Deep CariesNCT03032978
Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment
A study testing Calcium hydroxide and Calcium silicate in people with Deep Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in two-step indirect pulp treatment: Randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Calcium hydroxide and Calcium silicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2018to 15 May 2019
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years.
- Males or females.
- Co-operative patients approving to participate in the trial.
Who cannot join
- Patients younger than 19 years old or older than 50 years old.
- Disabilities.
- Systemic diseases or severe medically compromised.
- Lack of compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Evaluation of Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment: Randomized Clinical Trial
Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in two-step indirect pulp treatment: Randomized clinical trial
- Conditions
- Deep Caries
- Being tested
- Calcium hydroxide, Calcium silicate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxideOther
Also called Dycal
Pulp capping material
Calcium silicateOther
Also called Theracal
Pulp capping material
| Study group | Role | What they receive |
|---|---|---|
| Calcium silicate | Experimental | intervention Receives: Other: Calcium silicate |
| Calcium Hydroxide | Active comparator | Comparator Receives: Other: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: VAS
post operative pain after 6 month from material application will be measured by visual analogue scale (VAS)with score from 0 to 10 in which 0 means no pain and 10 means the worst pain
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start20 Apr 2018
- Primary completion1 Mar 2019
- Study completion15 May 2019
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
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ehsan hossam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032978
- Sponsor's protocol ID
- CEBD-CU-2017-01-06
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation of Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03032978
- Acronym / sponsor ID
- CEBD-CU-2017-01-06
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in two-step indirect pulp treatment: Randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium silicate | Experimental | Other: Calcium silicateintervention |
| Calcium Hydroxide | Active comparator | Other: Calcium hydroxideComparator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years.
- Males or females.
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (4 listed)
- Patients younger than 19 years old or older than 50 years old.
- Disabilities.
- Systemic diseases or severe medically compromised.
- Lack of compliance.
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 |
|---|---|---|
| Calcium hydroxideAlso: DycalPulp capping material | Other | Calcium Hydroxide |
| Calcium silicateAlso: TheracalPulp capping material | Other | Calcium silicate |
Primary outcome
Pain: VAS
Time frame: 6 month
post operative pain after 6 month from material application will be measured by visual analogue scale (VAS)with score from 0 to 10 in which 0 means no pain and 10 means the worst pain
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 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Deep Caries
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Recruiting
"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
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.
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 Calcium hydroxide and Calcium silicate 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 3 inclusion and 4 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 27 Jan 2020. 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: VAS (time frame: 6 month). 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 27 Jan 2020.