drugset / Trial / NCT05147376
Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances
RandomizedParallel-groupDouble-blindPrevention
Summary
The study is a randomized controlled trial. The participants will be equally allocated into 2 groups to compare clinical effectiveness of curcumin mouthwash in fixed orthodontic patients during the first month of treatment.
Timeline
- Start
- 2022-02-21
- Primary completion
- 2023-08-07
- Completion
- 2023-08-07
Publications
- Background Akbik D, Ghadiri M, Chrzanowski W, Rohanizadeh R. Curcumin as a wound healing agent. Life Sci. 2014 Oct 22;116(1):1-7. doi: 10.1016/j.lfs.2014.08.016. Epub 2014 Sep 6.
- Background Baricevic M, Mravak-Stipetic M, Majstorovic M, Baranovic M, Baricevic D, Loncar B. Oral mucosal lesions during orthodontic treatment. Int J Paediatr Dent. 2011 Mar;21(2):96-102. doi: 10.1111/j.1365-263X.2010.01078.x. Epub 2010 Dec 2.
- Background Chattopadhyay I, Biswas K, Bandyopadhyay U, Banerjee RK. Turmeric and curcumin: Biological actions and medicinal applications. CURRENT SCIENCE-BANGALORE-. 2004;87:44-53.
- Background Duggi S, Handral H, Handral R, G T, Sd DS. Turmeric: Nature's precious medicine. Asian Journal of Pharmaceutical and Clinical Research. 2013;6:10-6.
- Background Emiroglu G, Ozergin Coskun Z, Kalkan Y, Celebi Erdivanli O, Tumkaya L, Terzi S, Ozgur A, Demirci M, Dursun E. The Effects of Curcumin on Wound Healing in a Rat Model of Nasal Mucosal Trauma. Evid Based Complement Alternat Med. 2017;2017:9452392. doi: 10.1155/2017/9452392. Epub 2017 Sep 5.
- Background Fitzpatrick SG, Cohen DM, Clark AN. Ulcerated Lesions of the Oral Mucosa: Clinical and Histologic Review. Head Neck Pathol. 2019 Mar;13(1):91-102. doi: 10.1007/s12105-018-0981-8. Epub 2019 Mar 7.
- Background Jurenka JS. Anti-inflammatory properties of curcumin, a major constituent of Curcuma longa: a review of preclinical and clinical research. Altern Med Rev. 2009 Jun;14(2):141-53.
- Background Khan RMS, Hassan KR, Rizwan M, Ashraf J. Prevalence and type of oral mucosal lesions in patients with fixed orthodontic appliances. Medical Forum Monthly. 2016;27:12-5.
- Background Lau P, Wong R, editors. Risks and complications in orthodontic treatment, 2006.
- Background Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- Background LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Background Mahattanadul S, Mustafa MW, Kuadkaew S, Pattharachayakul S, Ungphaiboon S, Sawanyawisuth K. Oral ulcer healing and anti-Candida efficacy of an alcohol-free chitosan-curcumin mouthwash. Eur Rev Med Pharmacol Sci. 2018 Oct;22(20):7020-7023. doi: 10.26355/eurrev_201810_16173.
- Background McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb). 2012;22(3):276-82.
- Background Mohanty C, Sahoo SK. Curcumin and its topical formulations for wound healing applications. Drug Discov Today. 2017 Oct;22(10):1582-1592. doi: 10.1016/j.drudis.2017.07.001. Epub 2017 Jul 12.
- Background Mondal S, Ghosh S, Moulik SP. Stability of curcumin in different solvent and solution media: UV-visible and steady-state fluorescence spectral study. J Photochem Photobiol B. 2016 May;158:212-8. doi: 10.1016/j.jphotobiol.2016.03.004. Epub 2016 Mar 6.
