Pulpitis - IrreversibleNCT07355140
Vital Pulp Therapy vs. Root Canal Treatment in Mature Teeth With Irreversible Pulpitis
A study testing VPT Group and RCT Group in people with Pulpitis - Irreversible and Pulpitis, run by Universidad Central de Venezuela at 1 site in Venezuela.
Trial summary
This study was designed as a prospective, randomized, controlled clinical trial with parallel groups and double blinding, following the principles of the Declaration of Helsinki for human experimentation and in accordance with CONSORT guidelines. Read more about this study
- Who is it for?
- Ages 26 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible, Pulpitis, Pulpotomy
- What is being tested?
- VPT Group and RCT Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteVenezuela
- Study dates
- 1 Jan 2021to 30 Nov 2023
- Phase
- Interventional
- 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 26 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Posterior teeth with closed apices.
- Deep carious lesions radiographically close to the pulp.
- Symptoms of symptomatic irreversible pulpitis (spontaneous and/or sharp pain, localized or referred, provoked and persistent to thermal stimuli).
- Teeth restored with direct restorations.
Who cannot join
- Subgingival caries or restorations.
- Moderate or severe periodontitis.
- Internal or external resorption.
- Calcification of the pulp chamber or root canals.
- Uncontrolled pulpal bleeding within 15 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Vital Pulp Therapy and Root Canal Treatment in Mature Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
This study was designed as a prospective, randomized, controlled clinical trial with parallel groups and double blinding, following the principles of the Declaration of Helsinki for human experimentation and in accordance with CONSORT guidelines. The study protocol was approved by the Bioethics Committee of the Faculty of Dentistry, Central University of Venezuela
Forty-six patients were enrolled and evenly assigned to two groups (VPT group: Vital Pulp Therapy Group; RCT Group: Root canal treatment group); 43 completed the 12-month follow-up (22 in the VPT group and 20 in the RCT group).
Read more
Patients were assigned to the experimental group (VPT) or control group (RCT) using a block randomization method (block size = 4). The randomization sequence was kept in sealed envelopes and revealed by a team member not involved in the study.
Clinical Procedures:
Preoperative periapical radiographs were taken using the parallel cone technique for both groups, and bitewing radiographs were additionally obtained for the experimental group. All procedures were performed under local anesthesia with 3% mepivacaine (inferior alveolar nerve block for mandibular teeth and infiltration for maxillary teeth) and rubber dam isolation.
- Experimental Group (VPT): A 10 mL blood sample was collected to obtain PRF following Choukroun's protocol. Caries removal was performed non-selectively using sterile carbide burs at high speed with water cooling. After pulp exposure, passive irrigation with 5.25% NaOCl was performed. Inflamed pulp tissue was gradually removed under magnification using a fine-grit diamond bur until vascular, slightly bleeding tissue was observed. Hemostasis was achieved by gentle pressure with a sterile dry cotton pellet; if bleeding persisted, additional tissue removal was performed for up to 15 minutes. In some cases, full pulpotomy was required. PRF was compressed and trimmed to cover the exposed pulp tissue, then sealed with 2-3 mm of EndoSequence BC putty. The cavity was restored with self-curing glass ionomer and definitive composite resin.
- Control Group (RCT): After caries removal, access cavity preparation was performed, and working length was determined using an electronic apex locator (Root ZX; J Morita, Irvine, CA). Root canals were instrumented with nickel-titanium rotary files (.04 taper) up to three sizes beyond the first file, with resistance. Irrigation was performed with 5.25% NaOCl and 17% EDTA. Obturation was completed using lateral compaction with gutta-percha and AH Plus sealer. The access cavity was sealed with glass ionomer and restored with composite resin.
