Postoperative PainNCT05479175
Evaluation the Effect of Using Preoperative Ibuprofen Versus Low Level Laser Therapy on Inferior Alveolar Nerve Block
A study testing Ibuprofen, Diode laser and Nonactive Diode laser in people with Postoperative Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Acute apical periodontitis (AAP) is an inflammatory condition of the periapical tissues of the periodontium, usually resulting from irreversible pulpitis and pulpal necrosis. Patients with AAP often have moderate to severe pain, which results in the need for emergency treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ibuprofen, Diode laser and Nonactive Diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Dec 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy persons between the ages of 18 and 50 years
- Mandibular molar teeth that were diagnosed with acute apical periodontitis
Who cannot join
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Trial locations and contacts
1 site in 1 country.
About this study
Acute apical periodontitis (AAP) is an inflammatory condition of the periapical tissues of the periodontium, usually resulting from irreversible pulpitis and pulpal necrosis. Patients with AAP often have moderate to severe pain, which results in the need for emergency treatment. Patients with AAP usually present with dull, throbbing, constant pain; absence of swelling; a negative or delayed positive result on vitality testing; absence of thermal sensitivity of the tooth; and pain on biting or percussion.The treatment of these teeth is root canal treatment. Pain control during root canal treatment is essential for several reasons. First, patients desire and expect that their treatment should be free of discomfort. Second, good intra-operative pain control helps to reduce post-operative pain and simplifies its management. Third, patients will be reluctant to have further root canal treatment in the future if they have had a bad experience as a result of pain during treatment. Hence, pain-free treatment should be every dentist's aim. The amount of pain experienced during treatment is related to the condition being treated teeth with irreversible pulpitis and acute apical periodontitis were significantly associated with more treatment pain than devital teeth and infected canals with apical periodontitis.In another study, molars and teeth with irreversible pulpitis had more intra-operative pain than single-rooted teeth and devital teeth, infected root canals. Local anesthesia is the most common method used for pain control during root canal treatment. However, other strategies can also be employed in some cases such as pre-treatment anti-inflammatory systemic medications, and methods to reduce discomfort associated with injections. The use of pre-operative medication reduce pain and inflammation at the treatment site. Several studies have been performed to investigate the effectiveness of this approach using a variety of drugs such as benzodiazepines, NSAIDs and corticosteroids. The concept of using NSAIDs and corticosteroids as premedication is largely based on reducing the amount of prostaglandin in the inflamed pulp. There have been conflicting results reported for the use of ibuprofen premedication with some studies reporting an increased success rate for local anaesthesia,while others have reported no effects compared with placebo.
Recently, low level laser therapy has been used in dentistry for a range of treatments, including reduction of orthodontic pain, symptomatic oral lichen planus cases, healing of maxillofacial defects and prophylaxis of stomatitis. LLLT has begun to be used in endodontic treatments due to its ability to increase wound healing, its role in root canal disinfection, its role in reducing pain and its very limited side effects. However, the pain reduction mechanism of LLLT is not fully understood.
Read the detailed description
The study is to be carried out in 76 medically free patients, aged 18-50 years, who were diagnosed in Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Endodontic, The number of patient was calculated in the G* Power 3.1 software. In this study cohen criteria was used. Taking effect size 0.40, alpha = 0.05, and power = 0.80, the minimum number of patients was determined as 76.
Lower first and second molars (36,37,46,47) diagnosed with acute apical periodontitis will be included in the study as an experimental group. Patients with periapical lesions and open apex teeth will not be included in the study group. Preoperative pain degree will be determined using Visual analogue scale (VAS) test. Patients will be randomly divided into 4 groups.
Group 1: Ibuprofen 600mg will be given to the patient one hour before starting root canal treatment Group 2: Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds .
Group 3: Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated.
Group 4: Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure.
After applying 2 ml ultracain DS forte local anesthesia access cavity will be opened. The working length will be determined using the apex locator by placing a K file #15 into the root canals until the apical constriction. The shaping process of the root canals will be done by ProTaperNext files up to the X3 as standard in all patients. 2 ml of 5.25% NaOCl irrigation solution will be applied after each file. A 2 ml dental injector with a 27 gauge dental needle will be used and The tip of the needles will be adjusted to be 2mm shorter than the working length. After complete the cleaning and shaping process, the root canals will be filled with gutta-percha and ADSEAL resin sealer using the lateral condensation technique. After complete the root canal treatment, the level of pain experienced by the patients during the treatment will be determined using the visual analogue scale (VAS) test.
- Conditions
- Postoperative Pain
- Being tested
- Ibuprofen, Diode laser, Nonactive Diode laser
- Keywords
- Root canal, anesthesia, inferior alveolar nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Ibuprofen
Diode laserDevice
Diode laser
Nonactive Diode laserDevice
Nonactive Diode laser
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Ibuprofen 600 mg will be given to the patient one hour before starting root canal treatment. Receives: Drug: Ibuprofen |
| Diode laser | Active comparator | Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds. Receives: Device: Diode laser |
| Nonactive Diode laser | Active comparator | Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated. Receives: Device: Nonactive Diode laser |
| Control | No intervention | Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Scale
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 May 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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 Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Ibuprofen 600 mg will be given to the patient one hour before starting root canal treatment. Group 2: Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds. Group 3: Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated. Group 4: Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Özlek, Yuzuncu Yil University
- Investigators
- Esin Özlek, PhD, Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479175
- Sponsor's protocol ID
- 12/15.12.2021
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
PubMed 21692235
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Using Preoperative Ibuprofen Versus Low Level Laser Therapy on Inferior Alveolar Nerve Block
- ClinicalTrials.gov ID
- NCT05479175
- Acronym / sponsor ID
- 12/15.12.2021
- Conditions
- Postoperative Pain
- Keywords
- Root canal, anesthesia, inferior alveolar nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 29 Jul 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.
