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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05344222
Other study ID # HALIURO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date March 29, 2022

Study information

Verified date April 2022
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date March 29, 2022
Est. primary completion date March 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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, - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Infrared LED
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 ED
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.

Locations

Country Name City State
Brazil University of Nove de Julho (UNINOVE) São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (45)

Alan H, Yolcu Ü, Koparal M, Özgür C, Öztürk SA, Malkoç S. Evaluation of the effects of the low-level laser therapy on swelling, pain, and trismus after removal of impacted lower third molar. Head Face Med. 2016 Jul 26;12(1):25. doi: 10.1186/s13005-016-012 — View Citation

Asutay F, Ozcan-Kucuk A, Alan H, Koparal M. Three-dimensional evaluation of the effect of low-level laser therapy on facial swelling after lower third molar surgery: A randomized, placebo-controlled study. Niger J Clin Pract. 2018 Sep;21(9):1107-1113. doi — View Citation

Braimah RO, Ndukwe KC, Owotade FJ, Aregbesola SB. Oral health related quality of life (OHRQoL) following third molar surgery in Sub-Saharan Africans: an observational study. Pan Afr Med J. 2016 Oct 19;25:97. doi: 10.11604/pamj.2016.25.97.7656. eCollection — View Citation

Cassetta M, Altieri F. The influence of mandibular third molar germectomy on the treatment time of impacted mandibular second molars using brass wire: a prospective clinical pilot study. Int J Oral Maxillofac Surg. 2017 Jul;46(7):905-911. doi: 10.1016/j.i — View Citation

Dawdy J, Halladay J, Carrasco-Labra A, Araya I, Yanine N, Brignardello-Petersen R. Efficacy of adjuvant laser therapy in reducing postsurgical complications after the removal of impacted mandibular third molars: A systematic review update and meta-analysi — View Citation

de Almeida P, Lopes-Martins RÁ, Tomazoni SS, Silva JA Jr, de Carvalho Pde T, Bjordal JM, Leal Junior EC. Low-level laser therapy improves skeletal muscle performance, decreases skeletal muscle damage and modulates mRNA expression of COX-1 and COX-2 in a d — View Citation

Demirsoy MS, Tumer MK, Erdil A, Ozkan Y. Evaluation of the effects of the surgical removal of impacted third molars on the emotional state of individuals with Beck depression inventory. Niger J Clin Pract. 2020 Oct;23(10):1407-1413. doi: 10.4103/njcp.njcp — View Citation

Domah F, Shah R, Nurmatov UB, Tagiyeva N. The Use of Low-Level Laser Therapy to Reduce Postoperative Morbidity After Third Molar Surgery: A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2021 Feb;79(2):313.e1-313.e19. doi: 10.1016/j.joms.202 — View Citation

Duarte-Rodrigues L, Miranda EFP, Souza TO, de Paiva HN, Falci SGM, Galvão EL. Third molar removal and its impact on quality of life: systematic review and meta-analysis. Qual Life Res. 2018 Oct;27(10):2477-2489. doi: 10.1007/s11136-018-1889-1. Epub 2018 M — View Citation

Eshghpour M, Ahrari F, Takallu M. Is Low-Level Laser Therapy Effective in the Management of Pain and Swelling After Mandibular Third Molar Surgery? J Oral Maxillofac Surg. 2016 Jul;74(7):1322.e1-8. doi: 10.1016/j.joms.2016.02.030. Epub 2016 Mar 12. — View Citation

Fernandes IA, Armond ACV, Falci SGM. The Effectiveness of the Cold Therapy (cryotherapy) in the Management of Inflammatory Parameters after Removal of Mandibular Third Molars: A Meta-Analysis. Int Arch Otorhinolaryngol. 2019 Apr;23(2):221-228. doi: 10.105 — View Citation

Fernandes 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):659-66 — View Citation

Ferraresi 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. Review. — View Citation

Gautam 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: — View Citation

Gil MLB, Marinho LMRF, de Moraes M, Wada RS, Groppo FC, Sato JE, de Sousa MLR. Effectiveness of Acupuncture in Dental Surgery: A Randomized, Crossover, Controlled Trial. J Acupunct Meridian Stud. 2020 Jun;13(3):104-109. doi: 10.1016/j.jams.2020.03.063. Ep — View Citation

González-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: 10.1080/14764172.2017.1 — View Citation

Gouvêa de Lima A, Villar RC, de Castro G Jr, Antequera R, Gil E, Rosalmeida MC, Federico MH, Snitcovsky IM. Oral mucositis prevention by low-level laser therapy in head-and-neck cancer patients undergoing concurrent chemoradiotherapy: a phase III randomiz — View Citation

Guedes 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 F — View Citation

Hamid MA. Low-level Laser Therapy on Postoperative Pain after Mandibular Third Molar Surgery. Ann Maxillofac Surg. 2017 Jul-Dec;7(2):207-216. doi: 10.4103/ams.ams_5_17. — View Citation

Ibikunle AA, Adeyemo WL. Oral health-related quality of life following third molar surgery with or without application of ice pack therapy. Oral Maxillofac Surg. 2016 Sep;20(3):239-47. doi: 10.1007/s10006-016-0558-1. Epub 2016 May 3. — View Citation