- Conditions
- Pulpitis - Irreversible, Pulpitis, Pulpotomy, Root Canal Therapy
- Being tested
- VPT Group and RCT Group
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPT Group and RCT GroupProcedure or surgery
In the VPT group, partial or complete pulpotomy was performed using PRF, followed by a bioceramic covering and definitive restoration. In the RCT group, root canal treatment was performed, and the coronal access was definitively sealed.
| Study group | Role | What they receive |
|---|---|---|
| Vital Pulp Therapy Group (VPT Group) | Experimental | A 10 mL blood sample was collected to obtain PRF following Choukroun's protocol. Caries removal was performed non-selectively using sterile carbide burs at high speed with water cooling. After pulp exposure, passive irrigation with 5.25% NaOCl was performed. Inflamed pulp tissue was gradually removed under magnification using a fine-grit diamond bur until vascular, slightly bleeding tissue was observed. Hemostasis was achieved by gentle pressure with a sterile dry cotton pellet; if bleeding persisted, additional tissue removal was performed for up to 15 minutes. In some cases, full pulpotomy was required. PRF was compressed and trimmed to cover the exposed pulp tissue, then sealed with 2-3 mm of EndoSequence BC putty. The cavity was restored with self-curing glass ionomer and definitive composite resin. Receives: Procedure: VPT Group and RCT Group |
| Root Canal Treatment Group (RCT Group) | Active comparator | After caries removal, access cavity preparation was performed, and working length was determined using an electronic apex locator (Root ZX; J Morita, Irvine, CA). Root canals were instrumented with nickel-titanium rotary files (.04 taper) up to three sizes beyond the first file, with resistance. Irrigation was performed with 5.25% NaOCl and 17% EDTA. Obturation was completed using lateral compaction with gutta-percha and AH Plus sealer. The access cavity was sealed with glass ionomer and restored with composite resin. Receives: Procedure: VPT Group and RCT Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Teeth Categorized as Clinical and Radiographic Success
Success is a composite measure defined by the following criteria:
Clinical Success: Absence of spontaneous pain (excluding the immediate postoperative period), tooth is functional and asymptomatic, with no sensitivity to percussion or palpation, and normal soft tissues.
Radiographic Success: Absence of periapical pathology, such as new periapical radiolucency or root resorption.
A case is considered a "Success" only when both clinical and radiographic criteria are met. Results will be reported as the percentage of teeth that meet these success criteria.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jan 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, controlled, parallel-group, double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Central de Venezuela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Norberto Goncalves Pereira, Universidad Central de Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355140
- Sponsor's protocol ID
- UCVenezuela
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Vital Pulp Therapy and Root Canal Treatment in Mature Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07355140
- Acronym / sponsor ID
- UCVenezuela
- Conditions
- Pulpitis - Irreversible, Pulpitis, Pulpotomy, Root Canal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universidad Central de VenezuelaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Jan 2026 (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 was designed as a prospective, randomized, controlled clinical trial with parallel groups and double blinding, following the principles of the Declaration of Helsinki for human experimentation and in accordance with CONSORT guidelines. The study protocol was approved by the Bioethics Committee of the Faculty of Dentistry, Central University of Venezuela
Forty-six patients were enrolled and evenly assigned to two groups (VPT group: Vital Pulp Therapy Group; RCT Group: Root canal treatment group); 43 completed the 12-month follow-up (22 in the VPT group and 20 in the RCT group).
Patients were assigned to the experimental group (VPT) or control group (RCT) using a block randomization method (block size = 4). The randomization sequence was kept in sealed envelopes and revealed by a team member not involved in the study.
Clinical Procedures:
Preoperative periapical radiographs were taken using the parallel cone technique for both groups, and bitewing radiographs were additionally obtained for the experimental group. All procedures were performed under local anesthesia with 3% mepivacaine (inferior alveolar nerve block for mandibular teeth and infiltration for maxillary teeth) and rubber dam isolation.
- Experimental Group (VPT): A 10 mL blood sample was collected to obtain PRF following Choukroun's protocol. Caries removal was performed non-selectively using sterile carbide burs at high speed with water cooling. After pulp exposure, passive irrigation with 5.25% NaOCl was performed. Inflamed pulp tissue was gradually removed under magnification using a fine-grit diamond bur until vascular, slightly bleeding tissue was observed. Hemostasis was achieved by gentle pressure with a sterile dry cotton pellet; if bleeding persisted, additional tissue removal was performed for up to 15 minutes. In some cases, full pulpotomy was required. PRF was compressed and trimmed to cover the exposed pulp tissue, then sealed with 2-3 mm of EndoSequence BC putty. The cavity was restored with self-curing glass ionomer and definitive composite resin.
