- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07100028
- Original Trial
Hall Technique vs Conventional Technique in Permanent Teeth
Comparison of Hall Technique vs Conventional Technique in Permanent Teeth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stainless Steel Crowns will be applied on two permanent molar teeth in a split mouth design. 96 patients will be included in the study. The teeth will be randomized into two groups according to the applying methods: 1) Traditional method 2) Hall technique.
Oral hygiene index (Green & Vermillion), Plaque index (Sillness & Löe), gingival health (Löe & Sillness), level of gingival margin, crown retention and success, wear, occlusion, clinical pulpal health (spontaneous pain, mucosal swelling/fistula presence, mobility, percussion/palpation tenderness) and radiographic pulpal health (periradicular/interradicular radiolucency, lamina dura loss, internal/external root resorption, pulp canal obliteration) will be evaluated and photographic records will be taken.
The evaluation of the restorations will be performed at baseline, and 1., 3., 6., 12., 18., 24. months. The measurement of vertical hight on occlusion will be performed before and immediate after the treatment, at 2 weeks and 1., 2. and 3.months.
Fisher's Exact test, Kaplan-Meier Survival Curves, Log-rank test, Mann Whitney U test, and Friedman test will be performed for the statistical analysis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: gizem erbas unverdi, Dr.
- Phone Number: 00905052805736
- Email: erbasgizem@gmail.com
Study Contact Backup
- Name: sule sahin, research assistant
- Email: sahinsule02@gmail.com
Study Locations
-
-
Altindag
-
Ankara, Altindag, Turkey, 06100
- Hacettepe university, pediatric dentistry
-
Contact:
- gizem erbas unverdi, assoc.prof.
- Email: erbasgizem@gmail.com
-
Contact:
- sule sahin
-
Sub-Investigator:
- sule sahin
-
Principal Investigator:
- gizem erbas unverdi, assoc.prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The child volunteers and their parents who read and agreed to the informed consent form.
- The presence of excessive loss of material or extensive enamel defects in at least two permanent molars that require crown application.
- The presence of antagonist teeth of the teeth to be crowned.
- All treatments on the patient's other teeth have been completed.
- The patient who does not have temporomandibular joint (TMJ) problems.
- Children who have cooperation to allow the dental procedure to be completed.
Exclusion Criteria:
- Child volunteers or parents who refuse to participate in the study.
- The patient who has a chronic disease.
- Patients undergoing orthodontic treatment
- The patient has missing teeth on the treated side.
- The need for vital or non-vital pulp treatment of the tooth.
- The child volunteers and their parents did not accept the aesthetic appearance of the stainless steel crown.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SSC crown with conventional technique
SSC crown placement using conventional technique
|
SSC crown placement using Hall technique
|
|
Experimental: SSC crown with Hall technique
SSC crown placement using Hall technique
|
SSC placement using conventional technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical and radiological performance of SSCs placed with Hall of conventional technique
Time Frame: 2 years
|
The primary outcome 'success' was defined as the "absence of major failure," a measure encompassing clinical and radiographic signs of irreversible pulpitis or infectious complications (spontaneous pain, pulp infection, or periradicular pathology, loss of lamina dura on radiographs).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical measurements of SSCs placed with Hall of conventional technique
Time Frame: 2 years
|
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: zafer cavit cehreli, prof.dr.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hall technique-permanent
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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