Carious TeethSDFNCT05265104
Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth
A study testing SDF with stainless steel crown, Diode laser application with stainless steel crown and stainless steel crown only in people with Carious Teeth, run by National Research Centre, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Teeth
- What is being tested?
- SDF with stainless steel crown, Diode laser application with stainless steel crown and stainless steel crown only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Carious Teeth
- Being tested
- SDF with stainless steel crown, Diode laser application with stainless steel crown, stainless steel crown only
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF with stainless steel crownDrug
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 application with stainless steel crownDevice
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
stainless steel crown onlyOther
the primary molars with carious lesions will be sealed with stainless steel crowns following the concept of hall technique
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: stainless steel crown only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on biting
Verbal questioning of the patient
Measured: 1 year
gingival swelling
visual examination by the operator
Measured: 1 year
Secondary outcomes (1)
Periapical/ furcation radiolucency
perapical radiograph using paralleling technique by DE GOTZEN XGENUS intra-oral x ray unit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start10 Mar 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carious TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Farouk Sharaf, National Research Centre, Egypt
- Investigators
- Rasha Sharaf, PhD, Principal investigator, Researcher at the National Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265104
- Sponsor's protocol ID
- 1434052021
- Acronym
- SDF
- Status last verified
- Jun 2024
- First submitted
- 3 Feb 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33885393Altoukhi 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.
PubMed 31963463Clark 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.
PubMed 28862586Crystal 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.
PubMed 30447792Chokhachi 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.
PubMed 30809328
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Efficacy of Laser Versus Silver Diamine Flouride (SDF) in Hall Technique in Primary Teeth
- ClinicalTrials.gov ID
- NCT05265104
- Acronym / sponsor ID
- SDF / 1434052021
- Conditions
- Carious Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SDF with stainless steel crown | Experimental | Drug: SDF with stainless steel crownmixture 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 with stainless steel crown | Experimental | Device: Diode laser application with stainless steel crownDiode laser beam is used to sterilize the carious lesions to arrest the progress of the dental caries |
| Control, stainless steel crown only | Active comparator | Other: stainless steel crown onlystainless 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDF with stainless steel crownSilver 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 | Drug | SDF with stainless steel crown |
| Diode laser application with stainless steel crownDiode 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 | Device | Diode laser with stainless steel crown |
| stainless steel crown onlythe primary molars with carious lesions will be sealed with stainless steel crowns following the concept of hall technique | Other | Control, stainless steel crown only |
Primary outcome
Pain on biting
Time frame: 1 year
Verbal questioning of the patient
gingival swelling
Time frame: 1 year
visual examination by the operator
1 secondary outcome
Periapical/ furcation radiolucency
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 33885393Chaurasiya 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 publication: PubMed 31963463Altoukhi 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 publication: PubMed 28862586Clark 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 publication: PubMed 30447792Crystal 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 publication: PubMed 30809328Chokhachi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasha Sharaf, PhD principal investigator
Researcher at the National Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDF with stainless steel crown, Diode laser application with stainless steel crown and stainless steel crown only in people with Carious Teeth, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on biting (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265104, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.