Postoperative PainNCT03783520
Postoperative Pain After Using Er,Cr,YSGG Lazer Irradiation During Root Canal Treatment
A study testing Er,Cr:YSGG Laser and Sodium hypochlorite in people with Postoperative Pain, run by Cukurova University.
Trial summary
Irrigation with sodium hypochlorite (NaOCl) during chemo-mechanic preparation for effective root canal disinfection is a standard protocol in root canal treatment. NaOCl is an alkali irrigant with pH 11.0 -12.0. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Er,Cr:YSGG Laser and Sodium hypochlorite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- 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
- 1)Single-rooted, maxillary and mandibular incisors, canines or premolars that were asymptomatic (no preoperative pain, swelling or acute endodontic or periodontal abscess). 2)Nonvital pulps and did not respond to cold testing.
- 3)People had no systemic diseases or allergies to local anesthetic agents . 4)People had not received any endodontic treatment previously. 5)People had no radiographic evidence of periapical bone loss.
Who cannot join
- Pregnant and breastfeeding women
- Patients taking analgesic, anti-inflammatory, or antibiotic medications during seven days prior to beginning of treatment.
About this study
Official title: Postoperative Pain After Using Er,Cr: YSGG Laser Irradiation Versus NaOCl Irrigation: A Randomized Controlled Clinical Trial
Irrigation with sodium hypochlorite (NaOCl) during chemo-mechanic preparation for effective root canal disinfection is a standard protocol in root canal treatment. NaOCl is an alkali irrigant with pH 11.0 -12.0. Nearby its high antimicrobial efficacy, cytotoxic features make it questionable when it comes contact with periradicular tissues. Several irrigation materials were investigated less cytotoxic, more or equal antimicrobial to avoid such adverse effects. Calcium hypochlorite, chlorhexidine, chitosan and antibiotics are some of the chemicals tested. Laser is not a chemical but its action may show antibacterial effect. Studies showed that Er,Cr:YSGG laser is strongly antibacterial against Enterococcus faecalis biofilm. This antibacterial effect were frequently obtained with laser activated irrigation (LAI) or photon-induced photoacoustic streaming (PIPS) in the literature. The aim of this study was to evaluate whether disinfection procedure with laser provides more or less benefit in terms of postoperative pain when compared with the conventional NaOCl irrigation method.
Read the detailed description
Both for maxillary and mandibular teeth, infiltration anesthesia were achieved by local anesthetic with 2 ml articaine hydrochloride with 1:200000 epinephrine (Maxicaine, VEM İlaç, Ist, Turkey). Endodontic access preparations were performed using diamond round burs. After the canals became visible, patency was checked with a K hand file (VDW, Munich, Germany), and a rubber dam was placed for isolation. The working length (WL) was determined with an electronic apex locator (Raypex 6, VDW) and accepted when three green bars were reached.
A crown-down preparation technique was performed using Reciproc nickel-titanium instruments (VDW, Munich, Germany) R#50 according to the manufacturers' instruction until the WL. During the instrumentation procedures, the root canals were irrigated with 6 ml of 2,5% NaOCl between each file.
In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation.
In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL.
At the end of disinfection procedures, each root canal was dried with paper points and the largest gutta-percha cone that reached the WL without any resistance was used as the master cone. Measurements from the electronic apex locator were confirmed radiographically. In cases of discrepancies between the radiographic and electronic measurements, the latter was selected. All root canals were filled with gutta-percha and root canal sealer (Adseal Meta Biomed Co, Korea) using the lateral condensation technique. The teeth were coronally sealed with composite resin (Premise, Kerr, Salerno, Italy). After the completion of the root fillings, postoperative instructions were given to all patients and prescribed 200 mg ibuprofen only one tablet if it is needed within the 0- to 6-hour time interval after the treatment and then one for every 8 hours in the event of pain.
- Conditions
- Postoperative Pain
- Being tested
- Er,Cr:YSGG Laser, Sodium hypochlorite
- Keywords
- root canal treatment, intracanal irrigation, Laser
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er,Cr:YSGG LaserDevice
Er,Cr:YSGG Laser is used for disinfection of the root canals.
