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RecruitingNCT06597669Updated Sep 19, 2024

Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars

An interventional study of Placement of stainless steel crowns on primary molars in Caries,Dental, sponsored by Hue University of Medicine and Pharmacy. Recruiting at 1 site in Vietnam. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Hue University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
3 Years to 9 Years
Sex
All
01

Study 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

02

Conditions studied

  • Caries,Dental

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Keywords

  • Dental caries
  • Primary molars
  • Stainless steel crowns
03

In context

Dental Caries

1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 967 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Hue University of Medicine and Pharmacy is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
  2. 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.

Exclusion criteria

Exclusion Criteria:

  1. Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
  2. Children are allergic to nickel and resin.
  3. Children unable to return for recall visits.
  4. Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
  5. Children are undergoing orthodontic treatment with fixed or removable appliances.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Conventional Technique

    A stainless steel crown will place on a carious primary molar after preparation

    Procedure: Placement of stainless steel crowns on primary molars

  • Experimental
    Hall technique

    A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation

    Procedure: Placement of stainless steel crowns on primary molars

Interventions

  • ProcedurePlacement of stainless steel crowns on primary molars

    Preformed metal crowns have been placed to treat caries in primary molars

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 9 months

  4. 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.

    Time frame: 12 months

Secondary outcomes

  1. Occlusal contact

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

    Time frame: 0 months

  2. Occlusal contact

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

    Time frame: 3 months

  3. Occlusal contact

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

    Time frame: 6 months

  4. Occlusal contact

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

    Time frame: 9 months

  5. Occlusal contact

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

    Time frame: 12 months

  6. Periodontal health

    * Plaque index 0 = No plaque in the gingival area. 1. = 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. 2. = 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. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. * Gingival index 0 = Normal gingiva 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.

    Time frame: 0 months

  7. Periodontal health

    * Plaque index 0 = No plaque in the gingival area. 1. = 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. 2. = 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. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. * Gingival index 0 = Normal gingiva 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.

    Time frame: 3 months

  8. Periodontal health

    * Plaque index 0 = No plaque in the gingival area. 1. = 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. 2. = 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. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. * Gingival index 0 = Normal gingiva 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.

    Time frame: 6 months

  9. Periodontal health

    * Plaque index 0 = No plaque in the gingival area. 1. = 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. 2. = 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. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. * Gingival index 0 = Normal gingiva 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.

    Time frame: 9 months

  10. Periodontal health

    * Plaque index 0 = No plaque in the gingival area. 1. = 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. 2. = 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. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. * Gingival index 0 = Normal gingiva 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Will plan to share information when finishing study

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Mar 2026, 18 months after the start.

Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 18 months is above that.

Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2024
First posted
Sep 19, 2024
StartActual
Sep 4, 2024
Primary completionEst.
Mar 2026
CompletionEst.
May 2026
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06597669
Lead sponsor
Hue University of Medicine and Pharmacy
Responsible party
Le Van Nhat Thang (Lecturer, Hue University of Medicine and Pharmacy) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 4, 2024
Primary completion
Mar 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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