Deep CariesRCTNCT04005872
Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment
A study testing Nano Silver Fluoride and Calcium hydroxide in people with Deep Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Nano Silver Fluoride and Calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Nov 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:
- Cooperative children.
- Both genders.
- In age range from 4 to 7 years.
- Teeth:
- Vital second primary molars with deep caries limited to occlusal surface.
Show all 9Show fewer
- No clinical signs or symptoms of irreversible pulpitis or pulp necrosis.
- No radiographic abnormalities
- Restorable teeth.
Who cannot join
- • Children with known history of allergy to any of the tested materials.
- Children with systemic conditions.
- Parents who refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial
The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.
Read the detailed description
This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015).
This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).
- Conditions
- Deep Caries
- Being tested
- Nano Silver Fluoride, Calcium hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano Silver FluorideDrug
Also called NSF
Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.
Calcium hydroxideDrug
Also called CaoH
Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.
| Study group | Role | What they receive |
|---|---|---|
| Nano Silver Fluoride | Experimental | 2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush Receives: Drug: Nano Silver Fluoride |
| Calcium Hydroxide | Active comparator | Calcium hydroxide placed on the last soft carious layer approaching the pulp Receives: Drug: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous pain or pain on biting
By asking patient
Measured: 12 months
Pain on percussion
By the back of mirror
Measured: 12 months
Swelling
Clinical examination by operator
Measured: 12 months
Mobility
Clinical examination by operator
Measured: 12 months
Sinus or fistula tract
Clinical examination by operator
Measured: 12 months
Secondary outcomes (3)
Furcation or perapical radiolucency
Periapical radiograph
Measured: 12 months
External or internal root resorption
Periapical radiograph
Measured: 12 months
Widening periodontal membrane space
Periapical radiograph
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Oct 2019
- Primary completion5 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Moahmed Fouad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005872
- Sponsor's protocol ID
- Cairo U E
- Acronym
- RCT
- Status last verified
- Dec 2022
- First submitted
- 27 Jun 2019
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical and Radiographic Evaluation of Nano Silver Fluoride versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04005872
- Acronym / sponsor ID
- RCT / Cairo U E
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Jul 2019 (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 management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.
Detailed description
This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015).
This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide
| Arm | Type | Receives |
|---|---|---|
| Nano Silver Fluoride | Experimental | Drug: Nano Silver Fluoride2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush |
| Calcium Hydroxide | Active comparator | Drug: Calcium hydroxideCalcium hydroxide placed on the last soft carious layer approaching the pulp |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Cooperative children.
- Both genders.
- In age range from 4 to 7 years.
- Vital second primary molars with deep caries limited to occlusal surface.
- No clinical signs or symptoms of irreversible pulpitis or pulp necrosis.
Key exclusion criteria (3 listed)
- • Children with known history of allergy to any of the tested materials.
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 |
|---|---|---|
| Nano Silver FluorideAlso: NSFNano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound. | Drug | Nano Silver Fluoride |
| Calcium hydroxideAlso: CaoHCalcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue. | Drug | Calcium Hydroxide |
Primary outcome
Spontaneous pain or pain on biting
Time frame: 12 months
By asking patient
Pain on percussion
Time frame: 12 months
By the back of mirror
Swelling
Time frame: 12 months
Clinical examination by operator
Mobility
Time frame: 12 months
Clinical examination by operator
Sinus or fistula tract
Time frame: 12 months
Clinical examination by operator
3 secondary outcomes
Furcation or perapical radiolucency
Time frame: 12 months
External or internal root resorption
Time frame: 12 months
Widening periodontal membrane space
Time frame: 12 months
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 20 Dec 2022.
- Individual participant dataSharing planned: No. Clinical and Radiographic Evaluation of Nano Silver Fluoride versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano Silver Fluoride and Calcium hydroxide in people with Deep Caries, run by Cairo University 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 9 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 20 Dec 2022. 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?
Spontaneous pain or pain on biting (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2022.