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Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive

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ClinicalTrials.gov Identifier: NCT03338322
Recruitment Status : Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Yaser Abu Bakr, Cairo University

Brief Summary:
assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars.

Condition or disease Intervention/treatment Phase
Postoperative Pain Device: Twisted file adaptive Device: Reciproc Not Applicable

Detailed Description:
In root canal treatment of mandibular molar teeth in patients having necrotic pulp with symptomatic or asymptomatic apical periodontitis, Is there difference in postoperative pain after instrumentation between two different kinematics; adaptive motion using Twisted File Adaptive and reciprocation motion using Reciproc

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive In Instrumentation Of Necrotic Mandibular Molars: A Randomized Clinical Trial
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Twisted file adaptive
Files that are used in root canal preparation in adaptive motion
Device: Twisted file adaptive
Endodontic files that are used in preparation of root canals with adaptive motion
Active Comparator: Reciproc
Reciproc files are used in root canal preparation with reciprocation motion
Device: Reciproc
Endodontic files that are used in root canal preparation with reciprocation motion



Primary Outcome Measures :
  1. Post instrumentation pain [ Time Frame: up to 7 days ]
    post instrumentation pain will be recorded by the patient using numerical rating scale (0-10) will be used to record pain intensity


Secondary Outcome Measures :
  1. analgesic intake [ Time Frame: up to 7 days ]
    number of analgesic intake will be recorded by the patient

  2. Colony forming units [ Time Frame: 6 hours ]
    calculation of colony forming units before and after instrumentation



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients who are medically free from any systemic disease that may contraindicate our interventions.
  2. Patient's age between 18-60 years old.
  3. Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22.
  4. Positive patient's acceptance for participation in the study.

Exclusion Criteria:

  1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation.
  2. Teeth with vital pulps or Symptomatic irreversible pulpitis.
  3. Pregnant patients or lactating because of radiographic hazards and use of analgesics27.
  4. Any known sensitivity or adverse reactions to ibuprofen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338322


Contacts
Contact: abu bakr +201225877183 ahmed.abubakr@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

Responsible Party: Ahmed Yaser Abu Bakr, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03338322     History of Changes
Other Study ID Numbers: twisted file adaptive 1987
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: participant data will be recorded and shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ahmed Yaser Abu Bakr, Cairo University:
postoperative pain
reciproc
twisted file adaptive

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms