Post-operative PainPPNCT05195021
The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP)
A study testing EDDY, Diode Laser device and Conventional irrigation in people with Post-operative Pain and Apical Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to examine post-operative pain (PP) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Apical Periodontitis
- What is being tested?
- EDDY, Diode Laser device and Conventional irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 30 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult patients aged between 18 and 65 years
- Moderate to severe pain (4-10) according to a visual analogue scale (VAS)
- Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation)
Who cannot join
- Pregnancy or lactation
- Taking analgesics or anti-inflammatory drugs 12 hours before the treatment
- Taking antibiotics in the month prior to the treatment
- Teeth with calcified root canals, greater than grade I mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex
- Allergy to articaine or non-steroid anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain in Mandibular Molars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
Aim: The aim of this study was to examine post-operative pain (PP) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis.
Methods: In total, 80 patients with symptomatic apical periodontitis were included in this randomized clinical study. There were four different irrigation and disinfection groups. In group 1, conventional irrigation only was applied. In group 2, EDDY (VDW, Munich, Germany), a sonic irrigation activation system, was applied. In groups 3 and 4, irradiation with a 980-nm diode laser was performed, following irrigation with the conventional method (needle irrigation) and EDDY (VDW) irrigation system, respectively. PP was assessed using a visual analogue scale (VAS). The patients were instructed to record their PP using this scale 8, 24, 48 hours and 7 days post-procedure, in addition to their analgesic intake. A chi-square test, Fisher's exact chi-square test and Fisher-Freeman-Halton exact test were used to assess qualitative data. Inter-group and intra-group parameters were assessed using the Kruskal-Wallis test and Wilcoxon's test at a significance level of p < 0.05 (for both).
- Conditions
- Post-operative Pain, Apical Periodontitis
- Being tested
- EDDY, Diode Laser device, Conventional irrigation
- Keywords
- diode laser, EDDY, post-operative pain, sypmtomatic apical periodontitis
- Medical subject headings
- Pain, Postoperative, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDDYDevice
Also called EDDY (VDW, Munich, Germany)
EDDY (VDW) sonic irrigation activation system
Diode Laser deviceDevice
Also called Medency Primo 10 W Diode Laser, Vicenza, Italy
980-nm diode laser device
Conventional irrigationDevice
Also called 31-guage side port needle (NaviTip; Ultradent, South Jordan, UT)
Conventional root canal irrigation with 31-guage side port needle
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (conventional irrigation) | Experimental | After finishing the mechanical instrumentation, each root canal was irrigated with 5 ml of 5.25% NaOCl using a 31-gauge needle positioned 2 mm shorter than the WL. To remove the smear layer, 5 ml of 17% ethylenediaminetetraacetic acid (EDTA) was used in each canal for 1 minute, and 5 ml of saline was then administered to neutralize all the residues. Receives: Device: Conventional irrigation |
| Group 2 (EDDY) | Experimental | In group 2, 1 ml of 5.25% NaOCl was agitated for 20 seconds three times with the EDDY tip positioned 2 mm shorter than the WL. The root canals were then irrigated with 2 ml of 5.25% NaOCl again. Subsequently, the EDDY tip was activated with short pumping movements, and 2 ml of 17% EDTA was activated for 30 seconds, as described above. The final irrigation followed the same procedures as in group 1. Receives: Device: EDDY; Device: Conventional irrigation |
| Group 3 (conventional irrigation and laser irradiation) | Experimental | In group 3, final irrigation followed the same procedures as in group 1 and group 2. During the laser therapy, both the operator and the patient wore eyewear for protection. Laser irradiation was performed using a 980-nm diode laser (Medency Primo 10 W Diode Laser; Vicenza, Italy), coupled with optical fibre (200 µm). The settings were as follows: average power of 1.2 W with a low frequency of 50 Hz and energy of 12 J (each cycle) in pulsed mode, irradiation for 10 seconds, followed by a 10 second pause, which constituted one cycle. This cycle was applied four times to each root canal. The optical fibre tip was located at the WL. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to the coronal portion using a continuous helicoidal movement, with optical fibre tip contacting the root canal walls in one cycle for each power. Receives: Device: Diode Laser device; Device: Conventional irrigation |
| Group 4 (EDDY and laser irradiation) | Experimental | In this group, after agitation using the EDDY (VDW) system was performed using the same procedures as in group 3, final irrigation and laser irradiation were done as in group 2. Receives: Device: EDDY; Device: Diode Laser device; Device: Conventional irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain levels in each group were assessed by visual analog scale (VAS) The pain levels were evaluated at 8, 24, 48 hours and 7 days post-procedure
Measured: 7 days
Anaglesic intake
After the operation nalgesic intake and time intervals were recorded
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 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 Post-operative PainStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Sönmez Kaplan, Biruni University
- Investigators
- Sema Sönmez Kaplan, DDS, PhD, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195021
- Sponsor's protocol ID
- BİRUNİ-BAP-2020-01-47
- Acronym
- PP
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided which collected IPD or which IPD that underlie results to share in a publication.
Publications
Kaplan T, Kaplan SS, Sezgin GP. The effect of different irrigation and disinfection methods on post-operative pain in mandibular molars: a randomised clinical trial. BMC Oral Health. 2022 Dec 13;22(1):601. doi: 10.1186/s12903-022-02651-y.
