Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics

NCT04990115 | Completed

• 1 other identifier: FDASU-RECD091615
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to compare the antibacterial effect and degree of postoperative pain of single rotary and reciprocating file systems during endodontic therapy

Conditions

Root Canal Infection

Keywords

Reciprocation; Kinematics; Bacterial reduction; post-operative pain; endodontic flare-ups

Outcome Measures

Primary Outcomes (4)

• bacterial reduction

  pre-instrumentation and post-instrumentation bacterial cultures to detect change in bacterial count after root canal instrumentation with the different kinematics

  up to 1 hour

• post operative pain

  Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest

  after the treatment visit by 24 hours

• post operative pain

  Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest

  after the treatment visit by 48 hours

• post operative pain

  Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest

  after the treatment visit by 72 hours

Study Arms (2)

rotation

ACTIVE COMPARATOR

root canal preparation performed using rotating instruments

Other: root canal shaping

reciprocation

ACTIVE COMPARATOR

root canal preparation performed using reciprocating instruments

Other: root canal shaping

Interventions

root canal shaping OTHER

root canal treatment

reciprocation; rotation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• mandibular premolars
• single rooted
• single canalled
• necrotic pulps
• asymptomatic apical periodontitis

You may not qualify if:

• gross caries
• root/crown fracture
• sinus tract
• swelling
• intake of antibiotics within previous 3 months
• pain with percussion

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry. Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• shehabeldin M Saber, phd

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sequentially generated numbers were placed in opaque envelopes until the intervention was conducted and each participant was asked to select an envelope that determine which group of intervention was assumed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: The trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trial

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: August 4, 2021
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)