An interventional study of VPT Group and RCT Group in Pulpitis - Irreversible, Pulpitis and Pulpotomy, sponsored by Universidad Central de Venezuela. Completed at 1 site in Venezuela. Open to participants aged 26 Years to 61 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Universidad Central de Venezuela · Not applicable, Interventional, and Other
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.
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
This study's enrollment of 43 is below the median of 64 across 288 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Universidad Central de Venezuela is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
Time frame: 12 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Time frame: The data will be available starting 6 months and up to 1 year following article publication
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Central de Venezuela