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

Primary Purpose

Masseter Muscle Activity

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Modified Hall technique

About this trial

This is an interventional diagnostic trial for Masseter Muscle Activity focused on measuring Hall technique, Modified Hall technique, Stainless steel crowns

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Faculty of dentistry Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Modified Hall technique

Hall Technique

Arm Description

Outcomes

Primary Outcome Measures

Masseter muscle activity measured by Electromyograph

muscle activity will be measured following the cementation of the crown

Secondary Outcome Measures

Full Information

NCT ID

NCT05409742

First Posted

June 4, 2022

Last Updated

June 4, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05409742

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Masseter Muscle Activity

Keywords

Hall technique, Modified Hall technique, Stainless steel crowns

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Modified Hall technique

Arm Type

Active Comparator

Arm Title

Hall Technique

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

Modified Hall technique

Intervention Description

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

Primary Outcome Measure Information:

Title

Masseter muscle activity measured by Electromyograph

Description

muscle activity will be measured following the cementation of the crown

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Manal Ahmed El Sayed, Professor

Phone

+201227332259

manal.elsayed@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Passant Nagi Abdelsamea, doctorate

Phone

+201280557107

passant.nagi@dentistry.cu.edu.eg

Facility Information:

Facility Name

Faculty of dentistry Cairo University

City

Cairo

State/Province

EL-Manial

ZIP/Postal Code

11553

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manal Ahmed El sayed, professor

Phone

+201227332259

manal.elsayed@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name & Degree

Passant Nagi Abdelsamea, doctorate

Phone

+201280557107

passant.nagi@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name & Degree

Ahmed Adel Abdelazim, bachelor

12. IPD Sharing Statement

Learn more about this trial

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

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