Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Max-i-Probe
NaviTip
Sponsored by
About this trial
This is an interventional prevention trial for Symptomatic Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria:
- Age: 16-65 year old.
- Medically free.
- Mandibular posterior teeth with symptomatic irreversible pulpitis.
- No sex predilection
Exclusion Criteria:
- Pregnant females.
- History of allergy to any medication used in the study.
- Preoperative premedication less than 6 hours before procedure.
- Cracked teeth and teeth with badly-decayed crowns.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Max-i-Probe
NaviTip
Arm Description
Outcomes
Primary Outcome Measures
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04119661
Brief Title
Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
Official Title
Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.
Detailed Description
The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Max-i-Probe
Arm Type
Experimental
Arm Title
NaviTip
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Max-i-Probe
Intervention Description
Using Max-i-Probe as endodontic needle during syringe irrigation
Intervention Type
Device
Intervention Name(s)
NaviTip
Intervention Description
Using NaviTip as endodontic needle during syringe irrigation
Primary Outcome Measure Information:
Title
Postoperative pain using a pain-measuring scale
Description
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment
Time Frame
4 hours
Title
Postoperative pain using a pain-measuring scale
Description
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment
Time Frame
12 hours
Title
Postoperative pain using a pain-measuring scale
Description
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment
Time Frame
24 hours
Title
Postoperative pain using a pain-measuring scale
Description
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 16-65 year old.
Medically free.
Mandibular posterior teeth with symptomatic irreversible pulpitis.
No sex predilection
Exclusion Criteria:
Pregnant females.
History of allergy to any medication used in the study.
Preoperative premedication less than 6 hours before procedure.
Cracked teeth and teeth with badly-decayed crowns.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan Amin, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed El-Bayoumi, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20647083
Citation
Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
Results Reference
background
PubMed Identifier
27248848
Citation
Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
Results Reference
background
Learn more about this trial
Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
We'll reach out to this number within 24 hrs