Pediatric DentistryNCT06592885
Comparing Minimally Invasive Techniques Used In Treatment Of Carious Primary Molars In Children
A study testing Atraumatic Restorative Treatment in treatment of carious primary molars and Hall Technique in treatment of carious primary molars in people with Pediatric Dentistry, run by Cairo University at 1 site in Egypt.
Trial summary
Dental caries is a natural process by which bacteria in the biofilm causes fluctuations in the pH, which leads to enamel erosion and result in visible lesions. If left untreated, caries will progress and result in pain, abscess, and systemic infection, leading to functional and/or psychosocial impairment which is a… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Pediatric Dentistry
- What is being tested?
- Atraumatic Restorative Treatment in treatment of carious primary molars and Hall Technique in treatment of carious primary molars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2024to 1 Nov 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
- No healthy volunteers
- 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.
Mariam Atef Ahmed Dentist, B.D.S., Faculty of Dentistry contact
Egypt1 site
Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.
Cairo
Faculty of Dentistry Cairo University Faculty of Dentistry Cairo University, (+202) 23634965, dentmail@dentistry.cu.edu.eg
About this study
Official title: Evaluation Of Success Of Hall Technique Versus Atraumatic Restorative Treatment In The Management Of Carious Primary Molars: A Randomized Clinical Trial
Dental caries is a natural process by which bacteria in the biofilm causes fluctuations in the pH, which leads to enamel erosion and result in visible lesions. If left untreated, caries will progress and result in pain, abscess, and systemic infection, leading to functional and/or psychosocial impairment which is a serious problem Caries is, in fact, the most prevalent childhood disease in the world and is most prominent among low-economic populations. So, the main goal is to minimize Dental caries as much as possible by applying preventive measures to reduce the occurrence and progression of dental caries.
In that scope, both Atraumatic Restorative Treatment (ART) and the Hall Technique (HT) were created as part of Minimal Invasive Dentistry (MID) to slow the downward restorative spiral and reduce discomfort during the treatment as neither of which requires the administration of local anesthesia nor the use of rotary instruments.
Read more
According to a retrospective analysis, utilizing the Hall technique to seal cavities performed much better than using conventional restorations. statistically and clinically during 10 years of follow-up.
Since ART is associated with lower levels of anxiety, pain, and discomfort than traditional dentistry procedures, it has become widely employed in pediatric dentistry. Despite having reduced survival rates in multiple-surface restorations, ART is still regarded as a viable, evidence-based choice for treating and preventing caries lesions in primary posterior teeth since it is a quick, inexpensive, and comfortable procedure for the patient.
Read the detailed description
One of the most prevalent childhood diseases, dental caries, affects up to 90% of children globally, especially those from the underprivileged group.
WHO estimates that Egypt has a 60% prevalence of dental caries. Early childhood caries has a negative effect on a child's oral health-related quality of life. Both the family and the child are directly affected.
The ideal treatment of carious lesions has been the subject of recent revolutions. Traditional restorative methods, which focused on completely removing carious tooth tissue and then placing a restoration have been replaced by more biological and minimally invasive methods that concentrate on controlling biofilms and disrupting the cariogenic biofilm environment to stop caries.
The Hall Technique (HT) supports this theory. Without any dental preparation or caries removal, a preformed metal crown (PMC) is simply fixed to the carious tooth using glass ionomer cement (GIC). The cariogenic biofilm beneath the cap is sealed.
The Hall technique of stainless- steel crown placement has proved to be a viable restorative option for carious primary molars resulting in its successful exfoliation.
Management techniques would include atraumatic restorative treatment as well as those in which dentine carious tissue is selectively removed to soft or firm dentine in a single session (ART).
ART has been widely used in pediatric dentistry because it is linked with lower levels of anxiety, pain, and discomfort, as well as better acceptance by children, compared to conventional treatment.
ART uses only hand instruments to remove carious tissue and prepare the cavity. Additional extended clinical investigations are required to assess the effectiveness of these methods in addressing carious lesions on diverse tooth surfaces and various dentin layers and to provide evidence supporting the integration of these techniques into standard practice.
Since there is a need for further research, with larger sample sizes and extended follow-up durations in Egypt, to assess the effectiveness of these methods for treating carious primary teeth, this study will be conducted.
This research aims to compare the success of the Hall Technique to the Atraumatic Restorative treatment in the management of carious primary molars in children.
- Conditions
- Pediatric Dentistry
- Being tested
- Atraumatic Restorative Treatment in treatment of carious primary molars, Hall Technique in treatment of carious primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative Treatment in treatment of carious primary molarsProcedure or surgery
ART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration. This technique aims to be minimally invasive, promoting the preservation of tooth structure. The ART technique, employed in situations where ideal clinical conditions are challenging to achieve, has demonstrated effectiveness as a reliable method for managing cases where conventional treatment methods face resistance from children . However, concerns exist regarding the longevity of ART restorations and the impact of operator skill on outcomes.
Hall Technique in treatment of carious primary molarsProcedure or surgery
The Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia.
