Irreversible PulpitisNCT07066410
Evaluation of Two Different Calcium Silicate Cements as a Treatment for Irreversible Pulpitis in Mature Molars
A study testing intervention 1: endocem and Intervention 1: biodentine in people with Irreversible Pulpitis, run by British University In Egypt at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of two calcium silicate cements-Biodentine and EndoCem-on post-operative pain and treatment success in vital pulp therapy (VPT) for mature permanent mandibular molars diagnosed with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- intervention 1: endocem and Intervention 1: biodentine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Patient's age ranges from 12-40 years old.
- Two Rooted Mandibular Molar teeth diagnosed with symptomatic irreversible pulpitis
- The teeth are restorable
- Informed consent granted
- Teeth are periodontally free, with no mobility and negative to percussion and palpation test.
Who cannot join
- Teeth with immature roots
- Non restorable teeth
- Bleeding could not be controlled after pulpotomy in 10 minutes
- Medically compromised patients with systemic complication that would alter the treatment.
- Necrotic teeth
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dental Clinic at the British University in Egypt Hospital
Cairo, Cairo Governorate
About this study
Official title: Evaluation of the Effect of Different Calcium Silicate Cements on the Success of Vital Pulp Therapy in Irreversible Pulpal Infection Cases With Mature Roots: A Randomized Clinical Trial
This randomized controlled clinical trial aims to evaluate the effect of two calcium silicate cements-Biodentine and EndoCem-on post-operative pain and treatment success in vital pulp therapy (VPT) for mature permanent mandibular molars diagnosed with irreversible pulpitis. A total of 50 patients will be randomly assigned into two groups to receive pulpotomy using either Biodentine or EndoCem. The trial is triple-blinded, self-funded, and conducted at the Endodontic Department, Faculty of Dentistry, The British University in Egypt.
Read the detailed description
This randomized controlled clinical trial investigates the impact of Biodentine and EndoCem on post-operative pain and treatment success in vital pulp therapy (VPT) of mature permanent mandibular molars with symptomatic irreversible pulpitis.
VPT preserves the vitality of radicular pulp by removing inflamed coronal pulp tissue and capping the remaining healthy pulp with a biocompatible material. This conservative approach may maintain pulp vitality, reduce treatment time, and improve patient outcomes compared to conventional root canal treatment.
Fifty eligible patients will be randomly assigned into two groups (n=25 per group). Pulpotomy will be performed under rubber dam isolation. After caries removal and coronal pulp amputation, hemostasis will be attempted with sterile saline-soaked cotton pellets. If bleeding persists beyond 5 minutes, the tooth will be excluded. The remaining pulp tissue will be capped with either Biodentine (Group 1) or EndoCem (Group 2), followed by immediate permanent restoration with composite resin to ensure a coronal seal.
Eligibility Criteria
Inclusion Criteria:
- Patients aged 12-40 years.
- Two-rooted mandibular molars diagnosed with symptomatic irreversible pulpitis.
- Restorable teeth.
- Periodontally healthy teeth (no mobility; negative percussion and palpation).
- Ability to provide informed consent.
Exclusion Criteria:
- Teeth with immature roots.
- Non-restorable teeth.
- Uncontrolled bleeding from the pulp after pulpotomy for more than 10 minutes.
- Necrotic teeth.
- Medically compromised patients with systemic conditions affecting treatment.
- Patients unable to provide informed consent.
- Vulnerable populations (e.g., minors without guardian consent).
Outcome Measures
Primary Outcome:
- Post-operative pain assessed using a Visual Analogue Scale (VAS; range 0-10, where 0 = no pain and 10 = worst possible pain). Time points: 6, 24, 48, and 72 hours post-treatment.
Secondary Outcome:
- Treatment success evaluated clinically (absence of pain, swelling, sinus tract) and radiographically (absence of periapical pathology) at 3 and 6 months.
- Conditions
- Irreversible Pulpitis
- Being tested
- intervention 1: endocem, Intervention 1: biodentine
- Keywords
- Vital pulp therapy, Biodentine, Endocem, Irreversible pulpitis, MTA Pulpotomy, Pulpotomy in mature teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention 1: endocemBiological
EndoCem, a premixed calcium silicate-based cement (Maruchi, Korea), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, EndoCem is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of EndoCem, followed by immediate restoration with FUJI II ensure a coronal seal.
Intervention 1: biodentineBiological
Biodentine, a tricalcium silicate-based cement (Septodont, France), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, Biodentine is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of Biodentine, followed by immediate restoration with FUJI II to ensure a coronal seal.
| Study group | Role | What they receive |
|---|---|---|
| arm 1 Endocem group | Experimental | Biological/Vaccine:
Patients will undergo pulpotomy using EndoCem (Maruchi, Korea) after achieving hemostasis. Same standardized clinical procedure as the Biodentine group, but with EndoCem material used for pulp capping and final restoration placement. Receives: Biological: intervention 1: endocem |
| arm 2: Biodentine | Active comparator | Patients will undergo pulpotomy using Biodentine (Septodont, France) after achieving hemostasis. Standardized clinical procedure including anesthesia, rubber dam isolation, access cavity preparation, coronal pulp removal, and placement of Biodentine followed Receives: Biological: Intervention 1: biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain intensity measured using the Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain
Measured: Time Frame: at 6 hours, 24 hours, 48 hours, and 72 hours after treatment
Secondary outcomes (1)
Success Rate
Teeth will be evaluated clinically for any signs or symptoms of pathosis including pain swelling sinus tract formation mobility and probing depth. teeth will be radiographically evaluated under optimum conditions, searching for periradicular pathosis, root resorption or internal resorption.Case will be considered successful if no clinical signs or symptoms and no radiographic sign of pathosis.
