Apical PeriodontitisNCT04486196
Effect of Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis
A study testing Medency Primo Diode Laser Device (Medency, Vicenza, Italy) and 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea), in people with Apical Periodontitis and Postoperative Pain, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode laser following chemomechanical root canal preparation on the severity of pain after root canal treatment (RCT). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Postoperative Pain
- What is being tested?
- Medency Primo Diode Laser Device (Medency, Vicenza, Italy) and 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2019to 20 Nov 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients
- Patients that had asymptomatic, single-rooted teeth with PAI score 3 or 4
Who cannot join
- antibiotic use with in the last month,
- anti-inflammatory analgesic use within the last five days,
- systemic disorder, pregnancy or lactation,
- traumatic occlusion,
- presence of other teeth requiring RCT,
- teeth with root canal fillings,
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- calcified canals,
- root resorption,
- periodontal diseases,
- sinus tracts
- severe crown destruction preventing rubber-dam application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Root Canal Disinfection With 980 µm Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis: A Randomized Clinical Trial
Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode laser following chemomechanical root canal preparation on the severity of pain after root canal treatment (RCT).
Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical index (PAI) score 3 or 4 were included. All patients were treated with two visits of root canal treatment including dressing with calcium hydroxide. Patients were randomly divided into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)': Root canals were irradiated with 980 µm diode laser after final irrigation at both visits. The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7 days. In addition, analgesic intake and time intervals were recorded by patients. The collected data were statistically analyzed with the Chi-square and Mann-Whitney U test (p<0.05).
- Conditions
- Apical Periodontitis, Postoperative Pain
- Being tested
- Medency Primo Diode Laser Device (Medency, Vicenza, Italy), 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),
- Keywords
- diode laser, irrigation, post-operative pain, root canal treatment, visual analog scale
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medency Primo Diode Laser Device (Medency, Vicenza, Italy)Device
Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle.
2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),Procedure or surgery
Final conventional irrigation
| Study group | Role | What they receive |
|---|---|---|
| Control (No Laser) Group | Experimental | The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water. Receives: Procedure: 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea), |
| Laser Disinfection (LD) Group | Experimental | After final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water, root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle. This cycle was applied 4 times for each root canal. The optical fiber (Medency) was inserted 1 mm short of the apex and the root canals were slowly (at a speed of 2mm/s) irradiated from apical to coronal in continuous circling movements to treat all dentinal tubules in one cycle for each power. Receives: Device: Medency Primo Diode Laser Device (Medency, Vicenza, Italy) |
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 will be assessed by visual analog scale (VAS).The pain levels will be evaluated after 8, 24, 48 hours and 7 days.
Measured: 7 days
Secondary outcomes (1)
Analgesic intake
After first and second appointments, analgesic use and time intervals will be 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 posted24 Jul 2020
- Study start8 Apr 2019
- Primary completion2 Nov 2019
- Study completion20 Nov 2019
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 Apical PeriodontitisStudies 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
- None (open label)
- Enrolment
- 60 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
- NCT04486196
- Sponsor's protocol ID
- BİRUNİ-BAP-01-01
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 24 Jul 2020
- 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, Sezgin GP, Sonmez Kaplan S. Effect of a 980-nm diode laser on post-operative pain after endodontic treatment in teeth with apical periodontitis: a randomized clinical trial. BMC Oral Health. 2021 Jan 22;21(1):41. doi: 10.1186/s12903-021-01401-w.
PubMed 33482797
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Root Canal Disinfection With 980 µm Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04486196
- Acronym / sponsor ID
- BİRUNİ-BAP-01-01
- Conditions
- Apical Periodontitis, Postoperative Pain
- Keywords
- diode laser, irrigation, post-operative pain, root canal treatment, visual analog scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 2 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 24 Jul 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.
Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode laser following chemomechanical root canal preparation on the severity of pain after root canal treatment (RCT).
Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical index (PAI) score 3 or 4 were included. All patients were treated with two visits of root canal treatment including dressing with calcium hydroxide. Patients were randomly divided into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)': Root canals were irradiated with 980 µm diode laser after final irrigation at both visits. The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7 days. In addition, analgesic intake and time intervals were recorded by patients. The collected data were statistically analyzed with the Chi-square and Mann-Whitney U test (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (No Laser) Group | Experimental | Procedure: 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water. |
| Laser Disinfection (LD) Group | Experimental | Device: Medency Primo Diode Laser Device (Medency, Vicenza, Italy)After final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water, root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle. This cycle was applied 4 times for each root canal. The optical fiber (Medency) was inserted 1 mm short of the apex and the root canals were slowly (at a speed of 2mm/s) irradiated from apical to coronal in continuous circling movements to treat all dentinal tubules in one cycle for each power. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy patients
- Patients that had asymptomatic, single-rooted teeth with PAI score 3 or 4
Key exclusion criteria (11 listed)
- antibiotic use with in the last month,
- anti-inflammatory analgesic use within the last five days,
- systemic disorder, pregnancy or lactation,
- traumatic occlusion,
- presence of other teeth requiring RCT,
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 |
|---|---|---|
| Medency Primo Diode Laser Device (Medency, Vicenza, Italy)Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle. | Device | Laser Disinfection (LD) Group |
| 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),Final conventional irrigation | Procedure or surgery | Control (No Laser) Group |
Primary outcome
Post-operative pain
Time frame: 7 days
Post-operative pain levels in each group will be assessed by visual analog scale (VAS).The pain levels will be evaluated after 8, 24, 48 hours and 7 days.
1 secondary outcome
Analgesic intake
Time frame: 7 days
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 24 Jul 2020.
- Derived from this study: PubMed 33482797Kaplan T, Sezgin GP, Sonmez Kaplan S. Effect of a 980-nm diode laser on post-operative pain after endodontic treatment in teeth with apical periodontitis: a randomized clinical trial. BMC Oral Health. 2021 Jan 22;21(1):41. doi: 10.1186/s12903-021-01401-w.
- 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 Medency Primo Diode Laser Device (Medency, Vicenza, Italy) and 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea), in people with Apical Periodontitis and Postoperative Pain, 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 2 inclusion and 11 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 24 Jul 2020. 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). 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 NCT04486196, 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 24 Jul 2020.