Back to resultsAssessment of Postoperative Pain and Bacterial Load Reduction After Using TruNatomy and ProTaper Next Rotary Systems in Patients With Necrotic Mandibular Molars: A Randomized Clinical Trial
Primary Purpose
Endodontic Treatment
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mechanical instrumentation using rotary file system
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Treatment
Eligibility Criteria
Inclusion Criteria:
- - Medically free patients.
- Mandibular permanent molar teeth:
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pain.
- Slight widening in the periodontal membrane space or with periapical radiolucency
- Patient's age ranges between 22 to 45 years with no sex predilection.
- Patients who can understand Modified Visual Analogue Scale (VAS).
- Patients' acceptance to participate in the trial.
- Patients able to sign informed consent.
Exclusion Criteria:
- - Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
- Teeth that show association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
- Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
- No restorability: Hopeless tooth.
- Vital teeth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ProTaper Next rotary file system (Dentsply Sirona)
TruNatomy rotary system (Dentsply Sirona)
Arm Description
Outcomes
Primary Outcome Measures
Intensity of postoperative pain
Postoperative pain will be measured by modified VAS at 6, 12, 24 and 48 hours post-obturation.
The modified VAS consists of from 0-10 point scale anchored by two extremes "No pain" and "pain as bad as could be". The patients will be asked to choose the mark on an appendix that represents their level of pain. Pain level will be assigned to one of four categorical scores:
None (0)
Mild (1-3)
Moderate (4-6)
Severe (7-10) numerical rating scale (NRS) at 6, 12, 24 and 48 hours post-obturation and at 6, 12, 24 and 48 hours post-obturation.
Secondary Outcome Measures
Bacterial load reduction
Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04862702
Brief Title
Assessment of Postoperative Pain and Bacterial Load Reduction After Using TruNatomy and ProTaper Next Rotary Systems in Patients With Necrotic Mandibular Molars: A Randomized Clinical Trial
Official Title
Assessment of Postoperative Pain and Bacterial Load Reduction After Using TruNatomy and ProTaper Next Rotary Systems in Patients With Necrotic Mandibular Molars: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to assess the effect of rotary instrumentation using ProTaper Next rotary system versus TruNatomy rotary system on postoperative pain and the bacterial load reduction following single visit root canal treatment in necrotic mandibular molars.
Detailed Description
In the last years several rotary systems had launched to the market for mechanical preparation. The new era in the mechanical instrumentation aims to preserve the maximum amount of the peri-cervical dentine without affecting the proper cleaning and bacterial elimination. This will improve the long-term survival of the tooth with appropriate removal of microbes and microbial irritants.
ProTaper Next is a rotary system made from M wire. It is characterized by an innovative off-centered rectangular cross section that is suggested to give the files a snake-like swaggering movement as it advances into the root canal. This movement minimizes the engagement between the file and dentin and improves extruding debris out of the canal.
TruNatomy (Dentsply Sirona), is recently introduced as a new generation of rotary file system. TruNatomy files are designed to shape root canal systems to a continuously tapering preparation with maximum preservation of peri-cervical dentine. TruNatomy system offers a more safety, simplicity, improved cutting efficiency and mechanical properties compared to previous generations of rotating instruments, Many researches had been conducted to address the effect of ProTaper Next on post-operative pain considering it the most commonly used system. Thus, this study will be performed to evaluate and compare the influence of using the two systems on the intensity of postoperative pain and bacterial load reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The assistant supervisor is the one who will generate the random sequence, assign the participants to the intervention or control groups and the only one who knows whether A or B represents the intervention or the control.
The operators will enroll the participants after they find the eligible ones and confirm with the assistant supervisor.
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ProTaper Next rotary file system (Dentsply Sirona)
Arm Type
Active Comparator
Arm Title
TruNatomy rotary system (Dentsply Sirona)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
mechanical instrumentation using rotary file system
Intervention Description
the mechanical preparation will be performed using rotary file system
Primary Outcome Measure Information:
Title
Intensity of postoperative pain
Description
Postoperative pain will be measured by modified VAS at 6, 12, 24 and 48 hours post-obturation.
The modified VAS consists of from 0-10 point scale anchored by two extremes "No pain" and "pain as bad as could be". The patients will be asked to choose the mark on an appendix that represents their level of pain. Pain level will be assigned to one of four categorical scores:
None (0)
Mild (1-3)
Moderate (4-6)
Severe (7-10) numerical rating scale (NRS) at 6, 12, 24 and 48 hours post-obturation and at 6, 12, 24 and 48 hours post-obturation.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Bacterial load reduction
Description
Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Medically free patients.
Mandibular permanent molar teeth:
Diagnosed clinically with pulp necrosis.
Absence of spontaneous pain.
Slight widening in the periodontal membrane space or with periapical radiolucency
Patient's age ranges between 22 to 45 years with no sex predilection.
Patients who can understand Modified Visual Analogue Scale (VAS).
Patients' acceptance to participate in the trial.
Patients able to sign informed consent.
Exclusion Criteria:
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
Pregnant women: Avoid radiation exposure, anesthesia, and medication.
If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
Teeth that show association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
No restorability: Hopeless tooth.
Vital teeth.
Immature teeth.
Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yasmin Hamdy Hussein AbdAlmoniem, masters
Phone
01273398477
Email
Yasmin.Hamdy@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Assessment of Postoperative Pain and Bacterial Load Reduction After Using TruNatomy and ProTaper Next Rotary Systems in Patients With Necrotic Mandibular Molars: A Randomized Clinical Trial
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