Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth

NCT ID: NCT05265104

Last Updated: 2024-06-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2022-04-30

Brief Summary

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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

Detailed Description

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The high frequency of caries in primary teeth and its inadequate treatment are major public health problems during childhood. Nowadays, the Hall technique is one of the methods used for biological sealing in carious lesions in primary molars. Thus, the bacteria will be sealed from oral environment and the caries will be inactive. Using the Hall technique, the crown is placed without local anesthesia, caries removal, or tooth preparation. Then, the crown is fitted over the carious primary molar by either the dentist's finger pressure, or the child's biting force. The average results of many clinical trials showed that the success rates of the Hall technique were greater than the conventional restorations. However, some criteria of minor failures were seen in 26.6% of Hall crowns. Silver diamine fluoride (SDF), a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children, its effectiveness in reducing specific cariogenic bacteria and its remineralizing potential on enamel and dentin have been reported in many studies. Recently, lasers have been proven to significantly arrest the dental caries by increasing the acid resistance of the enamel with an antibacterial effect. Diode lasers with several positive aspects, such as the small size, low cost, and ease of use in the oral cavity, were found to have a caries prevention and arrest effect on the dental enamel, particularly deciduous teeth. In the current study the success rate of Hall technique using SDF will be compared to the same technique using Diode laser in arresting the carious lesions in primary teeth.

Conditions

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Carious Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SDF with stainless steel crown

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

Group Type EXPERIMENTAL

SDF with stainless steel crown

Intervention Type DRUG

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

Diode laser with stainless steel crown

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

Group Type EXPERIMENTAL

Diode laser application with stainless steel crown

Intervention Type DEVICE

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

Control, stainless steel crown only

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.

Group Type ACTIVE_COMPARATOR

stainless steel crown only

Intervention Type OTHER

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

Interventions

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SDF with stainless steel crown

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

Intervention Type DRUG

Diode laser application 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

Intervention Type DEVICE

stainless steel crown only

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Rasha Farouk Sharaf

Researcher of Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasha Sharaf, PhD

Role: PRINCIPAL_INVESTIGATOR

Researcher at the National Research Centre

Locations

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Dr. Rasha Farouk Sharaf

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 33885393 (View on PubMed)

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.

Reference Type RESULT
PMID: 31963463 (View on PubMed)

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.

Reference Type RESULT
PMID: 28862586 (View on PubMed)

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.

Reference Type RESULT
PMID: 30447792 (View on PubMed)

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.

Reference Type RESULT
PMID: 30809328 (View on PubMed)

Other Identifiers

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1434052021

Identifier Type: -

Identifier Source: org_study_id

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