NCT05265104

Brief Summary

The hall technique for primary teeth depends on the idea of isolation of the carious non exposed primary tooth from all bacteria present in the oral cavity by using a stainless-steel crown which result in arresting of the caries and preventing its progress to the pulp. Recently laser and Silver Diamide Fluoride (SDF) have been used to arrest the progress of caries so in the current study we will compare the success rate of hall technique with either laser or SDF in arresting of caries

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

February 3, 2022

Last Update Submit

June 1, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain on biting

    Verbal questioning of the patient

    1 year

  • gingival swelling

    visual examination by the operator

    1 year

Secondary Outcomes (1)

  • Periapical/ furcation radiolucency

    1 year

Study Arms (3)

SDF with stainless steel crown

EXPERIMENTAL

mixture of silver , diamine and fluoride applied using a brush to the caries in the primary molar , it is used to arrest the progress of the carious lesion

Drug: SDF with stainless steel crown

Diode laser with stainless steel crown

EXPERIMENTAL

Diode laser beam is used to sterilize the carious lesions to arrest the progress of the dental caries

Device: Diode laser application with stainless steel crown

Control, stainless steel crown only

ACTIVE COMPARATOR

stainless steel crown is cemented on the carious primary molar to arrest the progress of the caries, by isolating the tooth from the surrounding bacteria, this is the concept of the Hall technique.

Other: stainless steel crown only

Interventions

Silver Diamine Fluoride (38%) applied to the carious lesion in the primary molars with a brush and the tooth is sealed with a stainless steel crown

SDF with stainless steel crown

Diode laser will be applied to the carious lesions primary molars to eradicate the bacteria and then the tooth will be sealed with stainless steel crown

Diode laser with stainless steel crown

the primary molars with carious lesions will be sealed with stainless steel crowns following the concept of hall technique

Control, stainless steel crown only

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients should be medically free
  • Presence of asymptomatic enamel and dentin caries in one or more primary molars, which can be detected clinically and radiographically
  • Periapical radiograph should show caries involving the outer half of the dentin
  • There should be no signs or symptoms of pulpal pathosis

You may not qualify if:

  • Immunocompromised patients
  • Presence of any signs or symptoms of pulpal pathosis denoting irreversible pulpitis
  • Parents who are not willing to come in the follow up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Rasha Farouk Sharaf

Cairo, Egypt

Location

Related Publications (5)

  • Chaurasiya A, Gojanur S. Evaluation of the clinical efficacy of 38% silver diamine fluoride in arresting dental caries in primary teeth and its parental acceptance. J Indian Soc Pedod Prev Dent. 2021 Jan-Mar;39(1):85-89. doi: 10.4103/jisppd.jisppd_34_21.

    PMID: 33885393BACKGROUND
  • Altoukhi DH, El-Housseiny AA. Hall Technique for Carious Primary Molars: A Review of the Literature. Dent J (Basel). 2020 Jan 17;8(1):11. doi: 10.3390/dj8010011.

  • Clark W, Geneser M, Owais A, Kanellis M, Qian F. Success rates of Hall technique crowns in primary molars: a retrospective pilot study. Gen Dent. 2017 Sep-Oct;65(5):32-35.

  • Crystal YO, Niederman R. Evidence-Based Dentistry Update on Silver Diamine Fluoride. Dent Clin North Am. 2019 Jan;63(1):45-68. doi: 10.1016/j.cden.2018.08.011.

  • Chokhachi Zadeh Moghadam N, Seraj B, Chiniforush N, Ghadimi S. Effects of Laser and Fluoride on the Prevention of Enamel Demineralization: An In Vitro Study. J Lasers Med Sci. 2018 Summer;9(3):177-182. doi: 10.15171/jlms.2018.32. Epub 2018 Jul 28.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Rasha Sharaf, PhD

    Researcher at the National Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher of Pediatric Dentistry

Study Record Dates

First Submitted

February 3, 2022

First Posted

March 3, 2022

Study Start

March 10, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations