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A comparative randomized clinical trial to assess the effectiveness of the diode lasers in both contact and non-contact mode and 0.1% triamcinolone acetonide mouth paste in treatment of oral ulcers—an in vivo study

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Abstract

Introduction

Ulceration is the breach in the oral epithelium, which typically exposes nerve endings in the underlying lamina propria, resulting in pain and soreness. Oral ulcers are very common, with an estimated point prevalence of 4% worldwide. Current treatment options available include topical agents, systemic and topical corticosteroids, cauterization, antibiotics, multivitamins, adhesive pastes, local antiseptics, analgesics, anti-inflammatory, mouth rinses containing active enzymes, and photobiomodulation therapy (PBMT). Laser constitutes an alternative to processes that alleviate pain and inflammatory reaction and is now widely used in management of diseases that require tissue regeneration. Keeping in mind the analgesic, anti-inflammatory, and bio-stimulatory properties of PBMT, we conducted a study to analyze the effectiveness of PBMT in both contact and non-contact mode in relation to pain in ulcer, size, and healing time.

Method

A total of 45 patients with ulcers were included and randomly divided them into 3 equal groups undergoing laser therapy (contact mode, non-contact mode) and conventional treatment, i.e., 0.1%triamcinolone acetonide. All the patients were examined on day 0, 2, 4, and 6 to check for pain, size of ulcer, and healing time. Also, frequency of recurrence was also assessed in a 1-year follow-up.

Results

ANOVA followed by post hoc comparison by Bonferroni method was done which revealed that PBMT in non-contact mode provided immediate pain relief and significantly reduced healing time with less recurrence followed by PBMT in contact mode.

Conclusion

PBMT in non-contact mode was more effective in relieving pain and reducing the healing time during the treatment of oral ulcers compared with triamcinolone acetonide and laser in contact mode. Also, less recurrence was seen even after 1-year of follow-up. Hence, it can be concluded that PBMT in non-contact and contact mode is a safe and clinically effective therapy for treating oral ulcers.

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Authors and Affiliations

Authors

Corresponding author

Correspondence to Manmeet Kour.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the Ethical Committee of the ITS Centre for Dental Studies & Research.

Informed consent

Informed consent was obtained from the patients prior to participation in the study.

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Appendices

Annexure 1

ETHICAL COMMITTEE CLEARANCE CERTIFICATE

The Ethical Committee of The I.T.S Centre for Dental Studies & Research met on 10th & 11th November, 2016 to examine & approve Thesis protocols for the dissertation to be submitted by MDS students admitted during academic year 2016–17 (session 2016–19) & Research protocols to be submitted by faculty for ethical clearance.

Members present:

1. Dr. Prem Chopra

Chairperson & Basic Medical Scientist

2. Dr. Anmol Kalha

Clinician

3. Dr. Puneet Ahuja

Clinician

4. Dr. Devi Charan Shetty

Clinican

5. Dr. C.S. Ram

Physiotherapy- clinician

6. Dr. F.K. Pandey

Biotechnologist

7. Dr. Rishi Rath

Pharmacologist

8. Dr. Anil Chandna

Clinician

9. Dr. A.C. Verma

Social Scientist

10. Dr. Dinesh Samujh

Legal Expert

11. Mr. Jaipal Singh

Layperson

12. Dr. Vinod Sachdev

Member Secretary

Decision of the Committee

The committee has cleared the thesis protocol titled A comparative randomized clinical trial to assess the effectiveness of the diode lasers in both contact & non-contact mode and 0.1% triamcinolone acetonide mouth paste in treatment of oral ulcers – an Invivo study”. - submitted by Dr. Manmeet Kour Post Graduate Student in the Department of Oral Medicine and Radiology.

(Dr. Vinod Sachdev)

Member Secretary & Director-PG Studies

Annexure 2

CONSENT FORM

This informed consent form is for men and women who attend OPD of ITS- CDSR Muradnagar, Ghaziabad and who are invited to participate in the research.

Name of principal investigator: Dr. MANMEET KOUR

Name of the organization: ITS-CDSR, Muradnagar, Ghaziabad.

TOPIC

A comparative randomized clinical trial to assess the effectiveness of the diode lasers in both contact & non-contact mode and 0.1% triamcinolone acetonide mouth paste in treatment of oral ulcers – an Invivo study

Information sheet

The information is this document is meant to help to decide whether or not take part in the study please feel free to ask if you have any queries or corner.

  • A detail history and thorough clinical examination will be done under study followed by recording of findings in a predetermined case history profoma.

  • Your personal detail will be kept confidential and will not be used in the study.

  • All your investigations will be done free of charge.

  • No reported side effect from this therapy, if any, report to the investigator.

The results of study will benefits to society in terms of advancements of medical knowledge and or therapeutic benefits to future patients.

Certificate of consent

I understand that my participation in the study is voluntary and that I have the right to withdraw at any time without giving any reason, without my medical or legal rights being affected.

I agree to take part in the above study. I confirm that I have received a copy of the subject information sheet along with this signed and dated informed consent form.

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Kour, M., Dwivedi, A. A comparative randomized clinical trial to assess the effectiveness of the diode lasers in both contact and non-contact mode and 0.1% triamcinolone acetonide mouth paste in treatment of oral ulcers—an in vivo study. Laser Dent Sci 4, 33–42 (2020). https://doi.org/10.1007/s41547-020-00086-8

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  • DOI: https://doi.org/10.1007/s41547-020-00086-8

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