NCT05847738

Brief Summary

This is a randomized controlled parallel clinical, prospective split mouth, triple blinded study. Sample size calculation was conducted and it was 25 subjects per group for a total of 50 sides to compensate for drop-outs. Patient selection and preparation: All root canal treatments were performed by a single endodontic consultant. All subjects were selected from walk in patients presented to the endodontic clinic of the British university in Egypt. Cases that met the inclusion criteria where selected for this study. All patients were verbally informed about the procedure's benefits and that the results of the treatment will be used to this study and the risks of the procedure was explicitly explained to them. After the verbal consent patients were handed a written form consent to sign upon. All data of post-operative pain were recorded by a second blinded clinician through a visual analog scale (VAS). Post-operative monitoring periods will be recorded in 12 hours, 24 hours, 3 days and one week Data was sent to the statistician with group names only to fulfill the triple blinding criteria and results will be interpreted

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

15 days

First QC Date

April 19, 2023

Last Update Submit

May 4, 2023

Conditions

Pain Assessment

Outcome Measures

Primary Outcomes (4)

  • Pain assessment at 12 hours

    post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded

    12 hours

  • Pain assessment at 24 hours

    Comparative post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded

    24 hours

  • Pain assessment at 3 days

    post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded

    3days

  • Pain assessment at 1 week

    post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded

    1 week

Study Arms (2)

Group A: (left side of the patient

prepared 2 sizes larger than the IBF, to size 35#/.04 mesial canals and 40#/.04 distal canals.

Behavioral: Pain assessment

Group B (right side of the patient

prepared 3 sizes larger than the IBF, to size 40#/.04 mesial canals and 45#/.04 distal canals.

Behavioral: Pain assessment

Interventions

Pain assessmentBEHAVIORAL

Pain was assesd postoperatively in both groups at time intervals

Group A: (left side of the patientGroup B (right side of the patient

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All types of adult population

You may qualify if:

  • Age: 20-50
  • Gender: Males and Females, random selection.
  • Systemic status: healthy patients (Category: American Society of Anaesthesiologists class 1)
  • Bilateral exposed mandibular first or second permanent molars
  • Molars should have separate mesial and distal roots
  • Mesial roots confirmed to be type three root canal system
  • Distal root confirmed to be type one root canal system
  • Normal periapical radiograph and no bone changes
  • Symptomatic irreversible pulpitis
  • I.B.F. in mesial roots not more than #20, and distal root not more than #30

You may not qualify if:

  • Type two root canal system in mesial roots
  • Type two or three root canal systems in distal roots
  • Signs of apical involvement in the radiograph
  • Any systemic conditions altering the treatment or requiring medications or precautions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British university

Cairo, El Shrouk, Egypt

Location

Related Publications (1)

  • Kataia MM, Kataia EM, Khalil HF, Seoud MAE. Post-operative pain after root canal preparation with different apical finishing sizes a triple blinded split mouth clinical trial. BMC Oral Health. 2024 Jul 16;24(1):800. doi: 10.1186/s12903-024-04527-9.

    PMID: 39014316DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 8, 2023

Study Start

March 15, 2023

Primary Completion

March 30, 2023

Study Completion

April 15, 2023

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations

EG(1)