Impacted Third Molar ToothNCT05344222
Effects of Photobiomodulation Conditioning in Impacted Third Molars
A study testing Infrared LED and Similar device - Infrared ED in people with Impacted Third Molar Tooth, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The removal of third molars should be considered to avoid problems such as cysts and other complications. Surgical intervention with the manipulation of oral tissues has the undesirable postoperative effects of pain, trismus (limited mouth opening) and edema. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Infrared LED and Similar device - Infrared ED
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2021to 29 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female adults (18 years of age or older)
- no tumors in the oral region,
- not having undergone psychiatric treatment in the previous year,
- good general health,
- satisfactory oral hygiene,
- impacted mandibular third molar
- signed statement of informed consent.
Who cannot join
- habitual use of analgesic or anti-inflammatory medication for other comorbidities,
- undergoing neurological/psychiatric treatment,
- teeth with lesions to be treated in the same hemi-arch as the tooth to be removed,
- systemic disease,
- current smoking habit,
- pericoronitis in the previous 30 days,
Show all 17Show fewer
- pregnant or nursing women,
- poor oral hygiene,
- photosensitivity disorder,
- tumor in the oral region,
- heart disease,
- diabetes,
- blood dyscrasia,
- chemical dependency,
- allergy to medications used in the study,
- ankylosis of the temporomandibular joint
- intraoperative complications with surgery time exceeding 90 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Photobiomodulation Conditioning of Orofacial Tissue in Surgery for Removal of Impacted Mandibular Third Molars: Randomized, Sham-controlled, Double-blind Clinical Trial
The removal of third molars should be considered to avoid problems such as cysts and other complications. Surgical intervention with the manipulation of oral tissues has the undesirable postoperative effects of pain, trismus (limited mouth opening) and edema. Photobiomodulation has also proved effective regarding reductions in pain, edema and trismus. The aim of the present study was to evaluate the effectiveness of photobiomodulation for the conditioning of tissues involved in the surgical removal of impacted mandibular third molars in terms of reducing or eliminating postoperative pain, trismus and edema.
Read the detailed description
The investigator will select 62 patients from Nove de Julho Clinics, minimal 18 years old, with impacted third molar teeth. The volunteers will be randomly allocated to two groups using a block randomization process: photobiomodulation group (PG) and sham group (SG). The same surgeon and assistant performed all operations. The surgeon, assistant and patients will be all blinded to the LED treatment protocol. The participants in the active photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm 08J 80 seconds perpendicular to the surface of the skin in gentle stationary contact at three extraoral points. For the participants in the sham group, a device with a similar appearance will be used that did not emit radiation. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. The visual analog scale will be used for the measurement of pain intensity, facial measurements evaluated edema. Mouth opening range will be measured with sterilized manual calipers between the incisal edge of the maxillary and mandibular central incisors. The distribution of the data (normal or non-normal) will be determined using the Shapiro-Wilks test. Data with normal distribution will be analyzed using two-way repeated-measures analysis of variance (ANOVA), the t-test for two groups with independent measures and the paired t-test for two groups with dependent measures. Data with non-normal distribution will be analyzed using the Wilcoxon test for paired data and the Mann-Whitney test for independent data. Categorical data will be analyzed using Fisher's exact test for independent data and McNemar's test for paired data. The significance level will be set at α = 0.05.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Infrared LED, Similar device - Infrared ED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared LEDDevice
The participants in the active photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm perpendicular to the surface of the skin in gentle stationary contact at three extraoral points. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation.
Similar device - Infrared EDDevice
For the participants in the sham group, a device with a similar appearance will be used that did not emit radiation. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | The participants in the active photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm perpendicular to the surface of the skin in gentle stationary contact at three extraoral points. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. Receives: Device: Infrared LED |
| Sham Photobiomodulation | Sham comparator | For the participants in the sham group, a device with a similar appearance will be used that did not emit radiation. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. Receives: Device: Similar device - Infrared ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infrared Led.
