Vital Pulp Therapy vs. Root Canal Treatment in Mature Teeth With Irreversible Pulpitis

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).

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 Overview

• Status: Completed
• Conditions: Pulpitis; Root Canal Therapy; Pulpitis - Irreversible; Pulpotomy
• Intervention / Treatment: Procedure: VPT Group and RCT Group

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Venezuela
  • DC
    • Caracas, DC, Venezuela, 1050
      • Central University of Venezuela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vital Pulp Therapy Group (VPT Group); 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.	Procedure: VPT Group and RCT Group; 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.
Active Comparator: Root Canal Treatment Group (RCT Group); 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.	Procedure: VPT Group and RCT Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Universidad Central de Venezuela

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis
• Other Study ID Numbers: UCVenezuela

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data will be available starting 6 months and up to 1 year following article publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No