- Background Nagpal M, Sood S. Role of curcumin in systemic and oral health: An overview. J Nat Sci Biol Med. 2013 Jan;4(1):3-7. doi: 10.4103/0976-9668.107253.
- Background Neville BW, Damm DD, Allen CM, Chi AC. Physical and Chemical Injuries. In: Oral & Maxillofacial Pathology. 4th ed. Elsevier: Missouri; 2016. p. 259-309.
- Background Noble J. Managing pain or discomfort caused by orthodontic appliances. J Can Dent Assoc. 2013;79:d45. No abstract available.
- Background Rebelo MAB, Correra de Queiroz A. Gingival Indices: State of Art, Gingival Diseases-Their Aetiology, Prevention and Treatment. Publisher: InTech. 2011:41-2.
- Background Rujirachotiwat A, Suttamanatwong S. Curcumin Promotes Collagen Type I, Keratinocyte Growth Factor-1, and Epidermal Growth Factor Receptor Expressions in the In Vitro Wound Healing Model of Human Gingival Fibroblasts. Eur J Dent. 2021 Feb;15(1):63-70. doi: 10.1055/s-0040-1715781. Epub 2020 Oct 1.
- Background Rujirachotiwat A and Suttamanatwong S. Effect of Curcuminonthe Expression of Wound Healing-related Genes in Human Gingival Fibroblasts.
- Background Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.
- Background Shamash MSA, Zaidan TF. Effect of topical curcumin on the healing of major oral mucosal ulceration. EurAsian Journal of BioSciences. 2020;14:4653-60.
- Background SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
- Background Smith PC, Martínez C. Wound Healing in the Oral Mucosa. In: Bergmeier LA, editor. In: Oral Mucosa in Health and Disease: A Concise Handbook. Cham: Springer International Publishing; 2018. p. 77-90.
- Background Soleimani V, Sahebkar A, Hosseinzadeh H. Turmeric (Curcuma longa) and its major constituent (curcumin) as nontoxic and safe substances: Review. Phytother Res. 2018 Jun;32(6):985-995. doi: 10.1002/ptr.6054. Epub 2018 Feb 26.
- Background Travess H, Roberts-Harry D, Sandy J. Orthodontics. Part 6: Risks in orthodontic treatment. Br Dent J. 2004 Jan 24;196(2):71-7. doi: 10.1038/sj.bdj.4810891.
- Background Zaher A, Elsabaa H, Abou Elkhier M, Elhindawy M. Impact of curcumin on tongue ulcer healing in albino rats. Mansoura J Dent. 2014;1:85-9.
- Results Akbari G, Setiani T, Malik I. Traumatic ulcer distribution of patiens with removable orthodontic appliance in Orthodontics Clinics of Dental Specialist Program. Padjadjaran Journal of Dentistry. 2014;26
- Results Al-Maweri SA, Alaizari N, Alharbi AA, Alotaibi SA, AlQuhal A, Almutairi BF, Alhuthaly S, Almutairi AM. Efficacy of curcumin for recurrent aphthous stomatitis: a systematic review. J Dermatolog Treat. 2022 May;33(3):1225-1230. doi: 10.1080/09546634.2020.1819529. Epub 2020 Sep 9.
- Results Asher C, Shaw WC. Benzydamine hydrochloride in the treatment of ulceration associated with recently placed fixed orthodontic appliances. Eur J Orthod. 1986 Feb;8(1):61-4. doi: 10.1093/ejo/8.1.61. No abstract available.
- Results Deshmukh RA, Bagewadi AS. Comparison of effectiveness of curcumin with triamcinolone acetonide in the gel form in treatment of minor recurrent aphthous stomatitis: A randomized clinical trial. Int J Pharm Investig. 2014 Jul;4(3):138-41. doi: 10.4103/2230-973X.138346.
- Results Kluemper GT, Hiser DG, Rayens MK, Jay MJ. Efficacy of a wax containing benzocaine in the relief of oral mucosal pain caused by orthodontic appliances. Am J Orthod Dentofacial Orthop. 2002 Oct;122(4):359-65. doi: 10.1067/mod.2002.126405.
