Vital Pulp TherapiesPhase 3VPTNCT06787742
Assessment of the Number of Missing Tooth Surfaces and the Molecular Findings on the Outcomes of Vital Pulp Therapy Using Two Calcium Silicate Materials
A Phase 3 study testing full pulpotomy in people with Vital Pulp Therapies and Tooth Defect, run by Suez Canal University at 1 site in Egypt.
Trial summary
The present study aimed to evaluate and compare the clinical and radiographic outcomes of full pulpotomy in mandibular molar teeth with symptomatic irreversible pulpitis according to: A. Number of tooth surfaces defects: Class I cavity defect. Class II cavity defect. B. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Vital Pulp Therapies, Tooth Defect
- What is being tested?
- full pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2022to 1 May 2024
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mandibular molar teeth with signs and symptoms of symptomatic irreversible pulpitis without radiographic evidence of apical periodontitis.
- Age range of 21-45 years old.
- Males or females.
- No disabilities.
- Class I and/or class II cavity defects.
- Teeth reveal positive response to cold tests.
Who cannot join
- Presence of open apices.
- Non-restorable teeth.
- Teeth in which the pulpal bleeding time is more than 10 minutes.
- Presence of large carious lesions approaching the root.
- Presence of calcification or resorption.
- Periodontally affected teeth.
Show all 10Show fewer
- Patients who are taking antibiotics within one week before treatment.
- Patients consumed taking analgesics within 24 hours before treatment.
- Systemically compromised patients.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Number of Missing Tooth Surfaces and a New Bioceramic Material on the Outcomes of Vital Pulp Therapy: A Randomized Clinical Study
The present study aimed to evaluate and compare the clinical and radiographic outcomes of full pulpotomy in mandibular molar teeth with symptomatic irreversible pulpitis according to:
- Number of tooth surfaces defects:
Read more
- Class I cavity defect.
- Class II cavity defect.
- Using two types of pulpotomy dressing materials:
- MTA+ (Cerkamed, Stalowa, Poland).
- Well-Root PT (Vericom, Gangwon-Do, Korea). And.,
To correlate this outcome to the quantification of two biomolecules:
- Tumor necrosis factor-alpha (TNF-⍺).
- Matrix metalloproteinases-9 (MMP-9).
Based on the results of the present study, it was concluded that:
- Full pulpotomy using calcium silicate cements (CSCs) is considered a conservative, economical, and simple treatment option with a favorable prognosis for teeth with symptomatic irreversible pulpitis.
- Class I and class II cavity defects do not adversely affect pulpotomy prognosis taking into consideration good aseptic condition, magnification, and proper seal of filling materials.
- Although MTA+ and Well-Root PT yielded similar outcomes for pulpotomy in terms of success rates. Well-root PT is easier to handle compared to MTA+ and doesn't have a discoloration effect which is considered one of the drawbacks associated with MTA+.
- Neither the preoperative pain nor the intraoperative bleeding time within 10 minutes influenced the pulpotomy outcome.
- The concentration of TNF-α and MMP-9 biomarkers directly impact the outcome of pulpotomy.
Read the detailed description
The current study addresses an important gap in research, as the impact of cavity configuration on the outcomes of full pulpotomy has not been well explored. Comparing Class I and Class II cavity defects in this context can provide valuable insights, especially given the differences in structural integrity, bacterial infiltration risks, and restorative challenges associated with these defects.
