Primary TeethNCT03433157
Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique
A study testing Hall technique and Traditional technique in people with Primary Teeth and Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Teeth, Dental Caries, Dentin, Carious
- What is being tested?
- Hall technique and Traditional technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to Dec 2024
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and parents of the patients who accept to participate and sign the informed consent
- Patients who have two first and/or second primary molars with caries affecting at least two surfaces
- Patients who are cooperative for the dental procedure
Who cannot join
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Teeth that are previously restored
- Patients with a systemic disease,
- Patients who have orthodontic treatment
- Teeth which have a short period of time for succedaneous teeth to erupt
- Teeth which need vital or non-vital endodontic treatment
- Patients and/or parents who does not accept the esthetic appearance of SSC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiological Evaluation of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique
Read the detailed description
Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.
Group 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.
- Conditions
- Primary Teeth, Dental Caries, Dentin, Carious
- Being tested
- Hall technique, Traditional technique
- Keywords
- stainless stain crowns, Hall technique, children
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall techniqueDevice
Metal Stainless stain crown placed with Hall technique
Traditional techniqueDevice
Metal Stainless stain crown placed with Traditional technique
| Study group | Role | What they receive |
|---|---|---|
| Hall technique | Experimental | SSCs placed on primary teeth using Hall technique Receives: Device: Hall technique |
| Traditional technique | Active comparator | SSCs placed on primary teeth using Traditional technique Receives: Device: Traditional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
Assessment of SSCs placed with two different techniques on primary molar teeth. The cooperation of children will be assessed with Frankl Scale (1:definitely negative, 2:negative, 3:positive, 4:definitely positive).
Evaluation criteria will be;
- spontaneous pain (absent/present);
- tenderness to percussion/palpation (absent/present);
- mobility (no mobility/ 1mm/ 2mm/ 3mm mobility)
- swelling (absent/present);
- fistula (absent/present)
- periapical/interradicular radiolucency (absent/present);
- widened periodontal ligament (absent/present);
- loss of lamina dura (absent/present);
- internal/external root resorption (absent/present)
- the marginal adaptation of each crown: good when the margins were sealed / poor when the margins were open
- retention of the crown (absent/ present)
- fracture of the crown (absent/ present)
- gingival health/gingivitis (absent/ present)
- plaque around the crown (absent/ present)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Aug 2019
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (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 Primary TeethStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
- Investigators
- Zafer C Cehreli, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433157
- Sponsor's protocol ID
- Hall vs SSC
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2018
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. No abstract available.
PubMed 25987388
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
- ClinicalTrials.gov ID
- NCT03433157
- Acronym / sponsor ID
- Hall vs SSC
- Conditions
- Primary Teeth, Dental Caries, Dentin, Carious
- Keywords
- stainless stain crowns, Hall technique, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Feb 2018 (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 purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique
Detailed description
Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.
Group 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hall technique | Experimental | Device: Hall techniqueSSCs placed on primary teeth using Hall technique |
| Traditional technique | Active comparator | Device: Traditional techniqueSSCs placed on primary teeth using Traditional technique |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients and parents of the patients who accept to participate and sign the informed consent
- Patients who have two first and/or second primary molars with caries affecting at least two surfaces
- Patients who are cooperative for the dental procedure
Key exclusion criteria (7 listed)
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Teeth that are previously restored
- Patients with a systemic disease,
- Patients who have orthodontic treatment
- Teeth which have a short period of time for succedaneous teeth to erupt
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 |
|---|---|---|
| Hall techniqueMetal Stainless stain crown placed with Hall technique | Device | Hall technique |
| Traditional techniqueMetal Stainless stain crown placed with Traditional technique | Device | Traditional technique |
Primary outcome
Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
Time frame: 2 years
Assessment of SSCs placed with two different techniques on primary molar teeth. The cooperation of children will be assessed with Frankl Scale (1:definitely negative, 2:negative, 3:positive, 4:definitely positive). Evaluation criteria will be; * spontaneous pain (absent/present); * tenderness to percussion/palpation (absent/present); * mobility (no mobility/ 1mm/ 2mm/ 3mm mobility) * swelling (absent/present); * fistula (absent/present) * periapical/interradicular radiolucency (absent/present); * widened periodontal ligament (absent/present); * loss of lamina dura (absent/present); * internal/external root resorption (absent/present) * the marginal adaptation of each crown: good when the margins were sealed / poor when the margins were open * retention of the crown (absent/ present) * fracture of the crown (absent/ present) * gingival health/gingivitis (absent/ present) * plaque around the crown (absent/ present)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 25987388Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. No abstract available.
- Individual participant dataSharing planned: No
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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.
Zafer C Cehreli principal investigator
Hacettepe 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 Hall technique and Traditional technique in people with Primary Teeth and Dental Caries, run by Hacettepe 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 3 inclusion and 7 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 15 Mar 2021. 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?
Results are not available in the source record.
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?
Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique (time frame: 2 years). 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 NCT03433157, 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 15 Mar 2021.