Clinical trial NCT04933955: Evaluation of Post Operative Pain and Success Rate After Pulpotomy
Official title: Comparative Evaluation of Post Operative Pain and Success Rate After Pulpotomy Using Different Tricalcium Silicate Based Materials (A Randomized Clinical Trial )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Root Canal Infection
Keywords: pulpotomy
Tricalcium silicate
Biodentine
vital pulp therapy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: post operative pain
timeFrame: pre-operative
measure: post operative pain
timeFrame: 6 hours following the end of the procedure.
measure: post operative pain
timeFrame: 12 hours following the end of the procedure.
measure: post operative pain
timeFrame: 24 hours following the end of the procedure.
measure: post operative pain
timeFrame: 48 hours following the end of the procedure.
measure: post operative pain
timeFrame: 72 hours following the end of the procedure.
Secondary outcomes:
measure: Pulpotomy success
timeFrame: 3 months after the intervention
measure: Pulpotomy success
timeFrame: 6 months after the intervention
measure: Pulpotomy success
timeFrame: 9 months after the intervention
measure: Pulpotomy success
timeFrame: 12 months after the intervention
measure: Pulpotomy success
timeFrame: 18 months after the intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Ahmed Abdel Rahman Hashem, phd
role: STUDY_DIRECTOR
References:
citation: 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.