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Clinical Trials/NCT04767399
NCT04767399UnknownNot Applicable

Comparison of Postoperative Pain After Root Canal Preparation, in Single and Multiple Visits, With Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial.

Riyadh Elm University1 site in 1 country160 target enrollmentStarted: September 10, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
160
Locations
1
Primary Endpoint
Visual analogue scale

Study Overview

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.

  1. To assess the influence of reciprocating and rotary single-file systems instrumentation on post-operative pain.

Detailed Description

Subjects allocation and randomization method:

  • All diagnoses and treatment procedures will be performed by a single operator in one visit or multiple visits to eliminate or minimize individual variability in the treatment between clinicians.
  • Total of 160 patients, as per the inclusion criteria will be intervened. This will be divided into two groups as follows:
  1. Group A (n=80) single visit.
  2. Group B (n=80) multiple visits.
  • Group A and B will be subdivided into two groups (each group=40) based on the motion of the files to be used either Reciprocation EOF (Edge one Fire file) or Rotational motion PN (ProTaper Next files). Each subgroup will be divided based on either the tooth is vital or non-vital (each subgroup=20) as shown in study design (Figure 1).

(Figure 1)

  • A pulpal and periapical diagnoses will be done for each tooth on taking careful history, clinical and radiographic examination based on the American Association of Endodontists (AAE 2008) diagnostic guidelines.
  • The treatments in groups A or B by ProTaper Next or Edge one Fire will be randomized with sequentially numbered opaque sealed envelopes (SNOSE) with 40 patients in PN group and 40 patients in EOF group with allocation sequence and assigning to intervention which will be done by blinded second investigator at the time of cleaning and shaping, concealed from operator to reduce bias.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Single visit

Experimental

root canal treatment will be done in one visit

Intervention: protaper next (Behavioral)

multiple visit

Experimental

root canal treatment will be done in multiple visit

Intervention: protaper next (Behavioral)

Outcomes

Primary Outcomes

Visual analogue scale

Time Frame: 24 months

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

Secondary Outcomes

  • Verbal analogue scale(24 moths)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yahia Abdullah Alyami

postgraduate resident

Riyadh Elm University

Study Sites (1)

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