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

June 1, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: 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
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
Device: 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
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.
Other: stainless steel crown only
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Research Centre, Egypt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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