- Conditions
- Vital Pulp Therapies, Tooth Defect
- Being tested
- full pulpotomy
- Keywords
- Biomarkers, Calcium silicate cements, Full pulpotomy, Irreversible pulpitis, Mature teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full pulpotomyProcedure or surgery
Also called collecting pulpal blood samples, Hemostasis, pulpotomy dressing materials, final restoration
access to dental pulp chamber under aseptic condition, collect blood sample using a micropipette for ELIZA test, stop bleeding using sodium hypochlorite 2.5%, pulpotomy dressing material over pulp stump and final restoration with resign modified glass ionomer and composite resign
| Study group | Role | What they receive |
|---|---|---|
| A. Number of tooth surfaces defects: • Class I cavity defect. • Class II cavity defect. | Active comparator | The selected patients were divided into two groups according to the number of tooth surfaces defects (n=30) (30 with class I and 30 with class II cavity defects) Receives: Procedure: full pulpotomy |
| pulpotomy dressing materials: • MTA+ (Cerkamed, Poland). • Well-Root (Vericom, Korea). | Active comparator | Each group was randomly further subdivided using Microsoft Excel into two subgroups according to the dressing materials, without informing the patients which type of material was used (n=15). Receives: Procedure: full pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success/failure
Treatment was considered successful (healed) according to Zanini et al. (2016) based on the following criteria:
(Clinically) absence of signs and symptoms of pulpal pathosis, no history of spontaneous pain or discomfort on chewing, no tenderness to percussion/palpation, no soft tissue swelling, fistula, or abnormal mobility. (Radiographically) absence of periapical rarefaction (normal width of periodontal ligament space and normal appearance of the lamina dura), internal or external resorption, and absence of root canal calcification
Measured: Patients were scheduled for follow-up appointments (one week, 3, 6, and 12 months)
Pain assessment
Pre-treatment, the patients were instructed on how to fill out a visual analog scale VAS to determine their pain score. Postoperative pain was recorded by the patient every 24 hours in the evening for 7 days. The VAS included scores from 0 to 10, which were further categorized as no pain (0), mild (1-3), moderate (4-6), severe (7-9), or severe intolerable (10).
Measured: every 24 hours in the evening for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start21 Sep 2022
- Primary completion1 Oct 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapiesStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparative, randomized, prospective clinical study was utilized for the investigation of the outcome of pulpotomy in the treatment of adult permanent mandibular molar teeth with symptomatic irreversible pulpitis in class I and class II cavity defects using two types of hydraulic calcium silicate cement (MTA+) and (Well-root PT)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dalia Mukhtar Fayyad, Professor of endodontics, Study chair, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787742
- Sponsor's protocol ID
- (528/2022)
- Acronym
- VPT
- Status last verified
- Jun 2025
- First submitted
- 16 Jan 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Number of Missing Tooth Surfaces and a New Bioceramic Material on the Outcomes of Vital Pulp Therapy: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06787742
- Acronym / sponsor ID
- VPT / (528/2022)
- Conditions
- Vital Pulp Therapies, Tooth Defect
- Keywords
- Biomarkers, Calcium silicate cements, Full pulpotomy, Irreversible pulpitis, Mature teeth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 22 Jan 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.
The present study aimed to evaluate and compare the clinical and radiographic outcomes of full pulpotomy in mandibular molar teeth with symptomatic irreversible pulpitis according to:
- Number of tooth surfaces defects:
- Class I cavity defect.
- Class II cavity defect.
- Using two types of pulpotomy dressing materials:
- MTA+ (Cerkamed, Stalowa, Poland).
- Well-Root PT (Vericom, Gangwon-Do, Korea). And.,
To correlate this outcome to the quantification of two biomolecules:
- Tumor necrosis factor-alpha (TNF-⍺).
- Matrix metalloproteinases-9 (MMP-9).
Based on the results of the present study, it was concluded that:
- Full pulpotomy using calcium silicate cements (CSCs) is considered a conservative, economical, and simple treatment option with a favorable prognosis for teeth with symptomatic irreversible pulpitis.
- Class I and class II cavity defects do not adversely affect pulpotomy prognosis taking into consideration good aseptic condition, magnification, and proper seal of filling materials.
- Although MTA+ and Well-Root PT yielded similar outcomes for pulpotomy in terms of success rates. Well-root PT is easier to handle compared to MTA+ and doesn't have a discoloration effect which is considered one of the drawbacks associated with MTA+.