In the immediate pre-surgery period, three measurements were taken on the face of the patient with a previously sterilized flexible metric tape (centimeters): tragus - pogonion; tragus - lip commissure; and angle of mandible - outer orbicular commissure. Mouth opening range was measured (centimeters) with sterilized manual calipers between the incisal edge of the maxillary and mandibular central incisors The visual analog scale was used for the measurement of pain intensity. Each patient marked a point along a line between two extremes numbered zero (no pain) to 10 (worst possible pain) to represent the pain felt at moment of evaluation (69,70).
Measured: Throught study completion, an average 48
Infrared LED - similar device
In the immediate pre-surgery period, three measurements were taken on the face of the patient with a previously sterilized flexible metric tape (centimeters): tragus - pogonion; tragus - lip commissure; and angle of mandible - outer orbicular commissure. Mouth opening range was measured (centimeters) with sterilized manual calipers between the incisal edge of the maxillary and mandibular central incisors.
The visual analog scale was used for the measurement of pain intensity. Each patient marked a point along a line between two extremes numbered zero (absence of pain) to 10 (worst pain imaginable) to represent the pain felt at moment of evaluation (69,70).
Measured: Throught study completion, an average 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jul 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- ERIKA MELLO, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344222
- Sponsor's protocol ID
- HALIURO
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Selimovic E, Ibrahimagic-Seper L, Sisic I, Sivic S, Huseinagic S. Prevention of trismus with different pharmacological therapies after surgical extraction of impacted mandibular third molar. Med Glas (Zenica). 2017 Feb 1;14(1):145-151. doi: 10.17392/871-16.
PubMed 27612525Lopez-Ramirez M, Vilchez-Perez MA, Gargallo-Albiol J, Arnabat-Dominguez J, Gay-Escoda C. Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after a lower third molar extraction. A preliminary study. Lasers Med Sci. 2012 May;27(3):559-66. doi: 10.1007/s10103-011-0936-8. Epub 2011 May 27.
PubMed 21617973Kocer G, Yuce E, Tuzuner Oncul A, Dereci O, Koskan O. Effect of the route of administration of methylprednisolone on oedema and trismus in impacted lower third molar surgery. Int J Oral Maxillofac Surg. 2014 May;43(5):639-43. doi: 10.1016/j.ijom.2013.11.005. Epub 2013 Dec 12.
PubMed 24332587Fernandes IA, de Souza GM, Pinheiro MLP, Falci SGM. Intramuscular injection of dexamethasone for the control of pain, swelling, and trismus after third molar surgery: a systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2019 May;48(5):659-668. doi: 10.1016/j.ijom.2018.09.014. Epub 2018 Oct 14.
PubMed 30327153Leal Junior EC, Lopes-Martins RA, Frigo L, De Marchi T, Rossi RP, de Godoi V, Tomazoni SS, Silva DP, Basso M, Filho PL, de Valls Corsetti F, Iversen VV, Bjordal JM. Effects of low-level laser therapy (LLLT) in the development of exercise-induced skeletal muscle fatigue and changes in biochemical markers related to postexercise recovery. J Orthop Sports Phys Ther. 2010 Aug;40(8):524-32. doi: 10.2519/jospt.2010.3294.
PubMed 20436237Toma RL, Tucci HT, Antunes HK, Pedroni CR, de Oliveira AS, Buck I, Ferreira PD, Vassao PG, Renno AC. Effect of 808 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in elderly women. Lasers Med Sci. 2013 Sep;28(5):1375-82. doi: 10.1007/s10103-012-1246-5. Epub 2013 Jan 8.
PubMed 23296713Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Carvalho PT, Leal-Junior EC. Erratum to: What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial. Lasers Med Sci. 2017 Jan;32(1):253. doi: 10.1007/s10103-016-2121-6. No abstract available.
PubMed 27924418Ferraresi C, Huang YY, Hamblin MR. Photobiomodulation in human muscle tissue: an advantage in sports performance? J Biophotonics. 2016 Dec;9(11-12):1273-1299. doi: 10.1002/jbio.201600176. Epub 2016 Nov 22.