- Results Kvam E, Bondevik O, Gjerdet NR. Traumatic ulcers and pain in adults during orthodontic treatment. Community Dent Oral Epidemiol. 1989 Jun;17(3):154-7. doi: 10.1111/j.1600-0528.1989.tb00012.x.
- Results Kvam E, Gjerdet NR, Bondevik O. Traumatic ulcers and pain during orthodontic treatment. Community Dent Oral Epidemiol. 1987 Apr;15(2):104-7. doi: 10.1111/j.1600-0528.1987.tb00493.x.
- Results Leiva-Cala C, Lorenzo-Pouso AI, Centenera-Centenera B, Lopez-Palafox J, Gandara-Vila P, Garcia-Garcia A, Perez-Sayans M. Clinical efficacy of an Aloe Vera gel versus a 0.12% chlorhexidine gel in preventing traumatic ulcers in patients with fixed orthodontic appliances: a double-blind randomized clinical trial. Odontology. 2020 Jul;108(3):470-478. doi: 10.1007/s10266-019-00468-w. Epub 2019 Oct 29.
- Results Mainali A. Occurrence of Oral Ulcerations in Patients undergoing Orthodontic Treatment: A Comparative study. Orthodontic Journal of Nepal. 2014;3.
- Results Manifar S, Obwaller A, Gharehgozloo A, Boorboor Shirazi Kordi H, Akhondzadeh S. Curcumin Gel in the Treatment of Minor Aphthous Ulcer: a Randomized, Placebo- Controlled Trial. J Med Plants. 2012;11(41):40-5.
- Results Patil K, Guledgud MV, Kulkarni PK, Keshari D, Tayal S. Use of Curcumin Mouthrinse in Radio-Chemotherapy Induced Oral Mucositis Patients: A Pilot Study. J Clin Diagn Res. 2015 Aug;9(8):ZC59-62. doi: 10.7860/JCDR/2015/13034.6345. Epub 2015 Aug 1.
- Results Rennick LA, Campbell PM, Naidu A, Taylor RW, Buschang PH. Effectiveness of a novel topical powder on the treatment of traumatic oral ulcers in orthodontic patients: A randomized controlled trial. Angle Orthod. 2016 May;86(3):351-7. doi: 10.2319/050415-303.1. Epub 2015 Sep 24.
- Results Sharma RA, Euden SA, Platton SL, Cooke DN, Shafayat A, Hewitt HR, Marczylo TH, Morgan B, Hemingway D, Plummer SM, Pirmohamed M, Gescher AJ, Steward WP. Phase I clinical trial of oral curcumin: biomarkers of systemic activity and compliance. Clin Cancer Res. 2004 Oct 15;10(20):6847-54. doi: 10.1158/1078-0432.CCR-04-0744.
- Results Shaw WC, Addy M, Griffiths S, Price C. Chlorhexidine and traumatic ulcers in orthodontic patients. Eur J Orthod. 1984 May;6(2):137-40. doi: 10.1093/ejo/6.2.137. No abstract available.
- Results Waghmare PF, Chaudhari AU, Karhadkar VM, Jamkhande AS. Comparative evaluation of turmeric and chlorhexidine gluconate mouthwash in prevention of plaque formation and gingivitis: a clinical and microbiological study. J Contemp Dent Pract. 2011 Jul 1;12(4):221-4. doi: 10.5005/jp-journals-10024-1038.
- Somprajob C, Auychai P, Chavanavesh J, Suttamanatwong S. Effectiveness of curcumin mouthwash in preventing traumatic ulcers in orthodontic patients. BMC Oral Health. 2025 Nov 3;25(1):1725. doi: 10.1186/s12903-025-07141-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Curcumin | Small molecule | 10 ml | Other |