Decayed Primary MolarsNCT06591143
Evaluation Of Periodontal Health After Treatment With Hall Technique Versus Atraumatic Restorative Treatment in The Management of Carious Primary Molars
A study testing ART and Hall technique in people with Decayed Primary Molars, run by Cairo University at 1 site in Egypt.
Trial summary
This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \& ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Primary Molars
- What is being tested?
- ART and Hall technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Dec 2025
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: From 4 to 6 years.
- Caries in primary molars within enamel/dentin with vital pulp.
- Healthy children.
- Cooperative children.
Who cannot join
- Presence of signs and symptoms of necrosis.
- Root caries.
- History of Spontaneous pain.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university
Cairo
cairo university Faculty of dentistry, 00201002159535, Dentmail@dentistry.cu.edu.eg
About this study
Official title: Evaluation Of Periodontal Health After Treatment With Hall Technique Compared to Atraumatic Restorative Treatment in The Management of Carious Primary Molars: A Randomized Clinical Trial
This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \& ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to achieve better treatment for caries with pain-free procedures in developing countries that have high caries index and low income.
- Conditions
- Decayed Primary Molars
- Being tested
- ART, Hall technique
- Keywords
- Decayed primary molars ART Hall technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTProcedure or surgery
Caries excavation with hand instruments only and restoration with glass ionomer filling
Hall techniqueProcedure or surgery
Stainless steel crown placement without tooth preparation
| Study group | Role | What they receive |
|---|---|---|
| ART | Experimental | Atraumatic restorative treatment Receives: Procedure: ART |
| Hall technique | Experimental | Stainless steel crown placement without tooth preparation Receives: Procedure: Hall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal health
While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) using plaque index (0: no plaque, 2: thick visible plaque easily detected)
Measured: initial, 3 months, 6 months, 12 months
Secondary outcomes (5)
Gingival index
While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) (0= no swelling, 2= Moderate to severe gingival swelling, bleeding after air drying)
Measured: Initial, 3 months, 6 months, 12 months
Postoperative pain and discomfort
Immediately after the treatment, any pain and discomfort experienced by the child will be recorded using the Face Pain Scale - revised (FPS-R) (0= no pain, 10=worst)
Measured: Immediately postoperative
Child behaviour
Venham Anxiety Rating Scale (0= total cooperation, best possible working conditions, no crying or physical protest, 5= general protest, no cooperation, physical restraint is required)
Measured: Intraoperative
Child anxiety
Venham Anxiety Rating Scale (0= relaxed, smiling, willing, and able to converse, 5= loud crying unable to listen to verbal communication)
Measured: Intraoperative
Canine overbite
The canine overbite will be calculated before the preparation by measuring the distance between the incisal points of the maxillary canine on the same side of the mouth to the gingival zenith of the mandibular canine using a Boley Gauge
Measured: Initial, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decayed Primary MolarsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Medhat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591143
- Sponsor's protocol ID
- HT Vs ART
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Periodontal Health After Treatment With Hall Technique Compared to Atraumatic Restorative Treatment in The Management of Carious Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06591143
- Acronym / sponsor ID
- HT Vs ART
- Conditions
- Decayed Primary Molars
- Keywords
- Decayed primary molars ART Hall technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \& ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to achieve better treatment for caries with pain-free procedures in developing countries that have high caries index and low income.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART | Experimental | Procedure: ARTAtraumatic restorative treatment |
| Hall technique | Experimental | Procedure: Hall techniqueStainless steel crown placement without tooth preparation |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: From 4 to 6 years.
- Caries in primary molars within enamel/dentin with vital pulp.
- Healthy children.
- Cooperative children.
Key exclusion criteria (3 listed)
- Presence of signs and symptoms of necrosis.
- Root caries.
- History of Spontaneous pain.
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 |
|---|---|---|
| ARTCaries excavation with hand instruments only and restoration with glass ionomer filling | Procedure or surgery | ART |
| Hall techniqueStainless steel crown placement without tooth preparation | Procedure or surgery | Hall technique |
Primary outcome
Periodontal health
Time frame: initial, 3 months, 6 months, 12 months
While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) using plaque index (0: no plaque, 2: thick visible plaque easily detected)
5 secondary outcomes
Gingival index
Time frame: Initial, 3 months, 6 months, 12 months
Postoperative pain and discomfort
Time frame: Immediately postoperative
Child behaviour
Time frame: Intraoperative
Child anxiety
Time frame: Intraoperative
Canine overbite
Time frame: Initial, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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Clinical and Radiographic Evaluation of Injectable Composite Versus Packable Composite in Restoring of Primary Molars
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Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars
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Pulpitis - Reversible, Occlusal Caries
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 ART and Hall technique in people with Decayed Primary Molars, 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 4 inclusion and 3 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 19 Sep 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal health (time frame: initial, 3 months, 6 months, 12 months). 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 19 Sep 2024.