PubMed 27874264Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.
PubMed 19731300Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.
PubMed 19302015Gautam AP, Fernandes DJ, Vidyasagar MS, Maiya AG, Guddattu V. Low level laser therapy against radiation induced oral mucositis in elderly head and neck cancer patients-a randomized placebo controlled trial. J Photochem Photobiol B. 2015 Mar;144:51-6. doi: 10.1016/j.jphotobiol.2015.01.011. Epub 2015 Feb 7.
PubMed 25704314Guedes CDCFV, de Freitas Filho SAJ, de Faria PR, Loyola AM, Sabino-Silva R, Cardoso SV. Variation of Energy in Photobiomodulation for the Control of Radiotherapy-Induced Oral Mucositis: A Clinical Study in Head and Neck Cancer Patients. Int J Dent. 2018 Feb 22;2018:4579279. doi: 10.1155/2018/4579279. eCollection 2018.
PubMed 29681940Marin-Conde F, Castellanos-Cosano L, Pachon-Ibanez J, Serrera-Figallo MA, Gutierrez-Perez JL, Torres-Lagares D. Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized controlled trial. Int J Oral Maxillofac Surg. 2019 Jul;48(7):917-923. doi: 10.1016/j.ijom.2018.12.006. Epub 2018 Dec 24.
PubMed 30591391Rezk-Allah SS, Abd Elshaf HM, Farid RJ, Hassan MAE, Alsirafy SA. Effect of Low-Level Laser Therapy in Treatment of Chemotherapy Induced Oral Mucositis. J Lasers Med Sci. 2019 Spring;10(2):125-130. doi: 10.15171/jlms.2019.20. Epub 2019 Feb 25.
PubMed 31360381Gonzalez-Arriagada WA, Ramos LMA, Andrade MAC, Lopes MA. Efficacy of low-level laser therapy as an auxiliary tool for management of acute side effects of head and neck radiotherapy. J Cosmet Laser Ther. 2018 Apr;20(2):117-122. doi: 10.1080/14764172.2017.1376097. Epub 2017 Dec 4.
PubMed 29020483
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Conditioning of Orofacial Tissue in Surgery for Removal of Impacted Mandibular Third Molars: Randomized, Sham-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05344222
- Acronym / sponsor ID
- HALIURO
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 25 Apr 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.
The removal of third molars should be considered to avoid problems such as cysts and other complications. Surgical intervention with the manipulation of oral tissues has the undesirable postoperative effects of pain, trismus (limited mouth opening) and edema. Photobiomodulation has also proved effective regarding reductions in pain, edema and trismus. The aim of the present study was to evaluate the effectiveness of photobiomodulation for the conditioning of tissues involved in the surgical removal of impacted mandibular third molars in terms of reducing or eliminating postoperative pain, trismus and edema.
Detailed description
The investigator will select 62 patients from Nove de Julho Clinics, minimal 18 years old, with impacted third molar teeth. The volunteers will be randomly allocated to two groups using a block randomization process: photobiomodulation group (PG) and sham group (SG). The same surgeon and assistant performed all operations. The surgeon, assistant and patients will be all blinded to the LED treatment protocol. The participants in the active photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm 08J 80 seconds perpendicular to the surface of the skin in gentle stationary contact at three extraoral points. For the participants in the sham group, a device with a similar appearance will be used that did not emit radiation. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. The visual analog scale will be used for the measurement of pain intensity, facial measurements evaluated edema. Mouth opening range will be measured with sterilized manual calipers between the incisal edge of the maxillary and mandibular central incisors. The distribution of the data (normal or non-normal) will be determined using the Shapiro-Wilks test. Data with normal distribution will be analyzed using two-way repeated-measures analysis of variance (ANOVA), the t-test for two groups with independent measures and the paired t-test for two groups with dependent measures. Data with non-normal distribution will be analyzed using the Wilcoxon test for paired data and the Mann-Whitney test for independent data. Categorical data will be analyzed using Fisher's exact test for independent data and McNemar's test for paired data. The significance level will be set at α = 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Infrared LEDThe participants in the active photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm perpendicular to the surface of the skin in gentle stationary contact at three extraoral points. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. |
| Sham Photobiomodulation | Sham comparator | Device: Similar device - Infrared EDFor the participants in the sham group, a device with a similar appearance will be used that did not emit radiation. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- male and female adults (18 years of age or older)
- no tumors in the oral region,
- not having undergone psychiatric treatment in the previous year,
- good general health,
- satisfactory oral hygiene,
Key exclusion criteria (17 listed)
- habitual use of analgesic or anti-inflammatory medication for other comorbidities,
- undergoing neurological/psychiatric treatment,
- teeth with lesions to be treated in the same hemi-arch as the tooth to be removed,
- systemic disease,
- current smoking habit,
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 |
|---|---|---|
| Infrared LEDThe participants in the active photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm perpendicular to the surface of the skin in gentle stationary contact at three extraoral points. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. | Device | Photobiomodulation |
| Similar device - Infrared EDFor the participants in the sham group, a device with a similar appearance will be used that did not emit radiation. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation. | Device | Sham Photobiomodulation |
Primary outcome
Infrared Led.
