Child, OnlyNCT06220383
Evaluation of The Effect of Crowns Applied With Hall Technique on Occlusion
A study testing Hall technique and Conventional technique in people with Child, Only and Quality of Life, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate and compare the change on occlusion after placing stainless steel crowns (SCC) using Hall technique and conventional technique in children between the ages of 5-8. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Quality of Life
- What is being tested?
- Hall technique and Conventional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2022to 20 Dec 2023
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects with American Society of Anesthesiologists score I (ASA I),
- Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
- Clinically, Black class II enamel-dentin caries in the upper jaw primary second molar is; ICDAS II Scale score 4, score 5 and the accepted values in the evaluation of radiographic dental caries are D1-RA3, D2-RB4, D3-RC5,
- Antagonist of the tooth planned to be processed,
- Lamina dura and periodontal space can be observed normally
- There is permanent tooth germ underneath or the position is normal.
Who cannot join
- Allergic to the local anesthetics or sulfites,
- Had teeth with pain or sepsis,
- Were uncooperative during clinical examination,
- TMJ disorder,
- Had parafunctional habit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of The Effect of Crowns Applied wıth Hall Technique on Occlusion: Randomized Clinical Study
This study aims to evaluate and compare the change on occlusion after placing stainless steel crowns (SCC) using Hall technique and conventional technique in children between the ages of 5-8. In addition, the investigators planned to analyze the change in oral health-related quality of life between SCC applied with the Hall technique and SCC applied with the conventional method, before and after clinical application.
Read the detailed description
First, the participants who met the inclusion criteria were included in 2 study groups according to age, gender, dental experience, tooth number, applied stainless steel crown technique, Decayed, Missing due to caries, and Filled teeth in the permanent teeth/decayed, missing due to caries, and filled teeth in the deciduous teeth (DMFT/dmft index) values and International Caries Detection and Assessment System (ICDAS II) and radiographic evaluation criteria. In the experimental group, stainless steel crowns were placed on the teeth of 39 participants using the Hall technique. In the control group, stainless steel crowns were placed on the teeth of 39 participants using conventional technique.
- Conditions
- Child, Only, Quality of Life
- Being tested
- Hall technique, Conventional technique
- Keywords
- Hall technique, Paediatric dentistry, Stainless Steel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall techniqueProcedure or surgery
Prepless crown technique
Conventional techniqueProcedure or surgery
1 or 1,5 mm preparation on mesial, distal and occlusal of the tooth
| Study group | Role | What they receive |
|---|---|---|
| Hall technique | Experimental | In the Hall technique method, an orthodontic separator was placed 2 days before the procedure to create distance for the crown in the mesial and distal contact areas of the tooth on which the crown will be placed. A stainless steel crown was cemented on the tooth with glass ionomer cement without local anesthesia, caries cleaning or any preparation. The participant was asked to close the teeth tightly for 2-3 minutes. Receives: Procedure: Hall technique |
| Conventional technique | Active comparator | In the conventional technique, after the area to be anesthetized was dried, topical anesthetic solution (Locanest 10% spray lidocaine, Avixa, Turkey) was applied to the mucosa with a cotton pellet for one minute. For infiltrative anesthesia, 4% articaine solution (Ultracaine DS Forte ampoule, Sanofi-Aventis GmbH, Germany) containing 1 ml of 1:100,000 epinephrine was applied. Preparation was made on the mesial, distal and occlusal sides of the tooth. The decay was cleaned and the cavity was filled with glass ionomer cement (Ketac Molar Easymix, 3M™ ESPE™, St. Paul, MN, USA). The stainless steel crown was bonded with glass ionomer cement (Ketac Cem Easymix, 3M™ ESPE™, St. Paul, MN, USA). Receives: Procedure: Conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of intrusion of teeth with stainless steel crown applied with Hall technique using Gom Inspect
Intrusion scores in Hall technique 0-3, where 0 means no movement, 3 means intrusion
Measured: Immediately before the procedure and one month control
The measurement of intrusion of teeth with stainless steel crown applied with conventional technique using Gom Inspect
0-3, where 0 means no movement, 3 means extrusion
Measured: Immediately before the procedure and one month control
Change from measurement the distance between the cusps of canines with stainless steel crown applied with Hall technique using Exocad
0-2, where 0 means no movement, 2 means no closure
Measured: Immediately before the procedure and one month control
Change from measurement the distance between the cusps of canines with stainless steel crown applied with conventional technique using Exocad
0-2, where 0 means no movement, 2 means no closure
Measured: Immediately before the procedure and one month control
Secondary outcomes (2)
Measuring the impact of stainless steel crowns on oral health and quality of life in children section with the Early Childhood Oral Health Impact Scale
Child sections have a possible range from 0 to 36. 0=Never or hardly ever 36= Occasionally, often, or very often
Measured: Immediately after the procedure and one month control
Measuring the impact of stainless steel crowns on oral health and quality of life in parents section with the Early Childhood Oral Health Impact Scale
Family sections have a possible range from 0 to 16. 0=Never or hardly ever 16= Occasionally, often, or very often
Measured: Immediately after the procedure and one month control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start5 Oct 2022
- Primary completion12 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- Model description
- Randomized controlled, double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Cagırır Dindaroglu, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220383
- Sponsor's protocol ID
- 2022-TDU-DİŞF-0013
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Crowns Applied wıth Hall Technique on Occlusion: Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06220383
- Acronym / sponsor ID
- 2022-TDU-DİŞF-0013
- Conditions
- Child, Only, Quality of Life
- Keywords
- Hall technique, Paediatric dentistry, Stainless Steel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 23 Jan 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.