Sodium hypochloriteOther
Sodium hypochlorite is used for disinfection of the root canals
| Study group | Role | What they receive |
|---|---|---|
| Er,Cr:YSGG Laser | Experimental | In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation. Receives: Device: Er,Cr:YSGG Laser |
| Sodium hypochlorite | Active comparator | In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL. Receives: Other: Sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Postoperative pain
Postoperative pain evaluation with verbal analog scale after root canal treatment. Patients signed as 0: no pain; 1: mild pain, analgesic not required; 2: moderate pain, analgesic required; 3: severe pain, analgesic has no effect in relieving the pain. The data were collected and statistically analysed using by the numerical data. In this study, "0" and "1" scores are considered as better outcome. Patients who signed these scores didn't need to use analgesics. The worst outcome is considered as the patients signed "3". Each scale range for each time interval evaluated as count of patient and presented as percentage. Scale ranges are not summed.
Measured: 0-24 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Görkem Özbilen, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783520
- Sponsor's protocol ID
- Cukurova Endodontics
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.
PubMed 23402273Dewsnup N, Pileggi R, Haddix J, Nair U, Walker C, Varella CH. Comparison of bacterial reduction in straight and curved canals using erbium, chromium:yttrium-scandium-gallium-garnet laser treatment versus a traditional irrigation technique with sodium hypochlorite. J Endod. 2010 Apr;36(4):725-8. doi: 10.1016/j.joen.2009.11.017. Epub 2010 Feb 6.
PubMed 20307752Figini L, Lodi G, Gorni F, Gagliani M. Single versus multiple visits for endodontic treatment of permanent teeth: a Cochrane systematic review. J Endod. 2008 Sep;34(9):1041-7. doi: 10.1016/j.joen.2008.06.009.
PubMed 18718362Christo JE, Zilm PS, Sullivan T, Cathro PR. Efficacy of low concentrations of sodium hypochlorite and low-powered Er,Cr:YSGG laser activated irrigation against an Enterococcus faecalis biofilm. Int Endod J. 2016 Mar;49(3):279-86. doi: 10.1111/iej.12447. Epub 2015 Apr 1.
PubMed 25772335
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Using Er,Cr: YSGG Laser Irradiation Versus NaOCl Irrigation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03783520
- Acronym / sponsor ID
- Cukurova Endodontics
- Conditions
- Postoperative Pain
- Keywords
- root canal treatment, intracanal irrigation, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Dec 2018 (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.
Irrigation with sodium hypochlorite (NaOCl) during chemo-mechanic preparation for effective root canal disinfection is a standard protocol in root canal treatment. NaOCl is an alkali irrigant with pH 11.0 -12.0. Nearby its high antimicrobial efficacy, cytotoxic features make it questionable when it comes contact with periradicular tissues. Several irrigation materials were investigated less cytotoxic, more or equal antimicrobial to avoid such adverse effects. Calcium hypochlorite, chlorhexidine, chitosan and antibiotics are some of the chemicals tested. Laser is not a chemical but its action may show antibacterial effect. Studies showed that Er,Cr:YSGG laser is strongly antibacterial against Enterococcus faecalis biofilm. This antibacterial effect were frequently obtained with laser activated irrigation (LAI) or photon-induced photoacoustic streaming (PIPS) in the literature. The aim of this study was to evaluate whether disinfection procedure with laser provides more or less benefit in terms of postoperative pain when compared with the conventional NaOCl irrigation method.
Detailed description
Both for maxillary and mandibular teeth, infiltration anesthesia were achieved by local anesthetic with 2 ml articaine hydrochloride with 1:200000 epinephrine (Maxicaine, VEM İlaç, Ist, Turkey). Endodontic access preparations were performed using diamond round burs. After the canals became visible, patency was checked with a K hand file (VDW, Munich, Germany), and a rubber dam was placed for isolation. The working length (WL) was determined with an electronic apex locator (Raypex 6, VDW) and accepted when three green bars were reached.
A crown-down preparation technique was performed using Reciproc nickel-titanium instruments (VDW, Munich, Germany) R#50 according to the manufacturers' instruction until the WL. During the instrumentation procedures, the root canals were irrigated with 6 ml of 2,5% NaOCl between each file.
In laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation.
In control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL.
