- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05265104
Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth (SDF)
April 7, 2022 updated by: Rasha Farouk Sharaf, National Research Centre, Egypt
Clinical and Radiographic Evaluation of the Efficacy of Laser Versus Silver Diamine Flouride (SDF) in Hall Technique in Primary Teeth
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
Study Overview
Status
Active, not recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Dr. Rasha Farouk Sharaf
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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
|
Experimental: Diode laser with stainless steel crown
Diode laser beam is used to sterilize the carious lesions to arrest the progress of the dental caries
|
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
|
Active Comparator: 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.
|
the primary molars with carious lesions will be sealed with stainless steel crowns following the concept of hall technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on biting
Time Frame: 1 year
|
Verbal questioning of the patient
|
1 year
|
gingival swelling
Time Frame: 1 year
|
visual examination by the operator
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periapical/ furcation radiolucency
Time Frame: 1 year
|
perapical radiograph using paralleling technique by DE GOTZEN XGENUS intra-oral x ray unit
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rasha Sharaf, PhD, Researcher at the National Research Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2021
Primary Completion (Anticipated)
April 1, 2022
Study Completion (Anticipated)
April 30, 2022
Study Registration Dates
First Submitted
February 3, 2022
First Submitted That Met QC Criteria
February 22, 2022
First Posted (Actual)
March 3, 2022
Study Record Updates
Last Update Posted (Actual)
April 11, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1434052021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carious Teeth
-
Assistance Publique - Hôpitaux de ParisUniversity Hospital, Clermont-Ferrand; Rennes University Hospital; Nantes University...UnknownInflammatory Pulp Diseases Related to Carious TeethFrance
-
Samara State Medical UniversityActive, not recruitingCarious and Non-carious Lesions of the TeethRussian Federation
-
Cairo UniversityUnknown
-
Al-Azhar UniversityRecruitingDental Wear | Carious ToothEgypt
-
Marmara UniversityNot yet recruiting
-
Mansoura UniversityActive, not recruiting
-
Cairo UniversityUnknown
-
Marmara UniversityNot yet recruiting
-
Minia UniversityCompleted
-
Jordan University of Science and TechnologyActive, not recruiting
Clinical Trials on SDF with stainless steel crown
-
Suez Canal UniversityCompletedCaries of InfancyEgypt
-
NuSmile, Ltd.Unknown
-
Virginia Commonwealth UniversityNot yet recruitingDental Caries | Tooth DecayUnited States
-
King Abdulaziz UniversityCompletedTooth Diseases
-
Marmara UniversityNot yet recruiting
-
Marmara UniversityNot yet recruiting
-
TC Erciyes UniversityCompleted
-
Sondos NaserallahNot yet recruiting
-
Al-Azhar UniversityUnknownPlaque Accumulation | Pocket Depth | Gigival BleedingEgypt
-
Bahçeşehir UniversityCompletedDental Caries | Caries; DentinTurkey