Postoperative Pain Following Treatment of Asymptomatic Necrotic Mandibular Molars in Single Visit Using Wave-one Reciprocating Instruments Versus One-Shape Rotary Instruments
Evaluation of the Post Treatment Pain After Instrumentation of Root Canals With a Single File Reciprocating (Wave-One Ni Ti File, DENTSPLY Maillefer) or Rotary(One Shape, Micro Mega, France) File System in Patient With Asymptomatic Necrotic Molars
1 other identifier
interventional
42
0 countries
N/A
Brief Summary
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the use of reciprocating motion in endodontic treatment in necrotic teeth without periapical lesion therefore reduce the post-obtuation pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2018
CompletedDecember 5, 2017
December 1, 2017
4 months
September 24, 2017
December 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative pain
Post operative pain after mechanical preparation with wave one and one shape using VAS scale from 0 to 10 Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment. The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation. The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows: 0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
changes after 6 hours , 24 hours , 48 hours , 7 days The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain from 0 to 10
Study Arms (2)
wave -one reciprocating system
EXPERIMENTALThe reciprocating single file systems WaveOne (Maillefer, Ballaigues, Switzerland) provide more flexibility of the M-wire Ni-Ti alloy, greater resistance to cyclic fatigue and better handling of narrow and curved canals than the traditional Ni-Ti instruments Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created. The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal.
OneShape
EXPERIMENTALOneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06
Interventions
OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06
Eligibility Criteria
You may qualify if:
- Medically free patients
- Patient's age between 25-50 years.
- Mandibular molars diagnosed clinically as necrotic with normal apical tissues.
- Positive patient's acceptance for participation in the study.
- Both genders are included.
- Patients able to sign informed consent.
- Normal periodontal tissues.
- Normal periapical tissues on the radiograph
You may not qualify if:
- Patients with complicating systemic disease.
- Having severe pain and/or acute apical abscesses.
- Under the age of 25 years.
- Patients using antibiotics or analgesic 12 hours before the procedures.
- Having multiple teeth that required treatment.
- With non-restorable and/or periodontally compromised teeth.
- Retreatment cases
- Presence of sinus tract
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master candidate at endodontic department faculty of oral and dental medicine CU
Study Record Dates
First Submitted
September 24, 2017
First Posted
October 4, 2017
Study Start
January 15, 2018
Primary Completion
May 15, 2018
Study Completion
August 15, 2018
Last Updated
December 5, 2017
Record last verified: 2017-12