NCT04933955

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 7, 2021

Last Update Submit

June 14, 2021

Conditions

Root Canal Infection

Keywords

pulpotomyTricalcium silicateBiodentinevital pulp therapy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Pulpotomy success

    3 months after the intervention

  • Pulpotomy success

    6 months after the intervention

  • Pulpotomy success

    9 months after the intervention

  • Pulpotomy success

    12 months after the intervention

  • Pulpotomy success

    18 months after the intervention

Study Arms (3)

biodentine

ACTIVE COMPARATOR

pulptomy with biodentine

Procedure: vital pulp therapy

Theracal PT

ACTIVE COMPARATOR

pulpotomy with Theracal PT

Procedure: vital pulp therapy

Neo Putty

ACTIVE COMPARATOR

pulpotomy with Neo putty

Procedure: vital pulp therapy

Interventions

vital pulp therapyPROCEDURE

pulpotomy

Neo PuttyTheracal PTbiodentine

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Related 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.

    PMID: 32553879RESULT

Study Officials

  • Ahmed Abdel Rahman Hashem, phd

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Abdel Rahman m Hashem, phd

CONTACT

226401884ahmed@endohashem.com

Ahmed Abdel Rahman Hashem, phd

CONTACT

226401884ahmed@endohashem.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 22, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)