Post Operative PainNCT04197531
Postoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth
A study testing Irrigation Method in people with Post Operative Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was to evaluate and compare the postoperative pain levels after using EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary molars. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Irrigation Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 30 Apr 2019
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients exhibiting positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the Frankl's scale)
- American Society of Anesthesiologists class 1 patients aged 5-9 years
- Patients with symptomatic irreversible pulpitis of maxillary primary molars confirmed using periapical radiographs, percussion, and cold test
- Patients having teeth with two-thirds of each root remaining
- Absence of periapical lesions and interradicular radiolucency
- Moderate to very severe (2-4) five-face scale pain scores in the 24-hour period before the procedure.
Who cannot join
- Patients who had taken analgesics and antibiotics within the last 12 hours before root canal treatment
- Teeth with pathologic root resorption
- Teeth with excessive mobility.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University, Faculty of Dentistry
Kayseri, 38039
About this study
Official title: A Comparative Evaluation of the Effect of EndoActivator and Endodontic Syringe Usage on Postoperative Pain in Root Canal Irrigations in Primary Molar Teeth: A Randomized Clinical Study
This study was to evaluate and compare the postoperative pain levels after using EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary molars.
- Conditions
- Post Operative Pain
- Being tested
- Irrigation Method
- Keywords
- EndoActivator, Irrigation, Postoperative pain, Primary teeth
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation MethodOther
Irrigation Method
| Study group | Role | What they receive |
|---|---|---|
| EndoActivator | Experimental | Not described Receives: Other: Irrigation Method |
| Conventional Endodontic Syringe | Experimental | Not described Receives: Other: Irrigation Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
Measured: 8th hours
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
Measured: 24th hours
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
Measured: 48th hours
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
Measured: 72th hours
Secondary outcomes (4)
Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours.
The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".
Measured: 0-8 hours
Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours.
The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".
Measured: 8-24 hours
Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours.
The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".
Measured: 24-48 hours
Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours.
The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Apr 2018
- Primary completion1 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husniye Gumus, TC Erciyes University
- Investigators
- Hüsniye Gümüş, PHD., Dr., Study director, Erciyes University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197531
- Sponsor's protocol ID
- 2018/152
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4.
PubMed 25195661Yilmaz K, Tufenkci P, Adiguzel M. The effects of QMix and EndoActivator on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Clin Oral Investig. 2019 Nov;23(11):4173-4180. doi: 10.1007/s00784-019-02856-6. Epub 2019 Feb 27.
PubMed 30815731Gumus H, Delikan E. The effect of sonic activation of irrigant on postoperative pain after root canal treatment in primary molar teeth: a randomized, clinical study. Clin Oral Investig. 2021 Jan;25(1):363-370. doi: 10.1007/s00784-020-03687-6. Epub 2020 Nov 12.
PubMed 33184717
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Effect of EndoActivator and Endodontic Syringe Usage on Postoperative Pain in Root Canal Irrigations in Primary Molar Teeth: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04197531
- Acronym / sponsor ID
- 2018/152
- Conditions
- Post Operative Pain
- Keywords
- EndoActivator, Irrigation, Postoperative pain, Primary teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Dec 2019 (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 to evaluate and compare the postoperative pain levels after using EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoActivator | Experimental | Other: Irrigation Method |
| Conventional Endodontic Syringe | Experimental | Other: Irrigation Method |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients exhibiting positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the Frankl's scale)
- American Society of Anesthesiologists class 1 patients aged 5-9 years
- Patients with symptomatic irreversible pulpitis of maxillary primary molars confirmed using periapical radiographs, percussion, and cold test
- Patients having teeth with two-thirds of each root remaining
- Absence of periapical lesions and interradicular radiolucency
Key exclusion criteria (3 listed)
- Patients who had taken analgesics and antibiotics within the last 12 hours before root canal treatment
- Teeth with pathologic root resorption
- Teeth with excessive mobility.
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 |
|---|---|---|
| Irrigation MethodIrrigation Method | Other | Conventional Endodontic Syringe, EndoActivator |
Primary outcome
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours
Time frame: 8th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours
Time frame: 24th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours
Time frame: 48th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours
Time frame: 72th hours
Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.
4 secondary outcomes
Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours.
Time frame: 0-8 hours
Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours.
Time frame: 8-24 hours
Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours.
Time frame: 24-48 hours
Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours.
Time frame: 48-72 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 17 Dec 2019.
- Background: PubMed 25195661Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4.
- Background: PubMed 30815731Yilmaz K, Tufenkci P, Adiguzel M. The effects of QMix and EndoActivator on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Clin Oral Investig. 2019 Nov;23(11):4173-4180. doi: 10.1007/s00784-019-02856-6. Epub 2019 Feb 27.
- Derived from this study: PubMed 33184717Gumus H, Delikan E. The effect of sonic activation of irrigant on postoperative pain after root canal treatment in primary molar teeth: a randomized, clinical study. Clin Oral Investig. 2021 Jan;25(1):363-370. doi: 10.1007/s00784-020-03687-6. Epub 2020 Nov 12.
- 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.
Hüsniye Gümüş, PHD., Dr. study director
Erciyes University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation Method in people with Post Operative Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 17 Dec 2019. 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 Turkey (Türkiye). 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?
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours (time frame: 8th hours). 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?
On the ClinicalTrials.gov record for NCT04197531, which also lists 3 linked publications.
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 17 Dec 2019.