Pulp Inflammatory Markers and Outcome of Pulpotomy

NCT06960603 | Enrolling By Invitation DMC

• 1 other identifier: 462/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective clinical study that aims to investigate the level of inflammatory mediators in the inflamed dental pulp and its potential relationship to the outcome of full pulpotomy in mature permanent teeth with carious pulp exposure. Pulp blood samples from the teeth will be collected during treatment, MMP9 levels will be recorded using Elisa kits. The teeth will be restored and followed up at 1 week, 6 months, 1, and 2 years. The teeth will be assesses both clinically and radiographically. The procedure will be success if the tooth is asymptomatic clinically and with normal periapical findings. The relationship between MMP9 level and success of treatment will be investigated.

Conditions

Pulpitis in Permanent Teeth; Dental Caries Extending to Pulp

Keywords

Permanent teeth; Deep caries; Reversible pulpitis; Irrevrsible pulpitis; Pulpotomy; Inflammatory mediators

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Pain levels after the procedure will be assessed on a scale from 0-10, at 1 week, 6 months an 12 months postoperatively. The procedure will be considered success if the tooth is symptom free and pain levels range form 0-3. It will be considered as a failure If pain levels are \>0-3

  1 week, 6 months , 12 months

Secondary Outcomes (1)

• Radiographic Findings

  6, 12, 24 months

Study Arms (1)

Full pulpotomy using calcium silicate based material for teeth with carious pulp exposure

EXPERIMENTAL

The tooth with carious pulp exposure will be treated with full pulpotomy, Blood samples will be collected from the tooth for investigation of inflammatory mediator level. Calcium silicate based material will be placed over the pulp and the tooth will restored with resin composite. Patients symptoms will be monitored at 1 week postoperatively, the patient will score their pain levels on a scale from 0-10. The patients will be recalled at 6 and 12 months post procedure. The tooth will be examined for symptoms of pain, and radiographs will be taken. based on the findings it will be scored as success or failure of the pro cedure. this result will be corelated with the level of measure inflammatory mediators that were taken during the procedure.

Other: Full pulpotomy

Interventions

Full pulpotomy OTHER

First: Cutting the coronal pulp tissue to the level of the root canal orifices. Second: Followed by taking samples of the pulpal blood Third: Placement of calcium silicate material capping over the pulp

Also known as: Cervical pulpotomy

Full pulpotomy using calcium silicate based material for teeth with carious pulp exposure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non -contributory medical history (ASA 1)
• Molar tooth with deep caries extending\>= 2/3 of dentine or exposing the pulp on the radiograph
• The tooth should give positive response to cold sensibility testing
• Clinical diagnosis of either reversible or irreversible pulpitis based on the symptoms and results of cold testing.
• The tooth is restorable, probing pocket depth and mobility are within normal limits

You may not qualify if:

• Non-restorable tooth.
• Signs of pulpal necrosis including sinus tract or swelling.
• No enough bleeding after the pulpotomy procedure.
• Inability to achieve hemostasis within 10 min after the pulpotomy.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan university of science and Technology

Irbid, 22110, Jordan

Location

Related Publications (3)

• Sharma R, Kumar V, Logani A, Chawla A, Mir RA, Sharma S, Kalaivani M. Association between concentration of active MMP-9 in pulpal blood and pulpotomy outcome in permanent mature teeth with irreversible pulpitis - a preliminary study. Int Endod J. 2021 Apr;54(4):479-489. doi: 10.1111/iej.13437. Epub 2020 Dec 13.

  PMID: 33128238 BACKGROUND

• Taha NA, About I, Sedgley CM et al. Conservative management of mature permanent teeth with carious pulp exposure. J Endod 2020; 46: S33-S4. Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod 2022; 48: 87-95. Taha NA, Al-Rawash MH, IMRAN ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J 2022; 55:416-29.

  BACKGROUND

• AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.

  PMID: 34352305 BACKGROUND

Study Officials

• Nessrin A Taha

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Permanent teeth with deep caries reaching the dental pulp and requires full pulpotomy treatment

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 7, 2025
• Study Start: October 7, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

JO (1)