Advocates of the Hall technique emphasize its simplicity, reduced need for traditional drilling, and high reported success rates in clinical studies.
However, concerns have been raised regarding long-term aesthetics and potential psychological impacts due to the visibility of metal crowns.
| Study group | Role | What they receive |
|---|---|---|
| Hall Technique in treatment of carious primary molars | Active comparator | The Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia Receives: Procedure: Hall Technique in treatment of carious primary molars |
| Atraumatic Restorative Treatment in treatment of carious primary molars | Experimental | ART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration, promoting the preservation of tooth structure. Receives: Procedure: Atraumatic Restorative Treatment in treatment of carious primary molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success, Assessed by clinical examination
- Standard clinical criteria will be used to determine whether a restoration (ART/HT) was successful or not in terms of having a satisfactory restoration that requires no further intervention and also the absence of any signs or symptoms of pulp damage.
- Measuring unit is Binary (Yes/No)
Measured: From enrollment to the end of treatment at 12 months (with follow up at 3-6-9-12 months)
Secondary outcomes (4)
Post-operative 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), which has six numbered faces from 0 to10. Each child will be asked to mark the face that reflects her or his experienced pain during the treatment. There is no pain visible on the first face [indicating the face on the far left]. As you move from left to right, the faces get progressively more painful until you reach the last, which is incredibly painful [indicating the face on the far right]. The (FPS-R) faces will be scored as 0-2-4-6-8-10.
Measured: Measured immediately after placement of SSC or restoration
Child Behavior
Venham Anxiety Rating Scale is a reliable system for rating behavior of children in the dental setting, a child\'s fear and lack of cooperation are assessed using five behaviorally defined categories, ranging from zero to five (Six-point scales 0-1- 2-3-4-5), which are included in each measure; higher values denote greater anxiety or an uncooperative manner.
Measured: Measured immediately after placement of SSC or restoration
Child Anxiety
Venham behavior rating scale is a reliable system for rating the behavior of children in the dental setting.a child\'s fear and lack of cooperation are assessed using five behaviorally defined categories, ranging from zero to five (Six-point scales 0-1- 2-3-4-5), which are included in each measure; higher values denote greater anxiety or an uncooperative manner.
Measured: Measured immediately after placement of SSC or restoration
Canine overbite: HT
- The canine overbite will be calculated in millimeters 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's Gauge.
- If checking the same side was not possible (e.g., loss of canine) the distance between canines on the other side will be measured.
- These prefabricated SSCs will be pre-trimmed to the optimum length, belled, and pre-crimped at the cervical margin.
- The SSC will be loaded with glass ionomer luting cement and partially fitted on the tooth using a finger. The patient will be asked to bite on a cotton roll and the SSC will be fully seated.
- Excess cement will be removed; Post-treatment overbite (immediately after the treatment) will be recorded.
- Changes in the canine overbite will be determined by subtracting the follow-up canine overbite from the baseline (pretreatment).
Measured: Measured in millimeters immediately after placement of pre-fabricated stainless steel crown (SSC)
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 startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric DentistryStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Atef Ahmed, Cairo University
- Investigators
- Gihan Abou Elneil Professor of Pediatric Dentistry and Dental Public Health, Professor, Study director, Cairo UniversityAhmed El. Khadem Associate Professor of Pediatric Dentistry, Associate Professor, Study director, Cairo UniversityDr. Shereen Hassan El-Shamy Lecturer of Pediatric Dentistry, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592885
- Sponsor's protocol ID
- HT Vs ART in pedodontics
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kaptan A, Korkmaz E. Evaluation of success of stainless steel crowns placed using the hall technique in children with high caries risk: A randomized clinical trial. Niger J Clin Pract. 2021 Mar;24(3):425-434. doi: 10.4103/njcp.njcp_112_20.
PubMed 33723119
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 Success Of Hall Technique Versus Atraumatic Restorative Treatment In The Management Of Carious Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06592885
- Acronym / sponsor ID
- HT Vs ART in pedodontics
- Conditions
- Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- 1 Nov 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.
Dental caries is a natural process by which bacteria in the biofilm causes fluctuations in the pH, which leads to enamel erosion and result in visible lesions. If left untreated, caries will progress and result in pain, abscess, and systemic infection, leading to functional and/or psychosocial impairment which is a serious problem Caries is, in fact, the most prevalent childhood disease in the world and is most prominent among low-economic populations. So, the main goal is to minimize Dental caries as much as possible by applying preventive measures to reduce the occurrence and progression of dental caries.
In that scope, both Atraumatic Restorative Treatment (ART) and the Hall Technique (HT) were created as part of Minimal Invasive Dentistry (MID) to slow the downward restorative spiral and reduce discomfort during the treatment as neither of which requires the administration of local anesthesia nor the use of rotary instruments.
According to a retrospective analysis, utilizing the Hall technique to seal cavities performed much better than using conventional restorations. statistically and clinically during 10 years of follow-up.
Since ART is associated with lower levels of anxiety, pain, and discomfort than traditional dentistry procedures, it has become widely employed in pediatric dentistry. Despite having reduced survival rates in multiple-surface restorations, ART is still regarded as a viable, evidence-based choice for treating and preventing caries lesions in primary posterior teeth since it is a quick, inexpensive, and comfortable procedure for the patient.
