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Not yet recruiting NCT07148401

Parental Satisfaction of Hall Technique for Caries Management in Primary Molars

No phase Interventional Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hall technique.
Who it may be relevant to
Registry conditions: Dental Caries. Basic parameters: 4 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Parental and Patient Satisfaction of Hall Technique for Caries Management in Primary Molars

Overview

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.

Interventions

  • Device Hall technique
    Hall technique for placement of crowns on carious primary molars

Primary outcome measures

  • Parental satisfaction [Time frame: at time of insertion, 2 weeks , 6 months, 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • National Research Centre — Cairo

Publications

  • 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. PMID 36185501
  • 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. PMID 28336976
  • 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. PMID 23744209

Identifiers

NCT: NCT07148401 · 18427

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