Pulp CapingPhase 4NCT06020911
Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars
A Phase 4 study testing Biodentine and Theracal light cured in people with Pulp Caping and Biodentine, run by Tanta University at 1 site in Egypt.
Trial summary
this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pulp Caping, Biodentine, Theracal
- What is being tested?
- Biodentine and Theracal light cured
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2023to 1 Oct 2023
- 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
- No healthy volunteers
- Child
Who may be able to join
- Each child has bilateral vital cavitated carious lesions in primary molars.
- Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.
- Patient and parent cooperation.
- Accessible isolation for the operated tooth with rubber dam.
- primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
- Availability of remaining dentin thickness over the pulp.
- Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.
Who cannot join
- Spontaneous pain, or persistent swelling or fistula.
- Pain with percussion, presence of abscess and pathological mobility.
- Uncooperative patient.
- Progression of caries lesion to pulp and pulp exposure.
- Presence of periapical lesion as abscess, cyst or granuloma.
- Unhealthy bony tissues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars
this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping
Read the detailed description
Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp capping material is to be successful when it is biocompatible, radiopaque, maintain good seal, protect the pulp against bacterial invasion in both long and short run, release sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate reparative dentin formation through inducing the pulp cells to form odontoblasts.
Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine
- Conditions
- Pulp Caping, Biodentine, Theracal
- Being tested
- Biodentine, Theracal light cured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
17 primary second molars of 17 children will be capped with Biodentine
Theracal light curedDrug
17 primary second molars of 17 children will be capped with Theracal light cured
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Active comparator | 17 primary second molars of 17 children will be capped with Biodentine. Receives: Drug: Biodentine |
| Theracal light cured | Active comparator | 17 primary second molars of 17 children will be capped with Theracal light cured Receives: Drug: Theracal light cured |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of dentin in mm
Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm
Measured: UP to 9 months postoperatively
Radiodenisty in Hounsfield units
Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units
Measured: UP to 9 months postoperatively
pulp vitality
The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact
Measured: UP to 9 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start30 Jan 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp CapingStudies 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
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abd Elhameed Abd Elghany, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020911
- Sponsor's protocol ID
- R-PED-6-21-6
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars
- ClinicalTrials.gov ID
- NCT06020911
- Acronym / sponsor ID
- R-PED-6-21-6
- Conditions
- Pulp Caping, Biodentine, Theracal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 1 Sep 2023 (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.
this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping
Detailed description
Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp capping material is to be successful when it is biocompatible, radiopaque, maintain good seal, protect the pulp against bacterial invasion in both long and short run, release sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate reparative dentin formation through inducing the pulp cells to form odontoblasts.
Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Active comparator | Drug: Biodentine17 primary second molars of 17 children will be capped with Biodentine. |
| Theracal light cured | Active comparator | Drug: Theracal light cured17 primary second molars of 17 children will be capped with Theracal light cured |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Each child has bilateral vital cavitated carious lesions in primary molars.
- Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.
- Patient and parent cooperation.
- Accessible isolation for the operated tooth with rubber dam.
- primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
Key exclusion criteria (6 listed)
- Spontaneous pain, or persistent swelling or fistula.
- Pain with percussion, presence of abscess and pathological mobility.
- Uncooperative patient.
- Progression of caries lesion to pulp and pulp exposure.
- Presence of periapical lesion as abscess, cyst or granuloma.
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 |
|---|---|---|
| Biodentine17 primary second molars of 17 children will be capped with Biodentine | Drug | Biodentine |
| Theracal light cured17 primary second molars of 17 children will be capped with Theracal light cured | Drug | Theracal light cured |
Primary outcome
Thickness of dentin in mm
Time frame: UP to 9 months postoperatively
Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm
Radiodenisty in Hounsfield units
Time frame: UP to 9 months postoperatively
Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units
pulp vitality
Time frame: UP to 9 months postoperatively
The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact
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 1 May 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Pulp Caping
Recruiting
Clinical and Radiographic Evaluation of Dia-Root Bio MTA for Indirect Pulp Capping in Young Permanent Molars
MTA, Pulp Caping
Active, not recruitingObservational study
The Effect of Genetic Polymorphisms on the Success of Vital Pulp Therapy
Pulp Exposure, Dental, Pulp Disease, Dental
Not yet recruitingPhase 2
Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Platelet Rich Fibrin Versus Mineral Trioxide Aggregate in Deep Carious Molars: a Randomized Controlled Trial
Dental Caries, Pulp Caping
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 Biodentine and Theracal light cured in people with Pulp Caping and Biodentine, run by Tanta 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 7 inclusion and 6 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 1 May 2024. 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?
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?
Thickness of dentin in mm (time frame: UP to 9 months postoperatively). The study lists 3 primary outcomes in all. 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 1 May 2024.