Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04990115
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Root Canal Infection	Other: root canal shaping	N/A

Detailed Description

Introduction: Instrumentation kinematic is one of the many aspects of shaping files that underwent heavy development through the last decade. The impact of the type of motion used to drive shaping instruments was heavily studied but mostly in-vitro. More randomized clinical trials are needed to achieve a reliable body of data concerning the issue.

Aim: This study aimed to evaluate the effect of varying shaping files' kinematics on bacterial reduction, post-operative pain and the incidence of flare-ups. Methods: Necrotic, asymptomatic, single-rooted mandibular premolars with single canals were used in the study, where 46 patients were randomly allocated to two groups. In the first group, WaveOne Gold was used for mechanical preparation while One Shape was used in the second group. Samples were taken preoperatively (S1) and after chemomechanical preparation (S2). Bacterial reduction was evaluated and compared between both groups via culturing technique and quantitative analysis by real-time polymerase chain reaction (qPCR). Post-operative pain and the incidence of flare-ups were also evaluated using the visual analog scale (VAS) method.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trialThe trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trial
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Treatment
• Official Title: Bacterial Reduction and Post Operative Pain After Cleaning and Shaping of Root Canals With Single File Systems Used in Different Kinematics
• Actual Study Start Date: Aug 1, 2020
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: rotation root canal preparation performed using rotating instruments	Other: root canal shaping; root canal treatment
Active Comparator: reciprocation root canal preparation performed using reciprocating instruments	Other: root canal shaping; root canal treatment

Outcome Measures

Primary Outcome Measures

1. bacterial reduction [up to 1 hour]

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

2. post operative pain [after the treatment visit by 24 hours]

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

3. post operative pain [after the treatment visit by 48 hours]

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

4. post operative pain [after the treatment visit by 72 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• mandibular premolars

• single rooted

• single canalled

• necrotic pulps

• asymptomatic apical periodontitis

Exclusion Criteria:

• gross caries

• root/crown fracture

• sinus tract

• swelling

• intake of antibiotics within previous 3 months

• pain with percussion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry. Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

• Principal Investigator: shehabeldin M Saber, phd, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shehab El Din Mohamed Saber, professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04990115
• Other Study ID Numbers: FDASU-RECD091615
• First Posted: Aug 4, 2021
• Last Update Posted: Sep 8, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shehab El Din Mohamed Saber, professor, Ain Shams University: Reciprocation; Kinematics; Bacterial reduction; post-operative pain; endodontic flare-ups

Study Results

No Results Posted as of Sep 8, 2021