Deep CariesPhase 4NCT05167123
Pulp Capping in Primary Molars Using TheraCal (LC)
A Phase 4 study testing Light cured tri-calcium silicate base material in people with Deep Caries and Indirect Pulp Capping, run by Ain Shams University at 3 sites in Egypt.
Trial summary
A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)). 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, Indirect Pulp Capping, Direct Pulp Capping
- What is being tested?
- Light cured tri-calcium silicate base material
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Sep 2019to 15 Dec 2021
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 4-7 years.
- Free medical history.
- Complete physical and mental health.
- Patient cooperation
- restorable mandibular primary molars
Who cannot join
- Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)
- Soft tissue swelling, draining fistula or sinus tracts.
- Tenderness to percussion.
- Pathological Tooth mobility.
- Widening of periodontal membrane space
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Ain Shams University Faculy of Dentistry
Cairo, 02112
Department of pediatric dentistry - Ain Shams University
Cairo, 02112
Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University
Cairo, 11566
About this study
Official title: Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)
A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).
Read the detailed description
Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.
- Conditions
- Deep Caries, Indirect Pulp Capping, Direct Pulp Capping, Reversible Pulpitis, Decayed Teeth, Vital Pulp Therapy
- Being tested
- Light cured tri-calcium silicate base material
- Keywords
- IPC , DPC
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light cured tri-calcium silicate base materialDrug
Also called TheraCal (LC)
TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe
| Study group | Role | What they receive |
|---|---|---|
| Indirect Pulp Capping | Experimental | TheraCal (LC) will be applied to affected dentin after excavation of infected dentin Receives: Drug: Light cured tri-calcium silicate base material |
| Direct Pulp Capping | Experimental | TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin. Receives: Drug: Light cured tri-calcium silicate base material |
What is being measured
The primary outcome is the main question the study is designed to answer.
recording signs and symptoms through clinical examination
All the primary molars participating in this study will be examined clinically under the illumination of dental unit, percussion and palpation test will be performed to ensure absence of any sign and symptoms of irreversible pulpitis or nectrotic pulp during follow -up period.
Measured: one year follow-up
Secondary outcomes (2)
recording pathological Changes in Radiographic examination
All the primary molars participating in this study will be examined radiographically every (3,6,9,12 months) to ensure the absence of any pathological changes .
Measured: one year follow-up
Evaluation of TheraCal (LC) as a pulp capping material
Clinical and radiographic examination will be done to each tooth participating in this study to evaluate the efficiency of TheraCal (LC) when used as a pulp capping material in primary molars .
Measured: one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Sep 2019
- Primary completion30 Nov 2021
- Study completion15 Dec 2021
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.
- 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
- Simple parallel randomization was performed by using computerized random numbers
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Hussein Moselhy, Ain Shams University
- Investigators
- Yomna Hussein Moselhy, M.Sc., Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167123
- Sponsor's protocol ID
- FDASU-RECIM041919
- Status last verified
- Feb 2023
- First submitted
- 28 Sep 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)
- ClinicalTrials.gov ID
- NCT05167123
- Acronym / sponsor ID
- FDASU-RECIM041919
- Conditions
- Deep Caries, Indirect Pulp Capping, Direct Pulp Capping, Reversible Pulpitis, Decayed Teeth, Vital Pulp Therapy
- Keywords
- IPC , DPC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 22 Dec 2021 (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.
A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).
Detailed description
Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Simple parallel randomization was performed by using computerized random numbers
| Arm | Type | Receives |
|---|---|---|
| Indirect Pulp Capping | Experimental | Drug: Light cured tri-calcium silicate base materialTheraCal (LC) will be applied to affected dentin after excavation of infected dentin |
| Direct Pulp Capping | Experimental | Drug: Light cured tri-calcium silicate base materialTheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 4-7 years.
- Free medical history.
- Complete physical and mental health.
- Patient cooperation
- restorable mandibular primary molars
Key exclusion criteria (5 listed)
- Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)
- Soft tissue swelling, draining fistula or sinus tracts.
- Tenderness to percussion.
- Pathological Tooth mobility.
- Widening of periodontal membrane space
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 |
|---|---|---|
| Light cured tri-calcium silicate base materialAlso: TheraCal (LC)TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe | Drug | Direct Pulp Capping, Indirect Pulp Capping |
Primary outcome
recording signs and symptoms through clinical examination
Time frame: one year follow-up
All the primary molars participating in this study will be examined clinically under the illumination of dental unit, percussion and palpation test will be performed to ensure absence of any sign and symptoms of irreversible pulpitis or nectrotic pulp during follow -up period.
2 secondary outcomes
recording pathological Changes in Radiographic examination
Time frame: one year follow-up
Evaluation of TheraCal (LC) as a pulp capping material
Time frame: one year follow-up
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 3 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Deep Caries
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Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
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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.
Yomna Hussein Moselhy, M.Sc. principal investigator
Ain Shams University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Light cured tri-calcium silicate base material in people with Deep Caries and Indirect Pulp Capping, run by Ain Shams University at 3 sites 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 5 inclusion and 5 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
recording signs and symptoms through clinical examination (time frame: one year follow-up). 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 3 Feb 2023.