NCT05344222

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

March 31, 2022

Last Update Submit

April 19, 2022

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

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.

Device: Similar device - Infrared ED

Interventions

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.

Photobiomodulation
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.

Sham Photobiomodulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

Location

Related Publications (45)

  • 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.

    PMID: 27612525RESULT

  • Lopez-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.

    PMID: 21617973RESULT

  • Kocer 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.

    PMID: 24332587RESULT

  • 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):659-668. doi: 10.1016/j.ijom.2018.09.014. Epub 2018 Oct 14.

    PMID: 30327153RESULT

  • 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 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.

    PMID: 20436237RESULT

  • Toma 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.

    PMID: 23296713RESULT

  • 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, placebo-controlled trial. Lasers Med Sci. 2017 Jan;32(1):253. doi: 10.1007/s10103-016-2121-6. No abstract available.

    PMID: 27924418RESULT

  • 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.

    PMID: 27874264RESULT

  • 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 humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.

    PMID: 19731300RESULT

  • 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) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.

    PMID: 19302015RESULT

  • 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: 10.1016/j.jphotobiol.2015.01.011. Epub 2015 Feb 7.

    PMID: 25704314RESULT

  • 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 Feb 22;2018:4579279. doi: 10.1155/2018/4579279. eCollection 2018.

    PMID: 29681940RESULT

  • Marin-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.

    PMID: 30591391RESULT

  • 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.

    PMID: 31360381RESULT

  • Gonzalez-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.

    PMID: 29020483RESULT

  • 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 Functional Assessment of Cancer Therapy-Bone Marrow Transplantation Questionnaires. Photomed Laser Surg. 2015 Jul;33(7):357-63. doi: 10.1089/pho.2015.3911.

    PMID: 26154723RESULT

  • Gouvea 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 randomized study. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):270-5. doi: 10.1016/j.ijrobp.2010.10.012. Epub 2010 Dec 14.

    PMID: 21163585RESULT

  • Sales PHDH, Barros AWP, Silva PGB, Vescovi P, Leao 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.joms.2021.10.006. Epub 2021 Oct 20.

    PMID: 34793714RESULT

  • 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. doi: 10.1007/BF01795228.

    PMID: 8782316RESULT

  • Rodrigues ED, 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. doi: 10.4317/medoral.23095.

    PMID: 31655834RESULT

  • 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. doi: 10.1016/s0278-2391(96)90253-0.

    PMID: 8957118RESULT

  • 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 2016.

    PMID: 28292060RESULT

  • 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.

    PMID: 27139019RESULT

  • 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.ijom.2017.03.027. Epub 2017 Apr 10.

    PMID: 28408148RESULT

  • Duarte-Rodrigues L, Miranda EFP, Souza TO, de Paiva HN, Falci SGM, Galvao 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 May 24.

    PMID: 29797177RESULT

  • 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/s12903-021-01434-1.

    PMID: 33602198RESULT

  • 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: 10.4103/njcp.njcp_38_18.

    PMID: 30156193RESULT

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    PMID: 27457369RESULT

  • 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: 10.3892/etm.2018.5921. Epub 2018 Mar 2.

    PMID: 29581740RESULT

  • 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.

    PMID: 28217537RESULT

  • 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_603_19.

    PMID: 33047698RESULT

  • Isolan C, Kinalski MD, Leao 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/medoral.24228.

    PMID: 33340081RESULT

  • Uslu MO, Akgul 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: 10.1007/s10103-020-03037-8. Epub 2020 May 20.

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  • 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.

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  • 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: 10.1055/s-0039-1677755. Epub 2019 Mar 13.

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  • de Almeida P, Lopes-Martins RA, 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 dose-dependent manner. Photochem Photobiol. 2011 Sep-Oct;87(5):1159-63. doi: 10.1111/j.1751-1097.2011.00968.x. Epub 2011 Aug 17.

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Related Links

Study Officials

  • ERIKA MELLO

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
An external investigator was assigned to perform randomization. Containing the type of treatment to be used inside, unidentified envelopes were drawn among the participants, resulting in two groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 25, 2022

Study Start

July 1, 2021

Primary Completion

March 29, 2022

Study Completion

March 29, 2022

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

BR(1)