Endodontically Treated TeethNCT04892355
Postoperative Pain After İntracanal Procedures
A study testing Root canal irrigation in people with Endodontically Treated Teeth, run by Afyonkarahisar Health Sciences University.
Trial summary
Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Post-operative pain values of the participants will be recorded and evaluated with the VAS scale. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Root canal irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2022to 6 Nov 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients ranging between 18 and 60 years in age
- Patients that experienced moderate-to-severe pain represented on a visual analogue scale (VAS)
- Maxillar and Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis
Who cannot join
- Any systemic disease and pregnancy in the patient
- Having used analgesic-anti-inflammatory in the last 12 hours and cortisone for the last 6 months
- The patient has bruxism
- Teeth with severe damage
- Teeth with calcified canals
- Teeth with pain to percussion
Show all 10Show fewer
- Teeth with periapical radiolucency
- Teeth with root resorption
- Teeth with an immature / open apex
- Teeth with previous RCT
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial
Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Post-operative pain values of the participants will be recorded and evaluated with the VAS scale.
Postoperative pain values of the techniques will be compared with statistical evaluation.
Read the detailed description
Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Materials and Methods: The study will be carried out on 140 patients with molar teeth diagnosed with irreversible pulpitis. After the root canal preparation is completed, the patients will be divided into 4 groups according to the irrigation activation system; Conventional syringe irrigation (CSI), EDDY, EndoActivator (EA) and Xp-endo Finisher (XPF). After the irrigation process is completed, the root canals will be filled using gutta-percha and canal sealer and the treatment will be completed in one session. Pain values at 6, 24, 48, 72 hours and 7 days after treatment will be evaluated at a 0.05% significance level using the Kruskal-Wallis test.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Root canal irrigation
- Keywords
- EDDY, EndoActivatör, Xp-endo Finisher, Postoperative pain
- Medical subject headings
- Tooth, Nonvital, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal irrigationDevice
Also called EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-
Devices used during root canal irrigation
| Study group | Role | What they receive |
|---|---|---|
| Conventional Syringe Irrigation Group | Experimental | During the final irrigation procedure, a 30 - G side vented needle was placed 2 mm shorter than the working length and was applied without agitation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. Receives: Device: Root canal irrigation |
| Xp Endo Finisher Group | Experimental | Xp Endo Finisher file was used with VDW Silver (VDW) endomotor at 800 rpm speed and 1 Ncm torque according to the manufacturer's instructions. The Xp Endo Finisher file was placed in the canal, 2 mm shorter than the working length, and was used with slow movements of 7-8 mm amplitude in the canal during activation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. Receives: Device: Root canal irrigation |
| EDDY Group | Experimental | An EDDY tip of size 25/04 was used for sonic activation. The EDDY was placed in the duct 2 mm shorter than the working length and the activation process was performed with slow movements with an amplitude of 2-4 mm. In the irrigation process, 5 mL of 2.5% NaOCI was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. Receives: Device: Root canal irrigation |
| Endoactivator Group | Experimental | Medium Endoactivator tip of 25 / .04 size was used for irrigation activation. Medium type was placed in the canal 2 mm shorter than the working length and activation was performed by making short strokes of 2-3 mm. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. Receives: Device: Root canal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial
Preoperative pain of the patients before the treatment was recorded with the VAS scale. Pain levels were classified as 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain .After the treatment of the patients, a pain assessment form was given to the patient in order to evaluate the postoperative pain. Patients were asked to mark their pain levels on the VAS scale. The marking procedure was taught to the patients by a blinded researcher from the groups. When the patients came to the control appointment, VAS scales were collected and the data were analyzed.
