Root Canal InfectionNCT04990115
Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics
A study testing root canal shaping in people with Root Canal Infection, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study was conducted to compare the antibacterial effect and degree of postoperative pain of single rotary and reciprocating file systems during endodontic therapy Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- root canal shaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Mar 2021
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mandibular premolars
- single rooted
- single canalled
- necrotic pulps
- asymptomatic apical periodontitis
Who cannot join
- gross caries
- root/crown fracture
- sinus tract
- swelling
- intake of antibiotics within previous 3 months
- pain with percussion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacterial Reduction and Post Operative Pain After Cleaning and Shaping of Root Canals With Single File Systems Used in Different Kinematics
This study was conducted to compare the antibacterial effect and degree of postoperative pain of single rotary and reciprocating file systems during endodontic therapy
Read the detailed description
Introduction: Instrumentation kinematic is one of the many aspects of shaping files that underwent heavy development through the last decade. The impact of the type of motion used to drive shaping instruments was heavily studied but mostly in-vitro. More randomized clinical trials are needed to achieve a reliable body of data concerning the issue.
Aim: This study aimed to evaluate the effect of varying shaping files' kinematics on bacterial reduction, post-operative pain and the incidence of flare-ups. Methods: Necrotic, asymptomatic, single-rooted mandibular premolars with single canals were used in the study, where 46 patients were randomly allocated to two groups. In the first group, WaveOne Gold was used for mechanical preparation while One Shape was used in the second group. Samples were taken preoperatively (S1) and after chemomechanical preparation (S2). Bacterial reduction was evaluated and compared between both groups via culturing technique and quantitative analysis by real-time polymerase chain reaction (qPCR). Post-operative pain and the incidence of flare-ups were also evaluated using the visual analog scale (VAS) method.
- Conditions
- Root Canal Infection
- Being tested
- root canal shaping
- Keywords
- Reciprocation, Kinematics, Bacterial reduction, post-operative pain, endodontic flare-ups
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal shapingOther
root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| rotation | Active comparator | root canal preparation performed using rotating instruments Receives: Other: root canal shaping |
| reciprocation | Active comparator | root canal preparation performed using reciprocating instruments Receives: Other: root canal shaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial reduction
pre-instrumentation and post-instrumentation bacterial cultures to detect change in bacterial count after root canal instrumentation with the different kinematics
Measured: up to 1 hour
post operative pain
Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest
Measured: after the treatment visit by 24 hours
post operative pain
Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest
Measured: after the treatment visit by 48 hours
post operative pain
Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest
Measured: after the treatment visit by 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Aug 2020
- Primary completion1 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies of the same condition, open and under way.
- 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
- Model description
- The trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehab El Din Mohamed Saber, Ain Shams University
- Investigators
- shehabeldin M Saber, phd, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990115
- Sponsor's protocol ID
- FDASU-RECD091615
- Status last verified
- Sep 2021
- First submitted
- 26 Jun 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Reduction and Post Operative Pain After Cleaning and Shaping of Root Canals With Single File Systems Used in Different Kinematics
- ClinicalTrials.gov ID
- NCT04990115
- Acronym / sponsor ID
- FDASU-RECD091615
- Conditions
- Root Canal Infection
- Keywords
- Reciprocation, Kinematics, Bacterial reduction, post-operative pain, endodontic flare-ups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Aug 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 was conducted to compare the antibacterial effect and degree of postoperative pain of single rotary and reciprocating file systems during endodontic therapy
Detailed description
Introduction: Instrumentation kinematic is one of the many aspects of shaping files that underwent heavy development through the last decade. The impact of the type of motion used to drive shaping instruments was heavily studied but mostly in-vitro. More randomized clinical trials are needed to achieve a reliable body of data concerning the issue.
Aim: This study aimed to evaluate the effect of varying shaping files' kinematics on bacterial reduction, post-operative pain and the incidence of flare-ups. Methods: Necrotic, asymptomatic, single-rooted mandibular premolars with single canals were used in the study, where 46 patients were randomly allocated to two groups. In the first group, WaveOne Gold was used for mechanical preparation while One Shape was used in the second group. Samples were taken preoperatively (S1) and after chemomechanical preparation (S2). Bacterial reduction was evaluated and compared between both groups via culturing technique and quantitative analysis by real-time polymerase chain reaction (qPCR). Post-operative pain and the incidence of flare-ups were also evaluated using the visual analog scale (VAS) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trial
| Arm | Type | Receives |
|---|---|---|
| rotation | Active comparator | Other: root canal shapingroot canal preparation performed using rotating instruments |
| reciprocation | Active comparator | Other: root canal shapingroot canal preparation performed using reciprocating instruments |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- mandibular premolars
- single rooted
- single canalled
- necrotic pulps
- asymptomatic apical periodontitis
Key exclusion criteria (6 listed)
- gross caries
- root/crown fracture
- sinus tract
- swelling
- intake of antibiotics within previous 3 months
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 |
|---|---|---|
| root canal shapingroot canal treatment | Other | reciprocation, rotation |
Primary outcome
bacterial reduction
Time frame: up to 1 hour
pre-instrumentation and post-instrumentation bacterial cultures to detect change in bacterial count after root canal instrumentation with the different kinematics
post operative pain
Time frame: after the treatment visit by 24 hours
Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest
post operative pain
Time frame: after the treatment visit by 48 hours
Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest
post operative pain
Time frame: after the treatment visit by 72 hours
Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Root Canal Infection
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Nanozymes in Endodontics
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Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
Not yet recruitingEarly Phase 1
Frankincense Versus Sodium Hypochlorite for Root Canal Disinfection
Pulp Necrosis, Root Canal Infection
Recruiting
Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses
Acute Apical Abscess
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.
shehabeldin M Saber, phd principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal shaping in people with Root Canal Infection, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial reduction (time frame: up to 1 hour). The study lists 4 primary outcomes in all. 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 8 Sep 2021.