Evaluation of Post Operative Pain and Success Rate After Pulpotomy

Comparative Evaluation of Post Operative Pain and Success Rate After Pulpotomy Using Different Tricalcium Silicate Based Materials (A Randomized Clinical Trial )

The aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.

Study Overview

• Status: Recruiting
• Conditions: Root Canal Infection
• Intervention / Treatment: Procedure: vital pulp therapy

Detailed Description

Setting and location :

Out-patients clinic of Endodontic Department, Faculty of Dentistry, Ain Shams University

Patient allocation:

Using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups .

The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.

Patient Classification:

Patients will be randomly divided into three groups according to material used in pulpotomy Group (1) Biodentine (n=20) Group (2) theracal PT (n=20) Group (3) Neoputty (n=20)

Procedural steps:

• Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading on a visual analogue scale (VAS)
• Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
• Rubber dam isolation of tooth
• Tooth surface disinfection using guaze soaked in 5.25% sodium hypochlorite
• Access cavity will be performed using a carbide steel round bur and tapered diamond stone until complete deroofing.
• Using a sterile excavator, the coronal pulp tissue will be excavated14
• Cotton pellets soaked in 2.5 % sodium hypochlorite will be used to achieve hemostasis for 2-3 minutes
• Once hemostasis will be achieved one of the three materials will be placed according to the manufacturer's instructions
• Final restoration will be placed

Methods of evaluation

1. Post operative pain
2. Pulpotomy success rate

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abdel Rahman m Hashem, phd; Phone Number: 226401884; Email: ahmed@endohashem.com
• Study Contact Backup: Name: Ahmed Abdel Rahman Hashem, phd; Phone Number: 226401884; Email: ahmed@endohashem.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University
    • Contact: shehabeldin m saber, prof; Phone Number: +201001413734; Email: saberse@asfd.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients age between 20 and 40 years old.

  • Teeth diagnosed with symptomatic irreversible pulpitis.
  • Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space.
  • The teeth are restorable.
  • Teeth probing depth and mobility should be within normal limits.

Exclusion Criteria:

• Teeth with immature roots

  • Non restorable teeth
  • Bleeding could not be controlled after pulpotomy in 10 minutes.
  • Medically compromised patients with systemic complication that would alter the treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: biodentine; pulptomy with biodentine	Procedure: vital pulp therapy; pulpotomy
ACTIVE_COMPARATOR: Theracal PT; pulpotomy with Theracal PT	Procedure: vital pulp therapy; pulpotomy
ACTIVE_COMPARATOR: Neo Putty; pulpotomy with Neo putty	Procedure: vital pulp therapy; pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	Each patient will be asked to fill the visual analogue scale to rate the pain level	pre-operative
post operative pain	Each patient will be asked to fill the visual analogue scale to rate the pain level	6 hours following the end of the procedure.
post operative pain	Each patient will be asked to fill the visual analogue scale to rate the pain level	12 hours following the end of the procedure.
post operative pain	Each patient will be asked to fill the visual analogue scale to rate the pain level	24 hours following the end of the procedure.
post operative pain	Each patient will be asked to fill the visual analogue scale to rate the pain level	48 hours following the end of the procedure.
post operative pain	Each patient will be asked to fill the visual analogue scale to rate the pain level	72 hours following the end of the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulpotomy success	clinical and radiographic absence of inflammation	3 months after the intervention
Pulpotomy success	clinical and radiographic absence of inflammation	6 months after the intervention
Pulpotomy success	clinical and radiographic absence of inflammation	9 months after the intervention
Pulpotomy success	clinical and radiographic absence of inflammation	12 months after the intervention
Pulpotomy success	clinical and radiographic absence of inflammation	18 months after the intervention

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ahmed Abdel Rahman Hashem, phd, Ain Shams University

Publications and helpful links

General Publications

• Haikal L, Ferraz Dos Santos B, Vu DD, Braniste M, Dabbagh B. Biodentine Pulpotomies on Permanent Traumatized Teeth with Complicated Crown Fractures. J Endod. 2020 Sep;46(9):1204-1209. doi: 10.1016/j.joen.2020.06.003. Epub 2020 Jun 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (ACTUAL): June 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pulpotomy; Biodentine; vital pulp therapy; Tricalcium silicate
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 7/6/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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