Measured: one week(7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start6 Aug 2022 (estimated)
- Primary completion6 Oct 2022 (estimated)
- Study completion6 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies 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
- 4-group clinical trial
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahya Güven, Afyonkarahisar Health Sciences University
- Investigators
- yahya güven, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892355
- Sponsor's protocol ID
- AfyonkarahisarHSU
- Status last verified
- Feb 2022
- First submitted
- 11 May 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT04892355
- Acronym / sponsor ID
- AfyonkarahisarHSU
- Conditions
- Endodontically Treated Teeth
- Keywords
- EDDY, EndoActivatör, Xp-endo Finisher, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 6 Aug 2022 (estimated)
- Primary completion
- 6 Oct 2022 (estimated)
- Study completion
- 6 Nov 2022 (estimated)
- First posted
- 19 May 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.
Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Post-operative pain values of the participants will be recorded and evaluated with the VAS scale.
Postoperative pain values of the techniques will be compared with statistical evaluation.
Detailed description
Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Materials and Methods: The study will be carried out on 140 patients with molar teeth diagnosed with irreversible pulpitis. After the root canal preparation is completed, the patients will be divided into 4 groups according to the irrigation activation system; Conventional syringe irrigation (CSI), EDDY, EndoActivator (EA) and Xp-endo Finisher (XPF). After the irrigation process is completed, the root canals will be filled using gutta-percha and canal sealer and the treatment will be completed in one session. Pain values at 6, 24, 48, 72 hours and 7 days after treatment will be evaluated at a 0.05% significance level using the Kruskal-Wallis test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4-group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Syringe Irrigation Group | Experimental | Device: Root canal irrigationDuring the final irrigation procedure, a 30 - G side vented needle was placed 2 mm shorter than the working length and was applied without agitation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. |
| Xp Endo Finisher Group | Experimental | Device: Root canal irrigationXp Endo Finisher file was used with VDW Silver (VDW) endomotor at 800 rpm speed and 1 Ncm torque according to the manufacturer's instructions. The Xp Endo Finisher file was placed in the canal, 2 mm shorter than the working length, and was used with slow movements of 7-8 mm amplitude in the canal during activation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. |
| EDDY Group | Experimental | Device: Root canal irrigationAn EDDY tip of size 25/04 was used for sonic activation. The EDDY was placed in the duct 2 mm shorter than the working length and the activation process was performed with slow movements with an amplitude of 2-4 mm. In the irrigation process, 5 mL of 2.5% NaOCI was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. |
| Endoactivator Group | Experimental | Device: Root canal irrigationMedium Endoactivator tip of 25 / .04 size was used for irrigation activation. Medium type was placed in the canal 2 mm shorter than the working length and activation was performed by making short strokes of 2-3 mm. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy patients ranging between 18 and 60 years in age
- Patients that experienced moderate-to-severe pain represented on a visual analogue scale (VAS)
- Maxillar and Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis
Key exclusion criteria (10 listed)
- Any systemic disease and pregnancy in the patient
- Having used analgesic-anti-inflammatory in the last 12 hours and cortisone for the last 6 months
- The patient has bruxism
- Teeth with severe damage
- Teeth with calcified canals
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 irrigationAlso: EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-Devices used during root canal irrigation | Device | Conventional Syringe Irrigation Group, EDDY Group, Endoactivator Group, Xp Endo Finisher Group |
Primary outcome
Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial
Time frame: one week(7 days)
Preoperative pain of the patients before the treatment was recorded with the VAS scale. Pain levels were classified as 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain .After the treatment of the patients, a pain assessment form was given to the patient in order to evaluate the postoperative pain. Patients were asked to mark their pain levels on the VAS scale. The marking procedure was taught to the patients by a blinded researcher from the groups. When the patients came to the control appointment, VAS scales were collected and the data were analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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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.
yahya güven principal investigator
Afyonkarahisar Health Sciences University
Questions about this trial
What is this clinical trial studying?
A study testing Root canal irrigation in people with Endodontically Treated Teeth, run by Afyonkarahisar Health Sciences 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 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. 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 yahya güven (05314599583, yahyaguven52@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial (time frame: one week(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 15 Feb 2022.