NCT04767399

Brief Summary

Comparison of Postoperative Pain after Root Canal preparation, in Single and Multiple Visits, with Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Aim:1. Compare between the postoperative pain after root canal preparation, in single and multiple visits. 2\. To assess the influence of reciprocating and rotary single-file systems instrumentation on post-operative pain.

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
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 12, 2021

Last Update Submit

February 27, 2021

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    appointment treatment at 24 month \[ Time Frame: 12, 24, 48, h \] where 0 out of 10 scale will indicates no pain and 10 out of 10 indicates worse pain

    24 months

Secondary Outcomes (1)

  • Verbal analogue scale

    24 moths

Study Arms (2)

Single visit

EXPERIMENTAL

root canal treatment will be done in one visit

Behavioral: protaper next

multiple visit

EXPERIMENTAL

root canal treatment will be done in multiple visit

Behavioral: protaper next

Interventions

protaper nextBEHAVIORAL

rotary systems used on patients need root canal treatment

Also known as: Edge-one fire
Single visitmultiple visit

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a. All permanent teeth diagnosed with vital or non-vital pulps and need nonsurgical root canal treatment.
  • b. Symptomatic, Asymptomatic maxillary and mandibular teeth with apical radiolucency c. All males and females with age between 19 to 60 years.

You may not qualify if:

  • a. Teeth with Previously treated b. Teeth need surgical treatment. c. Primary teeth. d. Patients with sinus tract, periapical abscess and who had previously medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yahia Abdullah Alyami

Riyadh, 23323, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Yahia Alyami

CONTACT

0566415159yahya.a.alyami2019@student.riyadh.edu.sa

Yahia Alyami

CONTACT

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
postgraduate resident

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 23, 2021

Study Start

September 10, 2020

Primary Completion

September 10, 2021

Study Completion

November 10, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

SA(1)