Root Canal TreatmentNCT06207019
Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study
A study testing Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold in people with Root Canal Treatment, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Root Canal Treatment
- What is being tested?
- Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2020to 5 Mar 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Teeth with a single root canal with nearly the same apical diameter (#15)
- Vital pulp exposures due to caries or trauma with asymptomatic pulpitis
- Restorable teeth
Who cannot join
- • Patients with immune deficiencies or systemic illnesses
- Pregnant women
- Cases of re-treatment
- Symptomatic non-vital teeth that require root canal therapy
- Presence of root resorption
- Teeth with anatomic variations
Show all 10Show fewer
- A cute periapical abscess cases with pus discharge
- A patient who has several teeth that need to be treated in order to eliminate the likelihood of pain referral
- Periodontal diseases
- Patients on analgesics, anti-inflammatory drugs, sedatives, or antibiotics seven days before therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Tanta University, Egypt
Tanta, Gharbia Governorate, 31773
About this study
The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems
Read the detailed description
The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems.Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm [10].
- Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients.
- Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics.
- Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced).
- Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics).
The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form filled out completely
- Conditions
- Root Canal Treatment
- Being tested
- Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold
- Keywords
- Hyflex/EDM; Post-operative pain; Single-file systems; Wave One Gold; XP-endo shaper.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyflex EDM , The XP-endo Shaper, Primary WaveOne GoldDevice
rotary single files
| Study group | Role | What they receive |
|---|---|---|
| Hyflex EDM | Active comparator | Hyflex EDM One File (25/) with variable taper was used in continuous rotation at 500 rpm and 2.5 Ncm in a circumferential brushing action in the coronal and middle thirds, then in a pecking action for three to five cycles until the WL was reached. Receives: Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold |
| The XP-endo Shaper | Active comparator | The XP-endo Shaper (30/0.01) was used in rotation mode at 800 rpm and 1.0 Ncm torque. Long, gentle strokes with amplitudes of 3-4 mm were used to go down to adjusted WL in three to five cycles. After it reached the WL over the adjusted WL, it was subjected to five more up-and-down motions. Receives: Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold |
| Primary WaveOne Gold | Active comparator | Primary WaveOne Gold (25/07) was applied three times in a reciprocating motion; a gradual in-and-out pecking movement was utilized as directed by the manufacturer till the WL was reached. Receives: Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain evaluation
Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm [10]. • Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients. • Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics. • Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced). • Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics). The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form fill
Measured: 24 hours to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start30 Jan 2020
- Primary completion11 Jan 2021
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdel Moneim Ahmed Elkalashy, Tanta University
- Investigators
- Abdel Moneim A. Elkalashy, Assis.lecturer, Principal investigator, Assis.lecturer at endodontic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207019
- Sponsor's protocol ID
- #R-END-1-20-5
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06207019
- Acronym / sponsor ID
- #R-END-1-20-5
- Conditions
- Root Canal Treatment
- Keywords
- Hyflex/EDM; Post-operative pain; Single-file systems; Wave One Gold; XP-endo shaper.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 16 Jan 2024 (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 goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems
Detailed description
The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems.Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm [10].
- Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients.
- Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics.
- Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced).
- Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics).
The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form filled out completely
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyflex EDM | Active comparator | Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne GoldHyflex EDM One File (25/) with variable taper was used in continuous rotation at 500 rpm and 2.5 Ncm in a circumferential brushing action in the coronal and middle thirds, then in a pecking action for three to five cycles until the WL was reached. |
| The XP-endo Shaper | Active comparator | Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne GoldThe XP-endo Shaper (30/0.01) was used in rotation mode at 800 rpm and 1.0 Ncm torque. Long, gentle strokes with amplitudes of 3-4 mm were used to go down to adjusted WL in three to five cycles. After it reached the WL over the adjusted WL, it was subjected to five more up-and-down motions. |
| Primary WaveOne Gold | Active comparator | Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne GoldPrimary WaveOne Gold (25/07) was applied three times in a reciprocating motion; a gradual in-and-out pecking movement was utilized as directed by the manufacturer till the WL was reached. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Teeth with a single root canal with nearly the same apical diameter (#15)
Key exclusion criteria (10 listed)
- • Patients with immune deficiencies or systemic illnesses
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 |
|---|---|---|
| Hyflex EDM , The XP-endo Shaper, Primary WaveOne Goldrotary single files | Device | Hyflex EDM, Primary WaveOne Gold, The XP-endo Shaper |
Primary outcome
Postoperative pain evaluation
Time frame: 24 hours to 7 days
Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm [10]. • Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients. • Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics. • Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced). • Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics). The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form fill
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 16 Jan 2024.
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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.
Abdel Moneim A. Elkalashy, Assis.lecturer principal investigator
Assis.lecturer at endodontic department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold in people with Root Canal Treatment, run by Tanta 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 3 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 16 Jan 2024. 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?
Postoperative pain evaluation (time frame: 24 hours to 7 days). 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 16 Jan 2024.