Reversible PulpitisPhase 3NCT04167943
Conservative Pulp Therapy of Primary Molars Using TheraCAL
A Phase 3 study testing Dual cured resin modified tricalcium silicate cement in people with Reversible Pulpitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT). Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- Dual cured resin modified tricalcium silicate cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2019to 1 Sep 2021
- Phase
- Phase 3
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Four to six years old healthy children
- Cooperative (frankle scale + and ++)
- With at least one vital and restorable primary molar with deep caries.
Who cannot join
- History of spontaneous pain, swelling, or sinus tract
- Pathological mobility
- pain on percussion
- Furcation or periapical radiolucency
- Internal or external pathological root resorption
- Widening of periodontal membrane space
- Discontinuity of lamina dura.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial
The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).
Read the detailed description
Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.
- Conditions
- Reversible Pulpitis
- Being tested
- Dual cured resin modified tricalcium silicate cement
- Keywords
- indirect pulp capping, direct pulp capping, partial pulpotomy, pulpotomy, TheraCal, primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual cured resin modified tricalcium silicate cementDrug
Also called TheraCal PT
A resin based, dual cured tricalcium silicate based cement
| Study group | Role | What they receive |
|---|---|---|
| indirect pulp capping | Experimental | TheraCAL PT will be applied to affected dentin covering the pup. Receives: Drug: Dual cured resin modified tricalcium silicate cement |
| Direct pulp Capping | Experimental | TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin. Receives: Drug: Dual cured resin modified tricalcium silicate cement |
| Partial Pulpotomy | Experimental | Pulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis. Receives: Drug: Dual cured resin modified tricalcium silicate cement |
| pulpotomy | Experimental | complete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis. Receives: Drug: Dual cured resin modified tricalcium silicate cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visual and tactile clinical examination
Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis
Measured: every 6 months
Secondary outcomes (1)
Change in Dental Periapical Radiographic examination
Teeth will be examined for any radiographic signs of pulp necrosis
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start25 Nov 2019
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reversible PulpitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 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
- Investigators
- Mariem Wassel, Study director, Faculty of Dentistry, Ain Sham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167943
- Sponsor's protocol ID
- FDASU-REC R 091902
- Status last verified
- Jun 2022
- First submitted
- 26 Oct 2019
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.
PubMed 36890738
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial
- ClinicalTrials.gov ID
- NCT04167943
- Acronym / sponsor ID
- FDASU-REC R 091902
- Conditions
- Reversible Pulpitis
- Keywords
- indirect pulp capping, direct pulp capping, partial pulpotomy, pulpotomy, TheraCal, primary molars
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 19 Nov 2019 (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.
The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).
Detailed description
Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| indirect pulp capping | Experimental | Drug: Dual cured resin modified tricalcium silicate cementTheraCAL PT will be applied to affected dentin covering the pup. |
| Direct pulp Capping | Experimental | Drug: Dual cured resin modified tricalcium silicate cementTheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin. |
| Partial Pulpotomy | Experimental | Drug: Dual cured resin modified tricalcium silicate cementPulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis. |
| pulpotomy | Experimental | Drug: Dual cured resin modified tricalcium silicate cementcomplete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Four to six years old healthy children
- Cooperative (frankle scale + and ++)
- With at least one vital and restorable primary molar with deep caries.
Key exclusion criteria (7 listed)
- History of spontaneous pain, swelling, or sinus tract
- Pathological mobility
- pain on percussion
- Furcation or periapical radiolucency
- Internal or external pathological 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 |
|---|---|---|
| Dual cured resin modified tricalcium silicate cementAlso: TheraCal PTA resin based, dual cured tricalcium silicate based cement | Drug | Direct pulp Capping, Partial Pulpotomy, indirect pulp capping, pulpotomy |
Primary outcome
Changes in Visual and tactile clinical examination
Time frame: every 6 months
Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis
1 secondary outcome
Change in Dental Periapical Radiographic examination
Time frame: every 6 months
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 14 Jun 2022.
- Derived from this study: PubMed 36890738Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.
- Individual participant dataSharing planned: No
Related trials for Reversible Pulpitis
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
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Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
Pulpitis - Reversible, Pulpotomies on Primary Molars
Active, not recruiting
Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
Recruiting
Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .
Reversible Pulpitis, Deep Caries
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.
Mariem Wassel study director
Faculty of Dentistry, Ain Sham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dual cured resin modified tricalcium silicate cement in people with Reversible Pulpitis, 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 3 inclusion and 7 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 14 Jun 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Changes in Visual and tactile clinical examination (time frame: every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167943, which also lists 1 linked publication.
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 14 Jun 2022.