PubMed 36514017
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain in Mandibular Molars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05195021
- Acronym / sponsor ID
- PP / BİRUNİ-BAP-2020-01-47
- Conditions
- Post-operative Pain, Apical Periodontitis
- Keywords
- diode laser, EDDY, post-operative pain, sypmtomatic apical periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 18 Jan 2022 (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 was to examine post-operative pain (PP) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis.
Methods: In total, 80 patients with symptomatic apical periodontitis were included in this randomized clinical study. There were four different irrigation and disinfection groups. In group 1, conventional irrigation only was applied. In group 2, EDDY (VDW, Munich, Germany), a sonic irrigation activation system, was applied. In groups 3 and 4, irradiation with a 980-nm diode laser was performed, following irrigation with the conventional method (needle irrigation) and EDDY (VDW) irrigation system, respectively. PP was assessed using a visual analogue scale (VAS). The patients were instructed to record their PP using this scale 8, 24, 48 hours and 7 days post-procedure, in addition to their analgesic intake. A chi-square test, Fisher's exact chi-square test and Fisher-Freeman-Halton exact test were used to assess qualitative data. Inter-group and intra-group parameters were assessed using the Kruskal-Wallis test and Wilcoxon's test at a significance level of p < 0.05 (for both).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (conventional irrigation) | Experimental | Device: Conventional irrigationAfter finishing the mechanical instrumentation, each root canal was irrigated with 5 ml of 5.25% NaOCl using a 31-gauge needle positioned 2 mm shorter than the WL. To remove the smear layer, 5 ml of 17% ethylenediaminetetraacetic acid (EDTA) was used in each canal for 1 minute, and 5 ml of saline was then administered to neutralize all the residues. |
| Group 2 (EDDY) | Experimental | Device: EDDY, Device: Conventional irrigationIn group 2, 1 ml of 5.25% NaOCl was agitated for 20 seconds three times with the EDDY tip positioned 2 mm shorter than the WL. The root canals were then irrigated with 2 ml of 5.25% NaOCl again. Subsequently, the EDDY tip was activated with short pumping movements, and 2 ml of 17% EDTA was activated for 30 seconds, as described above. The final irrigation followed the same procedures as in group 1. |
| Group 3 (conventional irrigation and laser irradiation) | Experimental | Device: Diode Laser device, Device: Conventional irrigationIn group 3, final irrigation followed the same procedures as in group 1 and group 2. During the laser therapy, both the operator and the patient wore eyewear for protection. Laser irradiation was performed using a 980-nm diode laser (Medency Primo 10 W Diode Laser; Vicenza, Italy), coupled with optical fibre (200 µm). The settings were as follows: average power of 1.2 W with a low frequency of 50 Hz and energy of 12 J (each cycle) in pulsed mode, irradiation for 10 seconds, followed by a 10 second pause, which constituted one cycle. This cycle was applied four times to each root canal. The optical fibre tip was located at the WL. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to the coronal portion using a continuous helicoidal movement, with optical fibre tip contacting the root canal walls in one cycle for each power. |
| Group 4 (EDDY and laser irradiation) | Experimental | Device: EDDY, Device: Diode Laser device, Device: Conventional irrigationIn this group, after agitation using the EDDY (VDW) system was performed using the same procedures as in group 3, final irrigation and laser irradiation were done as in group 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult patients aged between 18 and 65 years
- Moderate to severe pain (4-10) according to a visual analogue scale (VAS)
- Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation)
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Taking analgesics or anti-inflammatory drugs 12 hours before the treatment
- Taking antibiotics in the month prior to the treatment
- Teeth with calcified root canals, greater than grade I mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex
- Allergy to articaine or non-steroid anti-inflammatory drugs
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 |
|---|---|---|
| EDDYAlso: EDDY (VDW, Munich, Germany)EDDY (VDW) sonic irrigation activation system | Device | Group 2 (EDDY), Group 4 (EDDY and laser irradiation) |
| Diode Laser deviceAlso: Medency Primo 10 W Diode Laser, Vicenza, Italy980-nm diode laser device | Device | Group 3 (conventional irrigation and laser irradiation), Group 4 (EDDY and laser irradiation) |
| Conventional irrigationAlso: 31-guage side port needle (NaviTip; Ultradent, South Jordan, UT)Conventional root canal irrigation with 31-guage side port needle | Device | Group 1 (conventional irrigation), Group 2 (EDDY), Group 3 (conventional irrigation and laser irradiation), Group 4 (EDDY and laser irradiation) |
Primary outcome
Post-operative pain
Time frame: 7 days
Post-operative pain levels in each group were assessed by visual analog scale (VAS) The pain levels were evaluated at 8, 24, 48 hours and 7 days post-procedure
Anaglesic intake
Time frame: 7 days
After the operation nalgesic intake and time intervals were recorded
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 18 Jan 2022.
- Derived from this study: PubMed 36514017Kaplan T, Kaplan SS, Sezgin GP. The effect of different irrigation and disinfection methods on post-operative pain in mandibular molars: a randomised clinical trial. BMC Oral Health. 2022 Dec 13;22(1):601. doi: 10.1186/s12903-022-02651-y.
- Individual participant dataSharing planned: Undecided. Not decided which collected IPD or which IPD that underlie results to share in a publication.
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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.
Sema Sönmez Kaplan, DDS, PhD principal investigator
Biruni 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 EDDY, Diode Laser device and Conventional irrigation in people with Post-operative Pain and Apical Periodontitis, run by Biruni 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 3 inclusion and 5 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 18 Jan 2022. 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?
Post-operative pain (time frame: 7 days). 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 NCT05195021, 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 18 Jan 2022.