- Control Group (RCT): After caries removal, access cavity preparation was performed, and working length was determined using an electronic apex locator (Root ZX; J Morita, Irvine, CA). Root canals were instrumented with nickel-titanium rotary files (.04 taper) up to three sizes beyond the first file, with resistance. Irrigation was performed with 5.25% NaOCl and 17% EDTA. Obturation was completed using lateral compaction with gutta-percha and AH Plus sealer. The access cavity was sealed with glass ionomer and restored with composite resin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective, randomized, controlled, parallel-group, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Vital Pulp Therapy Group (VPT Group) | Experimental | Procedure: VPT Group and RCT GroupA 10 mL blood sample was collected to obtain PRF following Choukroun's protocol. Caries removal was performed non-selectively using sterile carbide burs at high speed with water cooling. After pulp exposure, passive irrigation with 5.25% NaOCl was performed. Inflamed pulp tissue was gradually removed under magnification using a fine-grit diamond bur until vascular, slightly bleeding tissue was observed. Hemostasis was achieved by gentle pressure with a sterile dry cotton pellet; if bleeding persisted, additional tissue removal was performed for up to 15 minutes. In some cases, full pulpotomy was required. PRF was compressed and trimmed to cover the exposed pulp tissue, then sealed with 2-3 mm of EndoSequence BC putty. The cavity was restored with self-curing glass ionomer and definitive composite resin. |
| Root Canal Treatment Group (RCT Group) | Active comparator | Procedure: VPT Group and RCT GroupAfter caries removal, access cavity preparation was performed, and working length was determined using an electronic apex locator (Root ZX; J Morita, Irvine, CA). Root canals were instrumented with nickel-titanium rotary files (.04 taper) up to three sizes beyond the first file, with resistance. Irrigation was performed with 5.25% NaOCl and 17% EDTA. Obturation was completed using lateral compaction with gutta-percha and AH Plus sealer. The access cavity was sealed with glass ionomer and restored with composite resin. |
Who may qualify
- Ages
- 26 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Posterior teeth with closed apices.
- Deep carious lesions radiographically close to the pulp.
- Symptoms of symptomatic irreversible pulpitis (spontaneous and/or sharp pain, localized or referred, provoked and persistent to thermal stimuli).
- Teeth restored with direct restorations.
Key exclusion criteria (5 listed)
- Subgingival caries or restorations.
- Moderate or severe periodontitis.
- Internal or external resorption.
- Calcification of the pulp chamber or root canals.
- Uncontrolled pulpal bleeding within 15 minutes.
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 |
|---|---|---|
| VPT Group and RCT GroupIn the VPT group, partial or complete pulpotomy was performed using PRF, followed by a bioceramic covering and definitive restoration. In the RCT group, root canal treatment was performed, and the coronal access was definitively sealed. | Procedure or surgery | Root Canal Treatment Group (RCT Group), Vital Pulp Therapy Group (VPT Group) |
Primary outcome
Percentage of Teeth Categorized as Clinical and Radiographic Success
Time frame: 12 months
Success is a composite measure defined by the following criteria: Clinical Success: Absence of spontaneous pain (excluding the immediate postoperative period), tooth is functional and asymptomatic, with no sensitivity to percussion or palpation, and normal soft tissues. Radiographic Success: Absence of periapical pathology, such as new periapical radiolucency or root resorption. A case is considered a "Success" only when both clinical and radiographic criteria are met. Results will be reported as the percentage of teeth that meet these success criteria.
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 21 Jan 2026.
- Individual participant dataSharing planned: Yes
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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 VPT Group and RCT Group in people with Pulpitis - Irreversible and Pulpitis, run by Universidad Central de Venezuela at 1 site in Venezuela.
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 4 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 21 Jan 2026. 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 Venezuela. 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?
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?
Percentage of Teeth Categorized as Clinical and Radiographic Success (time frame: 12 months). 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 21 Jan 2026.