Detailed description
One of the most prevalent childhood diseases, dental caries, affects up to 90% of children globally, especially those from the underprivileged group.
WHO estimates that Egypt has a 60% prevalence of dental caries. Early childhood caries has a negative effect on a child's oral health-related quality of life. Both the family and the child are directly affected.
The ideal treatment of carious lesions has been the subject of recent revolutions. Traditional restorative methods, which focused on completely removing carious tooth tissue and then placing a restoration have been replaced by more biological and minimally invasive methods that concentrate on controlling biofilms and disrupting the cariogenic biofilm environment to stop caries.
The Hall Technique (HT) supports this theory. Without any dental preparation or caries removal, a preformed metal crown (PMC) is simply fixed to the carious tooth using glass ionomer cement (GIC). The cariogenic biofilm beneath the cap is sealed.
The Hall technique of stainless- steel crown placement has proved to be a viable restorative option for carious primary molars resulting in its successful exfoliation.
Management techniques would include atraumatic restorative treatment as well as those in which dentine carious tissue is selectively removed to soft or firm dentine in a single session (ART).
ART has been widely used in pediatric dentistry because it is linked with lower levels of anxiety, pain, and discomfort, as well as better acceptance by children, compared to conventional treatment.
ART uses only hand instruments to remove carious tissue and prepare the cavity. Additional extended clinical investigations are required to assess the effectiveness of these methods in addressing carious lesions on diverse tooth surfaces and various dentin layers and to provide evidence supporting the integration of these techniques into standard practice.
Since there is a need for further research, with larger sample sizes and extended follow-up durations in Egypt, to assess the effectiveness of these methods for treating carious primary teeth, this study will be conducted.
This research aims to compare the success of the Hall Technique to the Atraumatic Restorative treatment in the management of carious primary molars in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hall Technique in treatment of carious primary molars | Active comparator | Procedure: Hall Technique in treatment of carious primary molarsThe Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia |
| Atraumatic Restorative Treatment in treatment of carious primary molars | Experimental | Procedure: Atraumatic Restorative Treatment in treatment of carious primary molarsART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration, promoting the preservation of tooth structure. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Atraumatic Restorative Treatment in treatment of carious primary molarsART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration. This technique aims to be minimally invasive, promoting the preservation of tooth structure. The ART technique, employed in situations where ideal clinical conditions are challenging to achieve, has demonstrated effectiveness as a reliable method for managing cases where conventional treatment methods face resistance from children . However, concerns exist regarding the longevity of ART restorations and the impact of operator skill on outcomes. | Procedure or surgery | Atraumatic Restorative Treatment in treatment of carious primary molars |
| Hall Technique in treatment of carious primary molarsThe Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia. Advocates of the Hall technique emphasize its simplicity, reduced need for traditional drilling, and high reported success rates in clinical studies. However, concerns have been raised regarding long-term aesthetics and potential psychological impacts due to the visibility of metal crowns. | Procedure or surgery | Hall Technique in treatment of carious primary molars |
Primary outcome
Clinical Success, Assessed by clinical examination
Time frame: From enrollment to the end of treatment at 12 months (with follow up at 3-6-9-12 months)
* Standard clinical criteria will be used to determine whether a restoration (ART/HT) was successful or not in terms of having a satisfactory restoration that requires no further intervention and also the absence of any signs or symptoms of pulp damage. * Measuring unit is Binary (Yes/No)
4 secondary outcomes
Post-operative pain and discomfort
Time frame: Measured immediately after placement of SSC or restoration
Child Behavior
Time frame: Measured immediately after placement of SSC or restoration
Child Anxiety
Time frame: Measured immediately after placement of SSC or restoration
Canine overbite: HT
Time frame: Measured in millimeters immediately after placement of pre-fabricated stainless steel crown (SSC)
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.
- Results publication: PubMed 33723119Kaptan A, Korkmaz E. Evaluation of success of stainless steel crowns placed using the hall technique in children with high caries risk: A randomized clinical trial. Niger J Clin Pract. 2021 Mar;24(3):425-434. doi: 10.4103/njcp.njcp_112_20.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mariam Atef Ahmed Dentist, B.D.S., Faculty of Dentistry contact
Gihan Abou Elneil Professor of Pediatric Dentistry and Dental Public Health, Professor study director
Cairo University
Ahmed El. Khadem Associate Professor of Pediatric Dentistry, Associate Professor study director
Cairo University
Dr. Shereen Hassan El-Shamy Lecturer of Pediatric Dentistry study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment in treatment of carious primary molars and Hall Technique in treatment of carious primary molars in people with Pediatric Dentistry, 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?
Contact Mariam Atef Ahmed Dentist, B.D.S., Faculty of Dentistry (1111199543 ext. +20, mariam.wahid@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success, Assessed by clinical examination (time frame: From enrollment to the end of treatment at 12 months (with follow up at 3-6-9-12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06592885, which also lists 1 linked publication.
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.