Time frame: Throught study completion, an average 48
In the immediate pre-surgery period, three measurements were taken on the face of the patient with a previously sterilized flexible metric tape (centimeters): tragus - pogonion; tragus - lip commissure; and angle of mandible - outer orbicular commissure. Mouth opening range was measured (centimeters) with sterilized manual calipers between the incisal edge of the maxillary and mandibular central incisors The visual analog scale was used for the measurement of pain intensity. Each patient marked a point along a line between two extremes numbered zero (no pain) to 10 (worst possible pain) to represent the pain felt at moment of evaluation (69,70).
Infrared LED - similar device
Time frame: Throught study completion, an average 48
In the immediate pre-surgery period, three measurements were taken on the face of the patient with a previously sterilized flexible metric tape (centimeters): tragus - pogonion; tragus - lip commissure; and angle of mandible - outer orbicular commissure. Mouth opening range was measured (centimeters) with sterilized manual calipers between the incisal edge of the maxillary and mandibular central incisors. The visual analog scale was used for the measurement of pain intensity. Each patient marked a point along a line between two extremes numbered zero (absence of pain) to 10 (worst pain imaginable) to represent the pain felt at moment of evaluation (69,70).
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 25 Apr 2022.
- Results publication: PubMed 27612525Selimovic E, Ibrahimagic-Seper L, Sisic I, Sivic S, Huseinagic S. Prevention of trismus with different pharmacological therapies after surgical extraction of impacted mandibular third molar. Med Glas (Zenica). 2017 Feb 1;14(1):145-151. doi: 10.17392/871-16.
- Results publication: PubMed 21617973Lopez-Ramirez M, Vilchez-Perez MA, Gargallo-Albiol J, Arnabat-Dominguez J, Gay-Escoda C. Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after a lower third molar extraction. A preliminary study. Lasers Med Sci. 2012 May;27(3):559-66. doi: 10.1007/s10103-011-0936-8. Epub 2011 May 27.
- Results publication: PubMed 24332587Kocer G, Yuce E, Tuzuner Oncul A, Dereci O, Koskan O. Effect of the route of administration of methylprednisolone on oedema and trismus in impacted lower third molar surgery. Int J Oral Maxillofac Surg. 2014 May;43(5):639-43. doi: 10.1016/j.ijom.2013.11.005. Epub 2013 Dec 12.
- Results publication: PubMed 30327153Fernandes IA, de Souza GM, Pinheiro MLP, Falci SGM. Intramuscular injection of dexamethasone for the control of pain, swelling, and trismus after third molar surgery: a systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2019 May;48(5):659-668. doi: 10.1016/j.ijom.2018.09.014. Epub 2018 Oct 14.
