Evaluation of Post Operative Pain and Success Rate After Pulpotomy

Root Canal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933955
• Other study ID #: 7/6/21
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2021
• Source: Ain Shams University
• Contact: Ahmed Abdel Rahman m Hashem, phd
• Phone: 226401884
• Email: ahmed[@]endohashem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Root Canal Infection

Intervention

Procedure:
• vital pulp therapy
pulpotomy

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post operative pain	Each patient will be asked to fill the visual analogue scale to rate the pain level	pre-operative
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Pulpotomy success	clinical and radiographic absence of inflammation	3 months after the intervention
Secondary	Pulpotomy success	clinical and radiographic absence of inflammation	6 months after the intervention
Secondary	Pulpotomy success	clinical and radiographic absence of inflammation	9 months after the intervention
Secondary	Pulpotomy success	clinical and radiographic absence of inflammation	12 months after the intervention
Secondary	Pulpotomy success	clinical and radiographic absence of inflammation	18 months after the intervention