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Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth (SDF)

Primary Purpose

Carious Teeth

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SDF with stainless steel crown
Diode laser application with stainless steel crown
stainless steel crown only
Sponsored by
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carious Teeth

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Rasha Farouk Sharaf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

SDF with stainless steel crown

Diode laser with stainless steel crown

Control, stainless steel crown only

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Pain on biting
Verbal questioning of the patient
gingival swelling
visual examination by the operator

Secondary Outcome Measures

Periapical/ furcation radiolucency
perapical radiograph using paralleling technique by DE GOTZEN XGENUS intra-oral x ray unit

Full Information

First Posted
February 3, 2022
Last Updated
April 7, 2022
Sponsor
National Research Centre, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05265104
Brief Title
Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth
Acronym
SDF
Official Title
Clinical and Radiographic Evaluation of the Efficacy of Laser Versus Silver Diamine Flouride (SDF) in Hall Technique in Primary Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SDF with stainless steel crown
Arm Type
Experimental
Arm Description
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
Arm Title
Diode laser with stainless steel crown
Arm Type
Experimental
Arm Description
Diode laser beam is used to sterilize the carious lesions to arrest the progress of the dental caries
Arm Title
Control, stainless steel crown only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SDF with stainless steel crown
Intervention Description
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
Device
Intervention Name(s)
Diode laser application with stainless steel crown
Intervention Description
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
Other
Intervention Name(s)
stainless steel crown only
Intervention Description
the primary molars with carious lesions will be sealed with stainless steel crowns following the concept of hall technique
Primary Outcome Measure Information:
Title
Pain on biting
Description
Verbal questioning of the patient
Time Frame
1 year
Title
gingival swelling
Description
visual examination by the operator
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Periapical/ furcation radiolucency
Description
perapical radiograph using paralleling technique by DE GOTZEN XGENUS intra-oral x ray unit
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasha Sharaf, PhD
Organizational Affiliation
Researcher at the National Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Rasha Farouk Sharaf
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33885393
Citation
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.
Results Reference
background
PubMed Identifier
31963463
Citation
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.
Results Reference
result
PubMed Identifier
28862586
Citation
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.
Results Reference
result
PubMed Identifier
30447792
Citation
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.
Results Reference
result
PubMed Identifier
30809328
Citation
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.
Results Reference
result

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Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth

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