Masseter Muscle ActivityNCT05409742
Masseter Muscle Activity and Post-operative Pain in a Group of Egyptian Children Treated With Hall Technique Vs Modified Hall Technique
A study testing Modified Hall technique in people with Masseter Muscle Activity, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Masseter Muscle Activity
- What is being tested?
- Modified Hall technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 5-7 years with carious lower second primary molars
- Both genders.
- Systemically and mentally healthy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry Cairo University
Cairo, EL-Manial, 11553
Manal Ahmed El sayed, professor, +201227332259, manal.elsayed@dentistry.cu.edu.eg
Passant Nagi Abdelsamea, doctorate, +201280557107, passant.nagi@dentistry.cu.edu.eg
About this study
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
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).
- Conditions
- Masseter Muscle Activity
- Being tested
- Modified Hall technique
- Keywords
- Hall technique, Modified Hall technique, Stainless steel crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Hall techniqueDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Modified Hall technique | Active comparator | Not described Receives: Diagnostic Test: Modified Hall technique |
| Hall Technique | Experimental | Not described Receives: Diagnostic Test: Modified Hall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseter muscle activity measured by Electromyograph
muscle activity will be measured following the cementation of the crown
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masseter Muscle ActivityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Abdelazim Abdelsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409742
- Sponsor's protocol ID
- PEDO 4-8-3
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05409742
- Acronym / sponsor ID
- PEDO 4-8-3
- Conditions
- Masseter Muscle Activity
- Keywords
- Hall technique, Modified Hall technique, Stainless steel crowns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Hall technique | Active comparator | Diagnostic Test: Modified Hall technique |
| Hall Technique | Experimental | Diagnostic Test: Modified Hall technique |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 5-7 years with carious lower second primary molars
- Both genders.
- Systemically and mentally healthy.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Hall techniqueThe 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 | Diagnostic test | Hall Technique, Modified Hall technique |
Primary outcome
Masseter muscle activity measured by Electromyograph
Time frame: 6 weeks
muscle activity will be measured following the cementation of the crown
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Hall technique in people with Masseter Muscle Activity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Ahmed El Sayed, Professor (+201227332259, manal.elsayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter muscle activity measured by Electromyograph (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.