Deep CariesNCT05425368
Comparing Two Indirect Pulp Capping Agents for Permanent Teeth
A study testing Silver diamine fluoride and Mineral trioxide aggregate in people with Deep Caries, run by Cairo University.
Trial summary
Aim of the study: To evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Deep Caries
- What is being tested?
- Silver diamine fluoride and Mineral trioxide aggregate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to Dec 2023
- 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient and parent showing cooperation and compliance.
- Children 9-14 years old
- Vital deeply carious young first permanent molar(s) with complete root formation
- Asymptomatic teeth or without clinical symptoms of spontaneous pain
- Both genders will be included.
Who cannot join
- Children unable to return for recall visits.
- Any clinical signs of irreversible pulpitis or pulp necrosis (spontaneous pain, pain on percussion, abscess, sinus).
- Any radiographic sign of irreversible pulp pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)
Trial locations and contacts
No sites are listed yet.
Randa Youssef Abd Al Gawad contact
About this study
Official title: Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Mineral Trioxide Aggregate as Indirect Pulp Capping Agents in Deeply Carious Young Permanent Molars Randomized Controlled Clinical Trial
Aim of the study:
To evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars.
Read the detailed description
Indirect pulp treatment has become a common maneuver in vital pulp therapy in recent years and is a procedure performed in teeth with deep carious lesions approximating the pulp but without any signs or symptoms of irreversible pulpal changes.
Silver Diamine Fluoride is used to arrest caries lesions in primary teeth but according to the AAPD,2021 more research is needed on the use of SDF to arrest caries lesions in permanent teeth.
- Conditions
- Deep Caries
- Being tested
- Silver diamine fluoride, Mineral trioxide aggregate
- Keywords
- partial caries removal, indirect pulp capping, fluorides
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
First permanent molars in this group will receive 38% silver diamine fluoride as an indirect pulp capping material.
Mineral trioxide aggregateDrug
Also called MTA
First permanent molars in this group will receive mineral trioxide aggregate as an indirect pulp capping material.
| Study group | Role | What they receive |
|---|---|---|
| silver diamine fluoride group | Experimental | partial caries removal will be carried out then Silver Diamine Fluoride will be applied as indirect pulp capping agent and rubbed for 1 minute followed by Glass ionomer filling Receives: Drug: Silver diamine fluoride |
| mineral trioxide aggregate group | Active comparator | partial caries removal will be carried out then mineral trioxide aggregate will be placed as indirect pulp capping agent followed by glass ionomer filling Receives: Drug: Mineral trioxide aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin bridge formation
Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination
Measured: 6 months
Secondary outcomes (4)
Postoperative pain
Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)
Measured: 1 week
Absence of sinus or fistula
Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)
Measured: 3 months
Absence of sinus or fistula
Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)
Measured: 6 months
radiographic success
Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones will be assessed if present or absent by digital radiographic examination, Binary (present or absent)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Ahmed Zaghloul, Cairo University
- Investigators
- Manal Ahmed El Sayed, Principal investigator, Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo UniversityRanda Youssef Abd Al Gawad, Principal investigator, Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425368
- Sponsor's protocol ID
- Indirect pulp capping
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Mineral Trioxide Aggregate as Indirect Pulp Capping Agents in Deeply Carious Young Permanent Molars Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05425368
- Acronym / sponsor ID
- Indirect pulp capping
- Conditions
- Deep Caries
- Keywords
- partial caries removal, indirect pulp capping, fluorides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Jun 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.
Aim of the study:
To evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars.
Detailed description
Indirect pulp treatment has become a common maneuver in vital pulp therapy in recent years and is a procedure performed in teeth with deep carious lesions approximating the pulp but without any signs or symptoms of irreversible pulpal changes.
Silver Diamine Fluoride is used to arrest caries lesions in primary teeth but according to the AAPD,2021 more research is needed on the use of SDF to arrest caries lesions in permanent teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silver diamine fluoride group | Experimental | Drug: Silver diamine fluoridepartial caries removal will be carried out then Silver Diamine Fluoride will be applied as indirect pulp capping agent and rubbed for 1 minute followed by Glass ionomer filling |
| mineral trioxide aggregate group | Active comparator | Drug: Mineral trioxide aggregatepartial caries removal will be carried out then mineral trioxide aggregate will be placed as indirect pulp capping agent followed by glass ionomer filling |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient and parent showing cooperation and compliance.
- Children 9-14 years old
- Vital deeply carious young first permanent molar(s) with complete root formation
- Asymptomatic teeth or without clinical symptoms of spontaneous pain
- Both genders will be included.
Key exclusion criteria (3 listed)
- Children unable to return for recall visits.
- Any clinical signs of irreversible pulpitis or pulp necrosis (spontaneous pain, pain on percussion, abscess, sinus).
- Any radiographic sign of irreversible pulp pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)
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: SDFFirst permanent molars in this group will receive 38% silver diamine fluoride as an indirect pulp capping material. | Drug | silver diamine fluoride group |
| Mineral trioxide aggregateAlso: MTAFirst permanent molars in this group will receive mineral trioxide aggregate as an indirect pulp capping material. | Drug | mineral trioxide aggregate group |
Primary outcome
Dentin bridge formation
Time frame: 6 months
Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination
4 secondary outcomes
Postoperative pain
Time frame: 1 week
Absence of sinus or fistula
Time frame: 3 months
Absence of sinus or fistula
Time frame: 6 months
radiographic success
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
Randa Youssef Abd Al Gawad contact
Manal Ahmed El Sayed principal investigator
Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Randa Youssef Abd Al Gawad principal investigator
Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Silver diamine fluoride and Mineral trioxide aggregate 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 5 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 21 Jun 2022. 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.
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 Marwa Ahmed Ahmed Zaghloul (+201002798304, marwa_zaghloul@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin bridge formation (time frame: 6 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 21 Jun 2022.