Measured: follow up at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Oct 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmin, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066410
- Sponsor's protocol ID
- 23-047
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Calcium Silicate Cements on the Success of Vital Pulp Therapy in Irreversible Pulpal Infection Cases With Mature Roots: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07066410
- Acronym / sponsor ID
- 23-047
- Conditions
- Irreversible Pulpitis
- Keywords
- Vital pulp therapy, Biodentine, Endocem, Irreversible pulpitis, MTA Pulpotomy, Pulpotomy in mature teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Jul 2025 (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 randomized controlled clinical trial aims to evaluate the effect of two calcium silicate cements-Biodentine and EndoCem-on post-operative pain and treatment success in vital pulp therapy (VPT) for mature permanent mandibular molars diagnosed with irreversible pulpitis. A total of 50 patients will be randomly assigned into two groups to receive pulpotomy using either Biodentine or EndoCem. The trial is triple-blinded, self-funded, and conducted at the Endodontic Department, Faculty of Dentistry, The British University in Egypt.
Detailed description
This randomized controlled clinical trial investigates the impact of Biodentine and EndoCem on post-operative pain and treatment success in vital pulp therapy (VPT) of mature permanent mandibular molars with symptomatic irreversible pulpitis.
VPT preserves the vitality of radicular pulp by removing inflamed coronal pulp tissue and capping the remaining healthy pulp with a biocompatible material. This conservative approach may maintain pulp vitality, reduce treatment time, and improve patient outcomes compared to conventional root canal treatment.
Fifty eligible patients will be randomly assigned into two groups (n=25 per group). Pulpotomy will be performed under rubber dam isolation. After caries removal and coronal pulp amputation, hemostasis will be attempted with sterile saline-soaked cotton pellets. If bleeding persists beyond 5 minutes, the tooth will be excluded. The remaining pulp tissue will be capped with either Biodentine (Group 1) or EndoCem (Group 2), followed by immediate permanent restoration with composite resin to ensure a coronal seal.
Eligibility Criteria
Inclusion Criteria:
- Patients aged 12-40 years.
- Two-rooted mandibular molars diagnosed with symptomatic irreversible pulpitis.
- Restorable teeth.
- Periodontally healthy teeth (no mobility; negative percussion and palpation).
- Ability to provide informed consent.
Exclusion Criteria:
- Teeth with immature roots.
- Non-restorable teeth.
- Uncontrolled bleeding from the pulp after pulpotomy for more than 10 minutes.
- Necrotic teeth.
- Medically compromised patients with systemic conditions affecting treatment.
- Patients unable to provide informed consent.
- Vulnerable populations (e.g., minors without guardian consent).
Outcome Measures
Primary Outcome:
- Post-operative pain assessed using a Visual Analogue Scale (VAS; range 0-10, where 0 = no pain and 10 = worst possible pain). Time points: 6, 24, 48, and 72 hours post-treatment.
Secondary Outcome:
- Treatment success evaluated clinically (absence of pain, swelling, sinus tract) and radiographically (absence of periapical pathology) at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1 Endocem group | Experimental | Biological: intervention 1: endocemBiological/Vaccine: Patients will undergo pulpotomy using EndoCem (Maruchi, Korea) after achieving hemostasis. Same standardized clinical procedure as the Biodentine group, but with EndoCem material used for pulp capping and final restoration placement. |
| arm 2: Biodentine | Active comparator | Biological: Intervention 1: biodentinePatients will undergo pulpotomy using Biodentine (Septodont, France) after achieving hemostasis. Standardized clinical procedure including anesthesia, rubber dam isolation, access cavity preparation, coronal pulp removal, and placement of Biodentine followed |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- • Patient's age ranges from 12-40 years old.
Key exclusion criteria (6 listed)
- Teeth with immature roots
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 |
|---|---|---|
| intervention 1: endocemEndoCem, a premixed calcium silicate-based cement (Maruchi, Korea), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, EndoCem is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of EndoCem, followed by immediate restoration with FUJI II ensure a coronal seal. | Biological | arm 1 Endocem group |
| Intervention 1: biodentineBiodentine, a tricalcium silicate-based cement (Septodont, France), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, Biodentine is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of Biodentine, followed by immediate restoration with FUJI II to ensure a coronal seal. | Biological | arm 2: Biodentine |
Primary outcome
Postoperative pain
Time frame: Time Frame: at 6 hours, 24 hours, 48 hours, and 72 hours after treatment
Pain intensity measured using the Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain
1 secondary outcome
Success Rate
Time frame: follow up at 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
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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 intervention 1: endocem and Intervention 1: biodentine in people with Irreversible Pulpitis, run by British University In Egypt 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 5 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative pain (time frame: Time Frame: at 6 hours, 24 hours, 48 hours, and 72 hours after treatment). 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 22 Jul 2025.