At the end of disinfection procedures, each root canal was dried with paper points and the largest gutta-percha cone that reached the WL without any resistance was used as the master cone. Measurements from the electronic apex locator were confirmed radiographically. In cases of discrepancies between the radiographic and electronic measurements, the latter was selected. All root canals were filled with gutta-percha and root canal sealer (Adseal Meta Biomed Co, Korea) using the lateral condensation technique. The teeth were coronally sealed with composite resin (Premise, Kerr, Salerno, Italy). After the completion of the root fillings, postoperative instructions were given to all patients and prescribed 200 mg ibuprofen only one tablet if it is needed within the 0- to 6-hour time interval after the treatment and then one for every 8 hours in the event of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Er,Cr:YSGG Laser | Experimental | Device: Er,Cr:YSGG LaserIn laser group, each root canal was dried with paper points and then Er,Cr:YSGG (Biolase™, Waterlase™, San Clemente, CA, USA) was used for intracanal disinfection with the following parameters: panel output power of 0,75 W, pulse frequency of 20 Hz, and 1% water pressure to 10% air pressure ratio laser with RFT3 tips (415 µm diameter radial firing tip RFT3 Endolase, Biolase Technology, Inc; calibration factor of 0.85). The fiber was placed at 1mm short of the WL. Irradiation was delivered along the entire length of the root canal with helicoradial movements, 1mm per seconds in speed. This procedure was repeated three times and kept for 20 seconds between each irradiation. |
| Sodium hypochlorite | Active comparator | Other: Sodium hypochloriteIn control group, each canal were irrigated with 6 ml of 2,5% NaOCl. For the final irrigation, 5 ml of sterile saline were used. During irrigation, needle was inserted 1 mm short of the WL. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1)Single-rooted, maxillary and mandibular incisors, canines or premolars that were asymptomatic (no preoperative pain, swelling or acute endodontic or periodontal abscess). 2)Nonvital pulps and did not respond to cold testing.
- 3)People had no systemic diseases or allergies to local anesthetic agents . 4)People had not received any endodontic treatment previously. 5)People had no radiographic evidence of periapical bone loss.
Key exclusion criteria (2 listed)
- Pregnant and breastfeeding women
- Patients taking analgesic, anti-inflammatory, or antibiotic medications during seven days prior to beginning of treatment.
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 |
|---|---|---|
| Er,Cr:YSGG LaserEr,Cr:YSGG Laser is used for disinfection of the root canals. | Device | Er,Cr:YSGG Laser |
| Sodium hypochloriteSodium hypochlorite is used for disinfection of the root canals | Other | Sodium hypochlorite |
Primary outcome
Evaluation of Postoperative pain
Time frame: 0-24 hours after root canal treatment
Postoperative pain evaluation with verbal analog scale after root canal treatment. Patients signed as 0: no pain; 1: mild pain, analgesic not required; 2: moderate pain, analgesic required; 3: severe pain, analgesic has no effect in relieving the pain. The data were collected and statistically analysed using by the numerical data. In this study, "0" and "1" scores are considered as better outcome. Patients who signed these scores didn't need to use analgesics. The worst outcome is considered as the patients signed "3". Each scale range for each time interval evaluated as count of patient and presented as percentage. Scale ranges are not summed.
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 21 Jul 2020.
- Background: PubMed 23402273Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.
- Background: PubMed 20307752Dewsnup N, Pileggi R, Haddix J, Nair U, Walker C, Varella CH. Comparison of bacterial reduction in straight and curved canals using erbium, chromium:yttrium-scandium-gallium-garnet laser treatment versus a traditional irrigation technique with sodium hypochlorite. J Endod. 2010 Apr;36(4):725-8. doi: 10.1016/j.joen.2009.11.017. Epub 2010 Feb 6.
- Background: PubMed 18718362Figini L, Lodi G, Gorni F, Gagliani M. Single versus multiple visits for endodontic treatment of permanent teeth: a Cochrane systematic review. J Endod. 2008 Sep;34(9):1041-7. doi: 10.1016/j.joen.2008.06.009.
- Background: PubMed 25772335Christo JE, Zilm PS, Sullivan T, Cathro PR. Efficacy of low concentrations of sodium hypochlorite and low-powered Er,Cr:YSGG laser activated irrigation against an Enterococcus faecalis biofilm. Int Endod J. 2016 Mar;49(3):279-86. doi: 10.1111/iej.12447. Epub 2015 Apr 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Er,Cr:YSGG Laser and Sodium hypochlorite in people with Postoperative Pain, run by Cukurova 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 2 inclusion and 2 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 21 Jul 2020. 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?
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?
Evaluation of Postoperative pain (time frame: 0-24 hours after root canal treatment). 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 NCT03783520, which also lists 4 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 21 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.