This study aims to evaluate and compare the change on occlusion after placing stainless steel crowns (SCC) using Hall technique and conventional technique in children between the ages of 5-8. In addition, the investigators planned to analyze the change in oral health-related quality of life between SCC applied with the Hall technique and SCC applied with the conventional method, before and after clinical application.
Detailed description
First, the participants who met the inclusion criteria were included in 2 study groups according to age, gender, dental experience, tooth number, applied stainless steel crown technique, Decayed, Missing due to caries, and Filled teeth in the permanent teeth/decayed, missing due to caries, and filled teeth in the deciduous teeth (DMFT/dmft index) values and International Caries Detection and Assessment System (ICDAS II) and radiographic evaluation criteria. In the experimental group, stainless steel crowns were placed on the teeth of 39 participants using the Hall technique. In the control group, stainless steel crowns were placed on the teeth of 39 participants using conventional technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hall technique | Experimental | Procedure: Hall techniqueIn the Hall technique method, an orthodontic separator was placed 2 days before the procedure to create distance for the crown in the mesial and distal contact areas of the tooth on which the crown will be placed. A stainless steel crown was cemented on the tooth with glass ionomer cement without local anesthesia, caries cleaning or any preparation. The participant was asked to close the teeth tightly for 2-3 minutes. |
| Conventional technique | Active comparator | Procedure: Conventional techniqueIn the conventional technique, after the area to be anesthetized was dried, topical anesthetic solution (Locanest 10% spray lidocaine, Avixa, Turkey) was applied to the mucosa with a cotton pellet for one minute. For infiltrative anesthesia, 4% articaine solution (Ultracaine DS Forte ampoule, Sanofi-Aventis GmbH, Germany) containing 1 ml of 1:100,000 epinephrine was applied. Preparation was made on the mesial, distal and occlusal sides of the tooth. The decay was cleaned and the cavity was filled with glass ionomer cement (Ketac Molar Easymix, 3M™ ESPE™, St. Paul, MN, USA). The stainless steel crown was bonded with glass ionomer cement (Ketac Cem Easymix, 3M™ ESPE™, St. Paul, MN, USA). |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects with American Society of Anesthesiologists score I (ASA I),
- Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
- Clinically, Black class II enamel-dentin caries in the upper jaw primary second molar is; ICDAS II Scale score 4, score 5 and the accepted values in the evaluation of radiographic dental caries are D1-RA3, D2-RB4, D3-RC5,
- Antagonist of the tooth planned to be processed,
- Lamina dura and periodontal space can be observed normally
Key exclusion criteria (5 listed)
- Allergic to the local anesthetics or sulfites,
- Had teeth with pain or sepsis,
- Were uncooperative during clinical examination,
- TMJ disorder,
- Had parafunctional habit
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 techniquePrepless crown technique | Procedure or surgery | Hall technique |
| Conventional technique1 or 1,5 mm preparation on mesial, distal and occlusal of the tooth | Procedure or surgery | Conventional technique |
Primary outcome
The measurement of intrusion of teeth with stainless steel crown applied with Hall technique using Gom Inspect
Time frame: Immediately before the procedure and one month control
Intrusion scores in Hall technique 0-3, where 0 means no movement, 3 means intrusion
The measurement of intrusion of teeth with stainless steel crown applied with conventional technique using Gom Inspect
Time frame: Immediately before the procedure and one month control
0-3, where 0 means no movement, 3 means extrusion
Change from measurement the distance between the cusps of canines with stainless steel crown applied with Hall technique using Exocad
Time frame: Immediately before the procedure and one month control
0-2, where 0 means no movement, 2 means no closure
Change from measurement the distance between the cusps of canines with stainless steel crown applied with conventional technique using Exocad
Time frame: Immediately before the procedure and one month control
0-2, where 0 means no movement, 2 means no closure
2 secondary outcomes
Measuring the impact of stainless steel crowns on oral health and quality of life in children section with the Early Childhood Oral Health Impact Scale
Time frame: Immediately after the procedure and one month control
Measuring the impact of stainless steel crowns on oral health and quality of life in parents section with the Early Childhood Oral Health Impact Scale
Time frame: Immediately after the procedure and one month control
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 30 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Conventional technique in people with Child, Only and Quality of Life, run by Izmir Katip Celebi 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 6 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: finished, as of the sponsor's last update on 30 Jan 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 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 measurement of intrusion of teeth with stainless steel crown applied with Hall technique using Gom Inspect (time frame: Immediately before the procedure and one month control). 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 30 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.