Pain, PostoperativeNCT06081335
Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial
A study testing EdgeEndo x7 continuous rotation files and EdgeOne Fire reciprocating files in people with Pain, Postoperative and Irreversible Pulpitis, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Irreversible Pulpitis, Apical Periodontitis
- What is being tested?
- EdgeEndo x7 continuous rotation files and EdgeOne Fire reciprocating files
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Mar 2023to 5 Jun 2023
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single rooted mandibular second premolar teeth with complete root formation
- Pulpal diagnosis: Symptomatic irreversible pulpitis
- Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area
- Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization
Who cannot join
- The presence of any systemic disease or allergic reactions
- Pregnant and lactating females
- Patients on antibiotic or anti-inflammatory medication
- Use of analgesics a week prior to treatment
- A radiographically untraceable canal or an excessively curved root
- The presence of periapical radiolucency or sinus tract.
Show all 10Show fewer
- Teeth with open apices
- Severe periodontal disease (generalized or localized to the tooth in question)
- Absence of bleeding in the pulp chamber on access cavity preparation
- Internal or external resorption
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain Shams University
Cairo, Select A State Or Province, 11765
Ain Shams University
Cairo, 11765
About this study
The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.
- Being tested
- EdgeEndo x7 continuous rotation files, EdgeOne Fire reciprocating files
- Keywords
- pain, substance P, continuous rotation, reciprocation
- Medical subject headings
- Pain, Postoperative, Periapical Periodontitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdgeEndo x7 continuous rotation filesDevice
endodontic files operating in continuous rotation
EdgeOne Fire reciprocating filesDevice
endodontic files operating in reciprocating motion
| Study group | Role | What they receive |
|---|---|---|
| Continuous Rotation group | Active comparator | EdgeEndo x7 continuous rotation files system (Albuquerque, New Mexico, USA) Receives: Device: EdgeEndo x7 continuous rotation files |
| Reciprocation group | Active comparator | EdgeOne Fire reciprocating files system (Albuquerque, New Mexico, USA) Receives: Device: EdgeOne Fire reciprocating files |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in substance P levels
tested by radioimmunacy (ELISA)
Measured: pre-operatively and after 5 days at the beginning of the second visit
post operative pain levels
Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain
Measured: pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Mar 2023
- Primary completion5 Apr 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Talaat, Ain Shams University
- Investigators
- maram obeid, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081335
- Sponsor's protocol ID
- 945
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdel-Baset ST, Fahmy SH, Obeid MF. Can instrumentation kinematics affect postoperative pain and substance P levels? A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):102. doi: 10.1186/s12903-024-03882-x.
PubMed 38233887
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06081335
- Acronym / sponsor ID
- 945
- Keywords
- pain, substance P, continuous rotation, reciprocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 13 Oct 2023 (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.
The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Rotation group | Active comparator | Device: EdgeEndo x7 continuous rotation filesEdgeEndo x7 continuous rotation files system (Albuquerque, New Mexico, USA) |
| Reciprocation group | Active comparator | Device: EdgeOne Fire reciprocating filesEdgeOne Fire reciprocating files system (Albuquerque, New Mexico, USA) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Single rooted mandibular second premolar teeth with complete root formation
- Pulpal diagnosis: Symptomatic irreversible pulpitis
- Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area
- Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization
Key exclusion criteria (10 listed)
- The presence of any systemic disease or allergic reactions
- Pregnant and lactating females
- Patients on antibiotic or anti-inflammatory medication
- Use of analgesics a week prior to treatment
- A radiographically untraceable canal or an excessively curved root
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 |
|---|---|---|
| EdgeEndo x7 continuous rotation filesendodontic files operating in continuous rotation | Device | Continuous Rotation group |
| EdgeOne Fire reciprocating filesendodontic files operating in reciprocating motion | Device | Reciprocation group |
Primary outcome
difference in substance P levels
Time frame: pre-operatively and after 5 days at the beginning of the second visit
tested by radioimmunacy (ELISA)
post operative pain levels
Time frame: pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours
Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain
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 15 Nov 2023.
- Derived from this study: PubMed 38233887Abdel-Baset ST, Fahmy SH, Obeid MF. Can instrumentation kinematics affect postoperative pain and substance P levels? A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):102. doi: 10.1186/s12903-024-03882-x.
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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.
maram obeid study chair
professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EdgeEndo x7 continuous rotation files and EdgeOne Fire reciprocating files in people with Pain, Postoperative and Irreversible Pulpitis, run by Ain Shams University at 2 sites 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 4 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: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
difference in substance P levels (time frame: pre-operatively and after 5 days at the beginning of the second visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06081335, which also lists 1 linked publication.
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 15 Nov 2023.