Isolan C, Kinalski MD, Leão OA, Post LK, Isolan TM, Dos Santos MB. Photobiomodulation therapy reduces postoperative pain after third molar extractions: A randomized clinical trial. Med Oral Patol Oral Cir Bucal. 2021 May 1;26(3):e341-e348. doi: 10.4317/me — View Citation

Khorshidi Khiavi R, Pourallahverdi M, Pourallahverdi A, Ghorani Khiavi S, Ghertasi Oskouei S, Mokhtari H. Pain control following impacted third molar surgery with bupivacaine irrigation of tooth socket: a prospective study. J Dent Res Dent Clin Dent Prosp — View Citation

Koçer 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.2013.11.0 — View Citation

Koparal M, Kucuk AO, Alan H, Asutay F, Avci M. Effects of low-level laser therapy following surgical extraction of the lower third molar with objective measurement of swelling using a three-dimensional system. Exp Ther Med. 2018 Apr;15(4):3820-3826. doi: — View Citation

Leal 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) appli — View Citation

Leal 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 — View Citation

Leal 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 h — View Citation

López-Ramírez M, Vílchez-Pérez MA, Gargallo-Albiol J, Arnabat-Domínguez 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. L — View Citation

Marín-Conde F, Castellanos-Cosano L, Pachón-Ibañez J, Serrera-Figallo MA, Gutiérrez-Pérez JL, Torres-Lagares D. Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized contr — View Citation

Momeni E, Barati H, Arbabi MR, Jalali B, Moosavi MS. Low-level laser therapy using laser diode 940 nm in the mandibular impacted third molar surgery: double-blind randomized clinical trial. BMC Oral Health. 2021 Feb 18;21(1):77. doi: 10.1186/s12903-021-01 — View Citation

Noba C, Mello-Moura ACV, Gimenez T, Tedesco TK, Moura-Netto C. Laser for bone healing after oral surgery: systematic review. Lasers Med Sci. 2018 Apr;33(3):667-674. doi: 10.1007/s10103-017-2400-x. Epub 2017 Dec 1. Review. — View Citation

Oguz O. The proportion of the face in younger adults using the thumb rule of Leonardo da Vinci. Surg Radiol Anat. 1996;18(2):111-4. — View Citation

Petrini M, Ferrante M, Trentini P, Perfetti G, Spoto G. Effect of pre-operatory low-level laser therapy on pain, swelling, and trismus associated with third-molar surgery. Med Oral Patol Oral Cir Bucal. 2017 Jul 1;22(4):e467-e472. — View Citation

Raiesian S, Khani M, Khiabani K, Hemmati E, Pouretezad M. Assessment of Low-Level Laser Therapy Effects After Extraction of Impacted Lower Third Molar Surgery. J Lasers Med Sci. 2017 Winter;8(1):42-45. doi: 10.15171/jlms.2017.08. Epub 2017 Jan 8. — View Citation

Rezk-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. — View Citation

Rodrigues ÉD, Pereira GS, Vasconcelos BC, Ribeiro RC. Effect of preemptive dexamethasone and etoricoxib on postoperative period following impacted third molar surgery - a randomized clinical trial. Med Oral Patol Oral Cir Bucal. 2019 Nov 1;24(6):e746-e751 — View Citation

Sales PHDH, Barros AWP, Silva PGB, Vescovi P, Leão JC. Is the Er: YAG Laser Effective in Reducing Pain, Edema, and Trismus After Removal of Impacted Mandibular Third Molars? A Meta-Analysis. J Oral Maxillofac Surg. 2022 Mar;80(3):501-516. doi: 10.1016/j.j — View Citation

Selimovic E, Ibrahimagic-Šeper L, Šišic 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: 10.17392/871-1 — View Citation

Shugars DA, Benson K, White RP Jr, Simpson KN, Bader JD. Developing a measure of patient perceptions of short-term outcomes of third molar surgery. J Oral Maxillofac Surg. 1996 Dec;54(12):1402-8. — View Citation

Silva LC, Sacono NT, Freire Mdo C, Costa LR, Batista AC, Silva GB. The Impact of Low-Level Laser Therapy on Oral Mucositis and Quality of Life in Patients Undergoing Hematopoietic Stem Cell Transplantation Using the Oral Health Impact Profile and the Func — View Citation

Singh T, More V, Fatima U, Karpe T, Aleem MA, Prameela J. Effect of proteolytic enzyme bromelain on pain and swelling after removal of third molars. J Int Soc Prev Community Dent. 2016 Dec;6(Suppl 3):S197-S204. doi: 10.4103/2231-0762.197192. — View Citation

Sortino F, Cicciù M. Strategies used to inhibit postoperative swelling following removal of impacted lower third molar. Dent Res J (Isfahan). 2011 Oct;8(4):162-71. doi: 10.4103/1735-3327.86031. — View Citation

Toma RL, Tucci HT, Antunes HK, Pedroni CR, de Oliveira AS, Buck I, Ferreira PD, Vassão 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: 10.100 — View Citation

Uslu MÖ, Akgül S. Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life. Lasers Med Sci. 2020 Sep;35(7):1637-1647. doi: 1 — View Citation

Vanin 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, pla — View Citation

* Note: There are 45 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Throught study completion, an average 48
Primary 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).
Throught study completion, an average 48
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