Parental Satisfaction of Hall Technique for Caries Manage... | NCT07148401

Studies
Parental Satisfaction of Hall Technique for Caries Management in Primary Molars

NCT07148401

Sponsor

National Research Centre, Egypt

Status

Not yet recruiting

Last Update Posted

Aug 29, 2025Actual

Enrollment

26Estimated

Phase

Not Applicable

Conditions

Dental Caries

Interventions

Hall technique

Countries

Egypt

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

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2025Estimated

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 30, 2026Estimated

First Submitted Date

Aug 23, 2025

First Submission Date that Met QC Criteria

Aug 28, 2025

First Posted Date

Aug 29, 2025Actual

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

Aug 28, 2025

Last Update Posted Date

Aug 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lamia Mohamed Khairy Gadallah, Researcher, National Research Centre, EgyptPrincipal Investigator

Lead Sponsor

National Research Centre, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As a newly introduced technique for caries management in primary teeth, patient-centered outcomes such as parental satisfaction, acceptability of the treatment and child discomfort needs to be investigated about Hall technique. Therefore , the aim of our study is to investigate parental and patient satisfaction of Hall technique in managing carious primary molars in children.

Detailed Description

Children included are those aged from 4 -10 years old. Children with one or more primary molar with class I and class II carious lesions, with no history of pain, or signs of reversible pulpitis .

Patients with signs of irreversible pulpitis as spontaneous pain or pain at night or pathological signs as periapical radiolucency and pathological root resorptions are excluded

Method:

Patient will receive no local anesthesia or tooth preparation. A proper sized preformed stainless-steel crown will be checked first. Then, the crown will be cemented on the tooth using glass ionomer cement The child is instructed to bite on the crown by means of a cotton roll. Excess cement was cleared immediately using a probe after cementation.

Primary outcome:

Parent satisfaction :

Parents satisfaction will be measured by a 5 point Likert scale with five possible answers: strongly agree, agree, neutral, disagree, and strongly disagree.[9]

Patient discomfort:

Discomfort at time of intervention: The Wong-Baker Faces Pain Scale will be used for assessment

Secondary outcomes:

Clinical evaluation will be performed at two-week interval, 6 and 12 months including :

Absence of adverse signs and symptoms of the carious lesion. Crown evaluation including crown retention.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hall technique	Active Comparator	stainless steel crown is inserted on indicated carious primary molars without tooth preparation	Device: Hall technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hall technique	Device	Hall technique for placement of crowns on carious primary molars	Hall technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parental satisfaction	Parents satisfaction will be measured by a 5 point Likert scale with five possible answers: strongly agree, agree, neutral, disagree, and strongly disagree	at time of insertion, 2 weeks , 6 months, 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with one or more primary molar with class I and class II carious lesions.
Teeth with no history of pain, or signs of reversible pulpitis

Exclusion Criteria:

Teeth with signs of irreversible pulpitis as spontaneous pain or pain at night.
Teeth with signs of non-vitality as presence of sinus or fistula or pathologic mobility.
Teeth with pathological radiographic signs as periapical radiolucency and pathological root resorptions.
Parental refusal for the use of stainless steel crown

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lamia K Gadallah, Researcher	Contact	002 01001020605		lm.khairy@nrc.sci.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Research Centre		Cairo		12622	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36185501	Background	Hu S, BaniHani A, Nevitt S, Maden M, Santamaria RM, Albadri S. Hall technique for primary teeth: A systematic review and meta-analysis. Jpn Dent Sci Rev. 2022 Nov;58:286-297. doi: 10.1016/j.jdsr.2022.09.003. Epub 2022 Sep 27.
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.

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases