Caries,DentalNCT06597669
Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars
A study testing Placement of stainless steel crowns on primary molars in people with Caries,Dental, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Placement of stainless steel crowns on primary molars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Sep 2024to May 2026
- 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
- Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.
Who cannot join
- Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
- Children are allergic to nickel and resin.
- Children unable to return for recall visits.
- Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
- Children are undergoing orthodontic treatment with fixed or removable appliances.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Hue University of Medicine and Pharmacy
Huế, Thừa Thiên Huế Province, 49120
Thanh Thao Nguyen, MD, PhD, +84234 3822 173, stir@huemed-univ.edu.vn
Van Nhat Thang Le, DDS, PhD
About this study
Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars
- Conditions
- Caries,Dental
- Being tested
- Placement of stainless steel crowns on primary molars
- Keywords
- Dental caries, Primary molars, Stainless steel crowns
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of stainless steel crowns on primary molarsProcedure or surgery
Preformed metal crowns have been placed to treat caries in primary molars
| Study group | Role | What they receive |
|---|---|---|
| Conventional Technique | Experimental | A stainless steel crown will place on a carious primary molar after preparation Receives: Procedure: Placement of stainless steel crowns on primary molars |
| Hall technique | Experimental | A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation Receives: Procedure: Placement of stainless steel crowns on primary molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of stainless steel crowns
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Measured: 3 months
Failure of stainless steel crowns
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Measured: 6 months
Failure of stainless steel crowns
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Measured: 9 months
Failure of stainless steel crowns
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Measured: 12 months
Secondary outcomes (10)
Occlusal contact
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
Measured: 0 months
Occlusal contact
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
Measured: 3 months
Occlusal contact
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
Measured: 6 months
Occlusal contact
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
Measured: 9 months
Occlusal contact
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
Measured: 12 months
Periodontal health
- Plaque index 0 = No plaque in the gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
- Gingival index 0 = Normal gingiva
- = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
- = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
- = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Measured: 0 months
Periodontal health
- Plaque index 0 = No plaque in the gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
- Gingival index 0 = Normal gingiva
- = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
- = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
- = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Measured: 3 months
Periodontal health
- Plaque index 0 = No plaque in the gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
- Gingival index 0 = Normal gingiva
- = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
- = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
- = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Measured: 6 months
Periodontal health
- Plaque index 0 = No plaque in the gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
- Gingival index 0 = Normal gingiva
- = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
- = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
- = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Measured: 9 months
Periodontal health
- Plaque index 0 = No plaque in the gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
- Gingival index 0 = Normal gingiva
- = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
- = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
- = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Measured: 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 start4 Sep 2024
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Van Nhat Thang, Hue University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597669
- Sponsor's protocol ID
- H2024/097
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will plan to share information when finishing study
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
- Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars
- ClinicalTrials.gov ID
- NCT06597669
- Acronym / sponsor ID
- H2024/097
- Conditions
- Caries,Dental
- Keywords
- Dental caries, Primary molars, Stainless steel crowns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (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.
Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Technique | Experimental | Procedure: Placement of stainless steel crowns on primary molarsA stainless steel crown will place on a carious primary molar after preparation |
| Hall technique | Experimental | Procedure: Placement of stainless steel crowns on primary molarsA stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
- Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.
Key exclusion criteria (5 listed)
- Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
- Children are allergic to nickel and resin.
- Children unable to return for recall visits.
- Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
- Children are undergoing orthodontic treatment with fixed or removable appliances.
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 |
|---|---|---|
| Placement of stainless steel crowns on primary molarsPreformed metal crowns have been placed to treat caries in primary molars | Procedure or surgery | Conventional Technique, Hall technique |
Primary outcome
Failure of stainless steel crowns
Time frame: 3 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Failure of stainless steel crowns
Time frame: 6 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Failure of stainless steel crowns
Time frame: 9 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
Failure of stainless steel crowns
Time frame: 12 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
10 secondary outcomes
Occlusal contact
Time frame: 0 months
Occlusal contact
Time frame: 3 months
Occlusal contact
Time frame: 6 months
Occlusal contact
Time frame: 9 months
Occlusal contact
Time frame: 12 months
Periodontal health
Time frame: 0 months
Periodontal health
Time frame: 3 months
Periodontal health
Time frame: 6 months
Periodontal health
Time frame: 9 months
Periodontal health
Time frame: 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. Will plan to share information when finishing study
Related trials for Caries,Dental
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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 Placement of stainless steel crowns on primary molars in people with Caries,Dental, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
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 2 inclusion and 5 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 Vietnam. 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?
Failure of stainless steel crowns (time frame: 3 months). The study lists 4 primary outcomes in all. 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.