Dental CariesNCT04818658
The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration
An observational study of Dental Caries and Caries; Dentin, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Caries; Dentin
- What is being tested?
- Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars
- Type of treatment
- Pill or oral medicine
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2021to 10 Dec 2021
- Phase
- Observational
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: patients aged 5-8 years treated with preformed metal crowns using Hall Technique and compomer restoration
Who may be able to join
- patients aged five to eight years at the time of dental treatment,
- patients attending follow-up appointments
- patients with compomer restoration and Hall restoration in their teeth
- patients with matching the extent of caries in the two groups
Who cannot join
- patients not attending follow-up appointments
- patients without both treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration: A 5-year Retro-prospective Clinical Study
The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.
Read the detailed description
comparing the survival rate of the conventional restorations with the Hall Technique in carious primary molars.
- Conditions
- Dental Caries, Caries; Dentin
- Being tested
- Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molarsOther
Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Preformed Metal Crowns using Hall Technique | Not described Receives: Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars | |
| Compomer Restoration | Not described Receives: Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival rate of Hall Technique and Compomer Restorations
- Successful: restoration satisfactory, no additional treatment required, no clinical sign and symptoms of pulpal pathology or tooth exfoliated,
- Minor failure: restoration wear/fracture/loss (restorable) or crown perforation, secondary caries or new caries, reversible pulpitis treated without requiring extraction or pulpotomy,
- Major failure: the tooth is broken down (unrestorable), inter-radicular radiolucency or internal root resorption, signs or symptoms of irreversible pulpitis requiring extraction or pulpotomy.
- The survival analysis: the restorations are assessed as successful or failure.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start8 Mar 2021
- Primary completion3 Oct 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Sen Yavuz, Bahçeşehir University
- Investigators
- Betul Sen Yavuz, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818658
- Sponsor's protocol ID
- 441555555
- Status last verified
- Jul 2022
- First submitted
- 24 Mar 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration: A 5-year Retro-prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04818658
- Acronym / sponsor ID
- 441555555
- Conditions
- Dental Caries, Caries; Dentin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 26 Mar 2021 (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 aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.
Detailed description
comparing the survival rate of the conventional restorations with the Hall Technique in carious primary molars.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preformed Metal Crowns using Hall Technique | – | Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars |
| Compomer Restoration | – | Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- patients aged 5-8 years treated with preformed metal crowns using Hall Technique and compomer restoration
Key inclusion criteria (4 listed)
- patients aged five to eight years at the time of dental treatment,
- patients attending follow-up appointments
- patients with compomer restoration and Hall restoration in their teeth
- patients with matching the extent of caries in the two groups
Key exclusion criteria (2 listed)
- patients not attending follow-up appointments
- patients without both treatment
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 |
|---|---|---|
| Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molarsIntra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines. | Other | Compomer Restoration, Preformed Metal Crowns using Hall Technique |
Primary outcome
The survival rate of Hall Technique and Compomer Restorations
Time frame: 5 year
1. Successful: restoration satisfactory, no additional treatment required, no clinical sign and symptoms of pulpal pathology or tooth exfoliated, 2. Minor failure: restoration wear/fracture/loss (restorable) or crown perforation, secondary caries or new caries, reversible pulpitis treated without requiring extraction or pulpotomy, 3. Major failure: the tooth is broken down (unrestorable), inter-radicular radiolucency or internal root resorption, signs or symptoms of irreversible pulpitis requiring extraction or pulpotomy. 4. The survival analysis: the restorations are assessed as successful or failure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Betul Sen Yavuz principal investigator
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Caries; Dentin, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 21 Jul 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survival rate of Hall Technique and Compomer Restorations (time frame: 5 year). 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 21 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.