Usage of Stainless Steel Crown on Primary Molars Using Ha... | NCT04201301

Studies
Usage of Stainless Steel Crown on Primary Molars Using Hall Technique

NCT04201301

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Dec 18, 2019Actual

Enrollment

164Estimated

Phase

Not provided

Conditions

Knowledge, Attitudes, Practice

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Estimated

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Aug 1, 2020Estimated

First Submitted Date

Dec 12, 2019

First Submission Date that Met QC Criteria

Dec 13, 2019

First Posted Date

Dec 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2019

Last Update Posted Date

Dec 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Rationale: Gaining information about the knowledge, practice and attitude regarding hall technique and find out how much the Egyptian dentists use this method for treatment the carious primary teeth.

Aim of the study: To assess the knowledge, practice and attitude of Egyptian dentists regarding non invasive restorative approach.

Detailed Description

The first study on the Hall Technique was published in 2006 . It was a retrospective study which analysed the practice records of a general dental practitioner from Scotland, Dr. Norna Hall. Dr. Hall simplified the standard technique to restore primary teeth using preformed SSCs and used it with her patients. This retrospective study involved a total of 978 crowns fitted in 259 children using her novel technique (today known as the Hall Technique). Most crowns were placed when there was clinical evidence of a proximal carious lesion into dentine and marginal ridge breakdown. This study showed the Hall Technique to have comparable outcomes to those achieved with other more conventional restorations.

Since then, growing understanding that caries is essentially a biofilm driven disease rather than an infectious disease, explains why the Hall Technique, and other 'sealing in' carious lesion techniques, are successful. The intervening ten years has seen robust evidence from several randomised control trials that are either completed or underway. These have found the Hall Technique superior to comparator treatments, with success rates (no pain or infection) of 99% (UK study) and 100% (Germany) at one year, 98% and 93% over two years (UK and Germany) and 97% over five years (UK). The Hall Technique is now regarded as one of several biological management options for carious lesions in primary molars.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

164Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
knowledge, practice and attitude of Egyptian Dentists regarding The Hall techniqu	Measuring device: KAP Questionnare Measuring unit: Binary(Yes,No) + Multiple Choice Questions (MCQ).	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Egyptian dentists.
Pediatric dentists ( having PhD).
Pediatric dentists (having Master degree or studying master degree) .

Exclusion Criteria:

dentists in other dental speciality.
dental students.
pediatric dentists who have not enough knowledge about hall technique.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All Egyptian Paediatric in Hospitals and health care units

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Mohamed El Shafie, Dr	Contact	01060977233		Mahmoud.ebead@dentistry.cu.edu.eg
Manal Ahmed Mofeed El-Sheikh, professor	Contact			manal_elshiekh98@hotmail.com

Overall Officials

Name	Affiliation	Role
faculty of dentistry cairo university, college	Cairo University	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28336976	Background	Innes NP, Evans DJ, Bonifacio CC, Geneser M, Hesse D, Heimer M, Kanellis M, Machiulskiene V, Narbutaite J, Olegario IC, Owais A, Araujo MP, Raggio DP, Splieth C, van Amerongen E, Weber-Gasparoni K, Santamaria RM. The Hall Technique 10 years on: Questions and answers. Br Dent J. 2017 Mar 24;222(6):478-483. doi: 10.1038/sj.bdj.2017.273.
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