Parental Satisfaction of Hall Technique for Caries Management in Primary Molars

NCT ID: NCT07148401

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-08-30

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hall technique

stainless steel crown is inserted on indicated carious primary molars without tooth preparation

Group Type ACTIVE_COMPARATOR

Hall technique

Intervention Type DEVICE

Hall technique for placement of crowns on carious primary molars

Interventions

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Hall technique

Hall technique for placement of crowns on carious primary molars

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Lamia Mohamed Khairy Gadallah

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Research Centre

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Lamia K Gadallah, Researcher

Role: CONTACT

002 01001020605

Facility Contacts

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Lamia K Gadallah

Role: primary

00201001020605

References

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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.

Reference Type BACKGROUND
PMID: 36185501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28336976 (View on PubMed)

Innes NP, Evans DJ. Modern approaches to caries management of the primary dentition. Br Dent J. 2013 Jun;214(11):559-66. doi: 10.1038/sj.bdj.2013.529.

Reference Type BACKGROUND
PMID: 23744209 (View on PubMed)

Other Identifiers

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18427

Identifier Type: -

Identifier Source: org_study_id

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