 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

Arm

Intervention/Treatment

Active Comparator: Modified Hall technique

Diagnostic Test: Modified Hall technique

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

Experimental: Hall Technique

Diagnostic Test: Modified Hall technique

Outcome Measures

Primary Outcome Measures

Masseter muscle activity measured by Electromyograph [6 weeks]
muscle activity will be measured following the cementation of the crown

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry Cairo University	Cairo	EL-Manial	Egypt	11553

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Adel Abdelazim Abdelsayed, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05409742

Other Study ID Numbers:

PEDO 4-8-3

First Posted:

Jun 8, 2022

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Adel Abdelazim Abdelsayed, Principal Investigator, Cairo University

Hall technique

Modified Hall technique

Stainless steel crowns

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jun 8, 2022