Endodontic TreatmentNCT04862702
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
A study testing mechanical instrumentation using rotary file system in people with Endodontic Treatment, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Treatment
- What is being tested?
- mechanical instrumentation using rotary file system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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.
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- Patients who can understand Modified Visual Analogue Scale (VAS).
- Patients' acceptance to participate in the trial.
- Patients able to sign informed consent.
Who cannot join
- - 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.
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- No restorability: Hopeless tooth.
- Vital teeth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Endodontic Treatment
- Being tested
- mechanical instrumentation using rotary file system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical instrumentation using rotary file systemDevice
the mechanical preparation will be performed using rotary file system
| Study group | Role | What they receive |
|---|---|---|
| ProTaper Next rotary file system (Dentsply Sirona) | Active comparator | Not described Receives: Device: mechanical instrumentation using rotary file system |
| TruNatomy rotary system (Dentsply Sirona) | Experimental | Not described Receives: Device: mechanical instrumentation using rotary file system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (1)
Bacterial load reduction
Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study startSep 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic TreatmentStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasmin hamdy hussien, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862702
- Sponsor's protocol ID
- ENDO:3-3-5
- Status last verified
- Apr 2021
- First submitted
- 14 Oct 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04862702
- Acronym / sponsor ID
- ENDO:3-3-5
- Conditions
- Endodontic Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProTaper Next rotary file system (Dentsply Sirona) | Active comparator | Device: mechanical instrumentation using rotary file system |
| TruNatomy rotary system (Dentsply Sirona) | Experimental | Device: mechanical instrumentation using rotary file system |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- - 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
Key exclusion criteria (10 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical instrumentation using rotary file systemthe mechanical preparation will be performed using rotary file system | Device | ProTaper Next rotary file system (Dentsply Sirona), TruNatomy rotary system (Dentsply Sirona) |
Primary outcome
Intensity of postoperative pain
Time frame: 48 hours
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: 1. None (0) 2. Mild (1-3) 3. Moderate (4-6) 4. 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.
1 secondary outcome
Bacterial load reduction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical instrumentation using rotary file system in people with Endodontic Treatment, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasmin Hamdy Hussein AbdAlmoniem, masters (01273398477, Yasmin.Hamdy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of postoperative pain (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.