Root Canal TherapyNCT04277520
Postoperative Pain Assessment After Using Different Kinematics
A study testing Root canal therapy in people with Root Canal Therapy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Root Canal Therapy
- What is being tested?
- Root canal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 1 Jul 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
- No healthy volunteers
- Adult
Who may be able to join
- Medically free patients with good health.
- Patient's age between 18_50
- Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis
- Positive patient's acceptance for participation in the study
Who cannot join
- Root resorption
- Non restorable teeth.
- Pregnancy.
- Systematic disease as hypertension ,diabetes .
- Psychologically disturbance.
- Need for prophylactic antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain Assessment After Using Different Kinematics During Endodontic Instrumentation (Randomized Clinical Trial)
The aim of this study is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion.
Read the detailed description
Post operative pain assessment is done at the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, with 0 representing no pain and 10 representing the most severe pain imaginable.These scores were marked in intervals of 6, 12, 24, 48 and 72 h following endodontic treatment.
- Conditions
- Root Canal Therapy
- Being tested
- Root canal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal therapyProcedure or surgery
Different types of instrumentation motions during root canal therapy
| Study group | Role | What they receive |
|---|---|---|
| Continous rotation | Active comparator | instrumentation was done in continuous rotation motion Receives: Procedure: Root canal therapy |
| Reciprocation | Active comparator | instrumentation was done in reciprocation motion Receives: Procedure: Root canal therapy |
| Adaptive motion | Active comparator | instrumentation was done in adaptive motion Receives: Procedure: Root canal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
monitoring the change in postoperative pain following root canal treatment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Measured: 72 hours
Secondary outcomes (3)
6-hour post operative pain assessment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 6 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Measured: 6 hours
12-hour post operative pain assessment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 12 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
Measured: 12 hours
24-hour post operative pain assessment
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 24 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
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 posted20 Feb 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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 Root Canal TherapyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mokhtar Nagy, Ain Shams University
- Investigators
- Ahmed Hashem, PhD, Study director, Faculty of Dentistry, Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277520
- Sponsor's protocol ID
- ASFD-ENDO-1
- Status last verified
- Jul 2021
- First submitted
- 18 Feb 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.
PubMed 23741536
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Assessment After Using Different Kinematics During Endodontic Instrumentation (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04277520
- Acronym / sponsor ID
- ASFD-ENDO-1
- Conditions
- Root Canal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 20 Feb 2020 (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 is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion.
Detailed description
Post operative pain assessment is done at the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, with 0 representing no pain and 10 representing the most severe pain imaginable.These scores were marked in intervals of 6, 12, 24, 48 and 72 h following endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continous rotation | Active comparator | Procedure: Root canal therapyinstrumentation was done in continuous rotation motion |
| Reciprocation | Active comparator | Procedure: Root canal therapyinstrumentation was done in reciprocation motion |
| Adaptive motion | Active comparator | Procedure: Root canal therapyinstrumentation was done in adaptive motion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Medically free patients with good health.
- Patient's age between 18_50
- Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis
- Positive patient's acceptance for participation in the study
Key exclusion criteria (6 listed)
- Root resorption
- Non restorable teeth.
- Pregnancy.
- Systematic disease as hypertension ,diabetes .
- Psychologically disturbance.
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 therapyDifferent types of instrumentation motions during root canal therapy | Procedure or surgery | Adaptive motion, Continous rotation, Reciprocation |
Primary outcome
monitoring the change in postoperative pain following root canal treatment
Time frame: 72 hours
At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain
3 secondary outcomes
6-hour post operative pain assessment
Time frame: 6 hours
12-hour post operative pain assessment
Time frame: 12 hours
24-hour post operative pain assessment
Time frame: 24 hours
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 27 Jul 2021.
- Background: PubMed 23741536Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.
- Individual participant dataSharing planned: No
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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.
Ahmed Hashem, PhD study director
Faculty of Dentistry, Ain Shams university
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 therapy in people with Root Canal Therapy, 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 4 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 27 Jul 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?
monitoring the change in postoperative pain following root canal treatment (time frame: 72 hours). 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 NCT04277520, 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 27 Jul 2021.