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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03433157
Other study ID # Hall vs SSC
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date December 2024

Study information

Verified date March 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hall technique
Metal Stainless stain crown placed with Hall technique
Traditional technique
Metal Stainless stain crown placed with Traditional technique

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
2 years
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