- Results publication: PubMed 20436237Leal Junior EC, Lopes-Martins RA, Frigo L, De Marchi T, Rossi RP, de Godoi V, Tomazoni SS, Silva DP, Basso M, Filho PL, de Valls Corsetti F, Iversen VV, Bjordal JM. Effects of low-level laser therapy (LLLT) in the development of exercise-induced skeletal muscle fatigue and changes in biochemical markers related to postexercise recovery. J Orthop Sports Phys Ther. 2010 Aug;40(8):524-32. doi: 10.2519/jospt.2010.3294.
- Results publication: PubMed 23296713Toma RL, Tucci HT, Antunes HK, Pedroni CR, de Oliveira AS, Buck I, Ferreira PD, Vassao PG, Renno AC. Effect of 808 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in elderly women. Lasers Med Sci. 2013 Sep;28(5):1375-82. doi: 10.1007/s10103-012-1246-5. Epub 2013 Jan 8.
- Results publication: PubMed 27924418Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Carvalho PT, Leal-Junior EC. Erratum to: What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial. Lasers Med Sci. 2017 Jan;32(1):253. doi: 10.1007/s10103-016-2121-6. No abstract available.
- Results publication: PubMed 27874264Ferraresi C, Huang YY, Hamblin MR. Photobiomodulation in human muscle tissue: an advantage in sports performance? J Biophotonics. 2016 Dec;9(11-12):1273-1299. doi: 10.1002/jbio.201600176. Epub 2016 Nov 22.
- Results publication: PubMed 19731300Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.
- Results publication: PubMed 19302015Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.
- Results publication: PubMed 25704314Gautam AP, Fernandes DJ, Vidyasagar MS, Maiya AG, Guddattu V. Low level laser therapy against radiation induced oral mucositis in elderly head and neck cancer patients-a randomized placebo controlled trial. J Photochem Photobiol B. 2015 Mar;144:51-6. doi: 10.1016/j.jphotobiol.2015.01.011. Epub 2015 Feb 7.
- Results publication: PubMed 29681940Guedes CDCFV, de Freitas Filho SAJ, de Faria PR, Loyola AM, Sabino-Silva R, Cardoso SV. Variation of Energy in Photobiomodulation for the Control of Radiotherapy-Induced Oral Mucositis: A Clinical Study in Head and Neck Cancer Patients. Int J Dent. 2018 Feb 22;2018:4579279. doi: 10.1155/2018/4579279. eCollection 2018.
- Roochi MM, Heidar H, Kordi S, Bahrami N. Efficacy of low level laser for prevention of pain and trismus after impacted mandibular third molar surgery. J Craniomaxillofacial Res. Published online May 16, 2017:284-288. Accessed January 21, 2021Link provided by the sponsor.
- Martins M, Garcia MAPY, Fernandes MV, et al. Principais complicações clínicas odontológicas pós-operatórias da cirurgia de terceiro molar incluso/impactado. ConScientiae Saúde. 2010;9(2):278-284Link provided by the sponsor.
- Hummig W, Grossmann E. Use of viminol in acute pain management after third molars extraction. Case report. BrJP. 2018;1(2):188-191.Link provided by the sponsor.
- Vicente Â, Loffi AOB, Nesi H. Uso de corticosteroide no pré-operatório em cirurgia de terceiros molares. Rev Bras Odontol. 2013;70(1):22-27.Link provided by the sponsor.
- Medeiros ACR, Branco GLC, Moura LA de. LASER THERAPY IN MOLARS SURGERY IMPACTED: SYSTEMATIC REVIEW. Focus Oral Res. 2019;2(1):59-66. doi:10.35169/for.v2i1.44Link provided by the sponsor.
- Gonçalves RD. Abordagem fisioterapêutica no tratamento dos edemas pós cirurgias plásticas. Published online June 12, 2015. Accessed October 25, 2020Link provided by the sponsor.
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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.
ERIKA MELLO principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared LED and Similar device - Infrared ED in people with Impacted Third Molar Tooth, run by University of Nove de Julho 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 7 inclusion and 17 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 25 Apr 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 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?
Infrared Led. (time frame: Throught study completion, an average 48). 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 NCT05344222, which also lists 45 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 25 Apr 2022.