Deep CariesPhase 4NCT04397094
Theracal Pulpotomy in Primary Molars
A Phase 4 study testing Theracal LC and Formocresol in people with Deep Caries, run by Ain Shams University at 1 site in Egypt.
Trial summary
Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars. 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?
- Theracal LC and Formocresol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 30 Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- healthy, cooperative children
- mandibular primary molars with vital pulp exposures
Who cannot join
- clinical or radiographic evidence of irreversible pulpitis
- physiological root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Theracal Versus Formocresol Pulpotomy in Primary Molars
Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.
Read the detailed description
sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.
- Conditions
- Deep Caries
- Being tested
- Theracal LC, Formocresol
- Keywords
- Theracal, formocresol, pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theracal LCDrug
pulpotomy
FormocresolDrug
Pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| Theracal LC | Experimental | Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Receives: Drug: Theracal LC |
| Formocresol | Active comparator | Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Receives: Drug: Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Examination
Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.
Measured: 12 months
Secondary outcomes (1)
Radiographic Examination
Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space.
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 posted21 May 2020
- Study start1 Dec 2017
- Primary completion17 Mar 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariem Wassel, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397094
- Sponsor's protocol ID
- FDASU-Rec ID 101612
- Status last verified
- Jul 2020
- First submitted
- 17 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theracal Versus Formocresol Pulpotomy in Primary Molars
- ClinicalTrials.gov ID
- NCT04397094
- Acronym / sponsor ID
- FDASU-Rec ID 101612
- Conditions
- Deep Caries
- Keywords
- Theracal, formocresol, pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 17 Mar 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.
Detailed description
sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theracal LC | Experimental | Drug: Theracal LCTheracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. |
| Formocresol | Active comparator | Drug: FormocresolFormocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy, cooperative children
- mandibular primary molars with vital pulp exposures
Key exclusion criteria (2 listed)
- clinical or radiographic evidence of irreversible pulpitis
- physiological 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 |
|---|---|---|
| Theracal LCpulpotomy | Drug | Theracal LC |
| FormocresolPulpotomy | Drug | Formocresol |
Primary outcome
Clinical Examination
Time frame: 12 months
Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.
1 secondary outcome
Radiographic Examination
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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 Phase 4 study testing Theracal LC and Formocresol in people with Deep Caries, run by Ain Shams 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 2 inclusion and 2 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 29 Jul 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.
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?
Yes. Results are posted in the registry (first posted 29 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Examination (time frame: 12 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 29 Jul 2020.