PulpitisNCT02169102
Effect of Low Power Laser in Tooth Pain Modulation Caused by Irreversible Inflammation
A study testing Laser 1 (at 0,16 Joules/point of irradiation) and Laser 2 (1,6 Joules/point of irradiation) in people with Pulpitis and Acute Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Anxiety, pain and discomfort are common stressful situations that occur during the dentistry practice, especially in the urgency endodontic practice. Studies have concluded that low intensity laser therapy is effective in treating pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulpitis, Acute Pain
- What is being tested?
- Laser 1 (at 0,16 Joules/point of irradiation) and Laser 2 (1,6 Joules/point of irradiation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Oct 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute pain due to irreversible inflammation of the a vital pulp tooth
Who cannot join
- Non-Intact Pulp chamber
- Necrotic pulp
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry - University of São Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: Effect of Low Power Laser in Pain Modulation During Irreversible Inflammation of Tooth Pulp
Anxiety, pain and discomfort are common stressful situations that occur during the dentistry practice, especially in the urgency endodontic practice. Studies have concluded that low intensity laser therapy is effective in treating pain. However, most studies have reported the low intensity laser therapy in chronic pain, few studies have shown its application on acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always completely effective. Thus, this present study aims to evaluate whether previous therapy with low intensity laser could, by its analgesic effect, promote greater comfort especially to this type of patient. 60 patients with acute pulpits pain will be selected to this study (randomized and double-blinded) and they will be divided in 4 groups:
Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) - Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02; Group 4 (n=15) - Placebo group - Sham Laser Irradiation.
The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham laser irradiation). After that, patients with acute pulp irreversible inflammation will be submitted to conventional endodontic urgency treatment. Data concerning the need of complimentary local anesthesia will be also taken into account. Data of different groups and times will be statistically compared.
- Conditions
- Pulpitis, Acute Pain
- Being tested
- No additional Intervention (control), Sham Laser Irradiation, Laser 1 (at 0,16 Joules/point of irradiation), Laser 2 (1,6 Joules/point of irradiation)
- Keywords
- Low power laser, Pulpitis, Pain
- Medical subject headings
- Pulpitis, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No additional Intervention (control)Other
No additional intervention previously to the urgency endodontic treatment (Control)
Sham Laser IrradiationRadiation
Fifteen minutes previously the urgency endodontic treatment, sham laser irradiation was performed in the tooth with irreversible inflammation in pulp.
Laser 1 (at 0,16 Joules/point of irradiation)Radiation
Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 0,16 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)
Laser 2 (1,6 Joules/point of irradiation)Radiation
Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 1,6 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Not described Receives: Other: No additional Intervention (control) |
| Sham Laser | Sham comparator | Not described Receives: Radiation: Sham Laser Irradiation |
| Laser 1 | Experimental | Low Power Laser applied at 0.16 Joules/point. 2 points of laser irradiation Receives: Radiation: Laser 1 (at 0,16 Joules/point of irradiation) |
| Laser 2 | Experimental | Low Power Laser applied at 16 Joules/point. 2 points of laser irradiation Receives: Radiation: Laser 2 (1,6 Joules/point of irradiation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation
Pain will be measured through VAS (Visual Analog Scale).
Measured: Immediately after low power laser irradiation and 15 minutes after low power laser irradiation
Secondary outcomes (1)
Need of anesthetic supplementation during urgency endodontic treatment
15 minutes after low power laser irradiation, patients will be submitted to endodontic urgency treatment adopted in School of Dentistry of University of São Paulo. The need of local anesthetic supplementation will be observed between the patients
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Karen Müller Ramalho, University of Sao Paulo
- Investigators
- Larissa MP Souza, DDS, Study chair, School of Dentistry - University of São PauloCarlos A Adde, PhD, Study chair, School of Dentistry - University of São PauloKaren M Ramalho, PhD, Principal investigator, School of Dentistry - University of São PauloIsabel P Tortamano, PhD, Principal investigator, School of Dentistry - University of São PauloCarlos P Eduardo, PhD, Study director, School of Dentistry - University of São PauloRodney G Rocha, PhD, Study director, School of Dentistry - University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169102
- Sponsor's protocol ID
- 08509912.3.0000.0075
- Status last verified
- Apr 2015
- First submitted
- 18 Jun 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Power Laser in Pain Modulation During Irreversible Inflammation of Tooth Pulp
- ClinicalTrials.gov ID
- NCT02169102
- Acronym / sponsor ID
- 08509912.3.0000.0075
- Conditions
- Pulpitis, Acute Pain
- Keywords
- Low power laser, Pulpitis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jun 2014 (estimated)
- 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.
Anxiety, pain and discomfort are common stressful situations that occur during the dentistry practice, especially in the urgency endodontic practice. Studies have concluded that low intensity laser therapy is effective in treating pain. However, most studies have reported the low intensity laser therapy in chronic pain, few studies have shown its application on acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always completely effective. Thus, this present study aims to evaluate whether previous therapy with low intensity laser could, by its analgesic effect, promote greater comfort especially to this type of patient. 60 patients with acute pulpits pain will be selected to this study (randomized and double-blinded) and they will be divided in 4 groups:
Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) - Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02; Group 4 (n=15) - Placebo group - Sham Laser Irradiation.
The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham laser irradiation). After that, patients with acute pulp irreversible inflammation will be submitted to conventional endodontic urgency treatment. Data concerning the need of complimentary local anesthesia will be also taken into account. Data of different groups and times will be statistically compared.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: No additional Intervention (control) |
| Sham Laser | Sham comparator | Radiation: Sham Laser Irradiation |
| Laser 1 | Experimental | Radiation: Laser 1 (at 0,16 Joules/point of irradiation)Low Power Laser applied at 0.16 Joules/point. 2 points of laser irradiation |
| Laser 2 | Experimental | Radiation: Laser 2 (1,6 Joules/point of irradiation)Low Power Laser applied at 16 Joules/point. 2 points of laser irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute pain due to irreversible inflammation of the a vital pulp tooth
Key exclusion criteria (2 listed)
- Non-Intact Pulp chamber
- Necrotic pulp
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 |
|---|---|---|
| No additional Intervention (control)No additional intervention previously to the urgency endodontic treatment (Control) | Other | Control |
| Sham Laser IrradiationFifteen minutes previously the urgency endodontic treatment, sham laser irradiation was performed in the tooth with irreversible inflammation in pulp. | Radiation | Sham Laser |
| Laser 1 (at 0,16 Joules/point of irradiation)Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 0,16 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region) | Radiation | Laser 1 |
| Laser 2 (1,6 Joules/point of irradiation)Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 1,6 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region) | Radiation | Laser 2 |
Primary outcome
Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation
Time frame: Immediately after low power laser irradiation and 15 minutes after low power laser irradiation
Pain will be measured through VAS (Visual Analog Scale).
1 secondary outcome
Need of anesthetic supplementation during urgency endodontic treatment
Time frame: 15 minutes
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 14 Apr 2015.
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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.
Larissa MP Souza, DDS study chair
School of Dentistry - University of São Paulo
Carlos A Adde, PhD study chair
School of Dentistry - University of São Paulo
Karen M Ramalho, PhD principal investigator
School of Dentistry - University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser 1 (at 0,16 Joules/point of irradiation) and Laser 2 (1,6 Joules/point of irradiation) in people with Pulpitis and Acute Pain, run by University of Sao Paulo at 1 site in Brazil.
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 1 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 14 Apr 2015. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation (time frame: Immediately after low power laser irradiation and 15 minutes after low power laser irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2015.