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 )

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04933955

Enrollment

Registered

2021-06-22

Start date

2021-06-01

Completion date

2022-12-01

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Canal Infection

Keywords

pulpotomy, Tricalcium silicate, Biodentine, vital pulp therapy

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

Interventions

PROCEDUREvital pulp therapy

pulpotomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
post operative pain	pre-operative	Each patient will be asked to fill the visual analogue scale to rate the pain level

Secondary

Measure	Time frame	Description
Pulpotomy success	3 months after the intervention	clinical and radiographic absence of inflammation

Countries

Egypt

Contacts

Primary ContactAhmed Abdel Rahman m Hashem, phd

ahmed@endohashem.com226401884

Backup ContactAhmed Abdel Rahman Hashem, phd