- Neither the preoperative pain nor the intraoperative bleeding time within 10 minutes influenced the pulpotomy outcome.
- The concentration of TNF-α and MMP-9 biomarkers directly impact the outcome of pulpotomy.
Detailed description
The current study addresses an important gap in research, as the impact of cavity configuration on the outcomes of full pulpotomy has not been well explored. Comparing Class I and Class II cavity defects in this context can provide valuable insights, especially given the differences in structural integrity, bacterial infiltration risks, and restorative challenges associated with these defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A comparative, randomized, prospective clinical study was utilized for the investigation of the outcome of pulpotomy in the treatment of adult permanent mandibular molar teeth with symptomatic irreversible pulpitis in class I and class II cavity defects using two types of hydraulic calcium silicate cement (MTA+) and (Well-root PT)
| Arm | Type | Receives |
|---|---|---|
| A. Number of tooth surfaces defects: • Class I cavity defect. • Class II cavity defect. | Active comparator | Procedure: full pulpotomyThe selected patients were divided into two groups according to the number of tooth surfaces defects (n=30) (30 with class I and 30 with class II cavity defects) |
| pulpotomy dressing materials: • MTA+ (Cerkamed, Poland). • Well-Root (Vericom, Korea). | Active comparator | Procedure: full pulpotomyEach group was randomly further subdivided using Microsoft Excel into two subgroups according to the dressing materials, without informing the patients which type of material was used (n=15). |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Mandibular molar teeth with signs and symptoms of symptomatic irreversible pulpitis without radiographic evidence of apical periodontitis.
- Age range of 21-45 years old.
- Males or females.
- No disabilities.
- Class I and/or class II cavity defects.
Key exclusion criteria (10 listed)
- Presence of open apices.
- Non-restorable teeth.
- Teeth in which the pulpal bleeding time is more than 10 minutes.
- Presence of large carious lesions approaching the root.
- Presence of calcification or 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 |
|---|---|---|
| full pulpotomyAlso: collecting pulpal blood samples, Hemostasis, pulpotomy dressing materials, final restorationaccess to dental pulp chamber under aseptic condition, collect blood sample using a micropipette for ELIZA test, stop bleeding using sodium hypochlorite 2.5%, pulpotomy dressing material over pulp stump and final restoration with resign modified glass ionomer and composite resign | Procedure or surgery | A. Number of tooth surfaces defects: • Class I cavity defect. • Class II cavity defect., pulpotomy dressing materials: • MTA+ (Cerkamed, Poland). • Well-Root (Vericom, Korea). |
Primary outcome
success/failure
Time frame: Patients were scheduled for follow-up appointments (one week, 3, 6, and 12 months)
Treatment was considered successful (healed) according to Zanini et al. (2016) based on the following criteria: (Clinically) absence of signs and symptoms of pulpal pathosis, no history of spontaneous pain or discomfort on chewing, no tenderness to percussion/palpation, no soft tissue swelling, fistula, or abnormal mobility. (Radiographically) absence of periapical rarefaction (normal width of periodontal ligament space and normal appearance of the lamina dura), internal or external resorption, and absence of root canal calcification
Pain assessment
Time frame: every 24 hours in the evening for 7 days
Pre-treatment, the patients were instructed on how to fill out a visual analog scale VAS to determine their pain score. Postoperative pain was recorded by the patient every 24 hours in the evening for 7 days. The VAS included scores from 0 to 10, which were further categorized as no pain (0), mild (1-3), moderate (4-6), severe (7-9), or severe intolerable (10).
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 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis
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Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
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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.
Dalia Mukhtar Fayyad, Professor of endodontics study chair
Suez Canal 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 full pulpotomy in people with Vital Pulp Therapies and Tooth Defect, run by Suez Canal 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 6 inclusion and 10 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 5 Jun 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.
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?
success/failure (time frame: Patients were scheduled for follow-up appointments (one week, 3, 6, and 12 months)). The study lists 2 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 5 Jun 2025.