Deep CariesPhase 4NCT03568474
Silver Diamine Fluoride After Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries
A Phase 4 study testing Silver Diamine Fluoride and Glass Ionomer in people with Deep Caries, run by Cairo University.
Trial summary
This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Silver Diamine Fluoride and Glass Ionomer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Apr 2020
- Phase
- Phase 4
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients free from any systematic diseases.
- Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.
- Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
- The absence of clinical symptoms of irreversible pulpitis.
- Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).
- Compliant patient/ parent.
Who cannot join
- Teeth with previous restorative treatment.
- Unrestorable teeth.
- Uncooperative patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study.
This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex
Read the detailed description
The study will be carried on young permanent molars with open apices \& with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.
- Conditions
- Deep Caries
- Being tested
- Silver Diamine Fluoride, Glass Ionomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDrug
Also called SDF
Indirect pulp capping material
Glass IonomerDrug
Also called GI
Indirect pulp capping material
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Silver Diamine fluoride will be applied after after minimal caries removal then glass ionomer over it followed by composite resin restoration. Receives: Drug: Silver Diamine Fluoride; Drug: Glass Ionomer |
| Glass Ionomer | Active comparator | Glass ionomer will be applied after minimal caries removal followed by composite resin restoration. Receives: Drug: Glass Ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)
Measured: 9 months
Secondary outcomes (4)
Tooth vitality
Will be assessed by Vitality test using thermal stimulation, binary (yes or no)
Measured: 9 months
Abscess
Will be assessed intraoral Clinical examination whether there is swelling or not, binary (yes or no)
Measured: 9 months
Pain on percussion
Will be assessed by Percussion test by using the back of the mirror on the tooth, binary (yes or no)
Measured: 9 months
Root lengthening
Will be assessed measuring the root length by mm on the digital radiography (digora software)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionApr 2020 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel two arm groups with 1:1 allocation ratio
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehan Anwar Ibrahim, Cairo University
- Investigators
- Nevine G Waly, Professor, Study chair, Pediatric Dentistry, Faculty of Dentistry, Cairo UniversitySara A Mahmoud, PhD, Study director, Pediatric Dentistry, Faculty of Dentistry, Cairo UniversityMohamed K Zayt, PhD, Study director, Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo UniversityRehan A Ibrahim, MSc, Principal investigator, Pediatric Dentistry, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568474
- Sponsor's protocol ID
- Egypt Cairo University
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: thesis and article publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT03568474
- Acronym / sponsor ID
- Egypt Cairo University
- Conditions
- Deep Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 26 Jun 2018 (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.
This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex
Detailed description
The study will be carried on young permanent molars with open apices \& with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel two arm groups with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Drug: Silver Diamine Fluoride, Drug: Glass IonomerSilver Diamine fluoride will be applied after after minimal caries removal then glass ionomer over it followed by composite resin restoration. |
| Glass Ionomer | Active comparator | Drug: Glass IonomerGlass ionomer will be applied after minimal caries removal followed by composite resin restoration. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients free from any systematic diseases.
- Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.
- Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
- The absence of clinical symptoms of irreversible pulpitis.
- Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).
Key exclusion criteria (3 listed)
- Teeth with previous restorative treatment.
- Unrestorable teeth.
- Uncooperative patients.
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 |
|---|---|---|
| Silver Diamine FluorideAlso: SDFIndirect pulp capping material | Drug | Silver Diamine Fluoride |
| Glass IonomerAlso: GIIndirect pulp capping material | Drug | Glass Ionomer, Silver Diamine Fluoride |
Primary outcome
Postoperative Pain
Time frame: 9 months
Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)
4 secondary outcomes
Tooth vitality
Time frame: 9 months
Abscess
Time frame: 9 months
Pain on percussion
Time frame: 9 months
Root lengthening
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Yes. thesis and article publication
Related trials for Deep Caries
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
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Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
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.
Nevine G Waly, Professor study chair
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Sara A Mahmoud, PhD study director
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Mohamed K Zayt, PhD study director
Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silver Diamine Fluoride and Glass Ionomer in people with Deep Caries, run by Cairo University.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rehan Anwar, MSc (+201210339553, rehananwar28@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 9 months). 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 26 Jun 2018.