Acute apical periodontitis (AAP) is an inflammatory condition of the periapical tissues of the periodontium, usually resulting from irreversible pulpitis and pulpal necrosis. Patients with AAP often have moderate to severe pain, which results in the need for emergency treatment. Patients with AAP usually present with dull, throbbing, constant pain; absence of swelling; a negative or delayed positive result on vitality testing; absence of thermal sensitivity of the tooth; and pain on biting or percussion.The treatment of these teeth is root canal treatment. Pain control during root canal treatment is essential for several reasons. First, patients desire and expect that their treatment should be free of discomfort. Second, good intra-operative pain control helps to reduce post-operative pain and simplifies its management. Third, patients will be reluctant to have further root canal treatment in the future if they have had a bad experience as a result of pain during treatment. Hence, pain-free treatment should be every dentist's aim. The amount of pain experienced during treatment is related to the condition being treated teeth with irreversible pulpitis and acute apical periodontitis were significantly associated with more treatment pain than devital teeth and infected canals with apical periodontitis.In another study, molars and teeth with irreversible pulpitis had more intra-operative pain than single-rooted teeth and devital teeth, infected root canals. Local anesthesia is the most common method used for pain control during root canal treatment. However, other strategies can also be employed in some cases such as pre-treatment anti-inflammatory systemic medications, and methods to reduce discomfort associated with injections. The use of pre-operative medication reduce pain and inflammation at the treatment site. Several studies have been performed to investigate the effectiveness of this approach using a variety of drugs such as benzodiazepines, NSAIDs and corticosteroids. The concept of using NSAIDs and corticosteroids as premedication is largely based on reducing the amount of prostaglandin in the inflamed pulp. There have been conflicting results reported for the use of ibuprofen premedication with some studies reporting an increased success rate for local anaesthesia,while others have reported no effects compared with placebo.
Recently, low level laser therapy has been used in dentistry for a range of treatments, including reduction of orthodontic pain, symptomatic oral lichen planus cases, healing of maxillofacial defects and prophylaxis of stomatitis. LLLT has begun to be used in endodontic treatments due to its ability to increase wound healing, its role in root canal disinfection, its role in reducing pain and its very limited side effects. However, the pain reduction mechanism of LLLT is not fully understood.
Detailed description
The study is to be carried out in 76 medically free patients, aged 18-50 years, who were diagnosed in Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Endodontic, The number of patient was calculated in the G* Power 3.1 software. In this study cohen criteria was used. Taking effect size 0.40, alpha = 0.05, and power = 0.80, the minimum number of patients was determined as 76.
Lower first and second molars (36,37,46,47) diagnosed with acute apical periodontitis will be included in the study as an experimental group. Patients with periapical lesions and open apex teeth will not be included in the study group. Preoperative pain degree will be determined using Visual analogue scale (VAS) test. Patients will be randomly divided into 4 groups.
Group 1: Ibuprofen 600mg will be given to the patient one hour before starting root canal treatment Group 2: Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds .
Group 3: Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated.
Group 4: Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure.
After applying 2 ml ultracain DS forte local anesthesia access cavity will be opened. The working length will be determined using the apex locator by placing a K file #15 into the root canals until the apical constriction. The shaping process of the root canals will be done by ProTaperNext files up to the X3 as standard in all patients. 2 ml of 5.25% NaOCl irrigation solution will be applied after each file. A 2 ml dental injector with a 27 gauge dental needle will be used and The tip of the needles will be adjusted to be 2mm shorter than the working length. After complete the cleaning and shaping process, the root canals will be filled with gutta-percha and ADSEAL resin sealer using the lateral condensation technique. After complete the root canal treatment, the level of pain experienced by the patients during the treatment will be determined using the visual analogue scale (VAS) test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Group 1: Ibuprofen 600 mg will be given to the patient one hour before starting root canal treatment. Group 2: Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds. Group 3: Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated. Group 4: Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure.
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen 600 mg will be given to the patient one hour before starting root canal treatment. |
| Diode laser | Active comparator | Device: Diode laserLow-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds. |
| Nonactive Diode laser | Active comparator | Device: Nonactive Diode laserPlacebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated. |
| Control | No intervention | –Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy persons between the ages of 18 and 50 years
- Mandibular molar teeth that were diagnosed with acute apical periodontitis
Key exclusion criteria (7 listed)
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
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 |
|---|---|---|
| IbuprofenIbuprofen | Drug | Ibuprofen |
| Diode laserDiode laser | Device | Diode laser |
| Nonactive Diode laserNonactive Diode laser | Device | Nonactive Diode laser |
Primary outcome
VAS Scale
Time frame: up to 2 hours
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 21692235Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
- 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.
Esin Özlek, PhD study director
Yuzuncu Yil 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 Ibuprofen, Diode laser and Nonactive Diode laser in people with Postoperative Pain, run by Yuzuncu Yil 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 7 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 29 Jul 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?
Results are not available in the source record.
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?
VAS Scale (time frame: up to 2 hours). 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 NCT05479175, 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 29 Jul 2022.