Effectiveness of a novel topical powder on the treatment of traumatic oral ulcers in orthodontic patients: A randomized controlled trial
Lauren A Rennick, Phillip M Campbell, Aparna Naidu, Reginald W Taylor, Peter H Buschang, Lauren A Rennick, Phillip M Campbell, Aparna Naidu, Reginald W Taylor, Peter H Buschang
Abstract
Objective: To determine if 2-DeNT Oral Topical Powder is an effective treatment for traumatic oral ulcers.
Materials and methods: Of the 46 patients who were randomly allocated, 20 patients from the experimental group and 17 from the placebo control group completed the study. The patients, operators, and evaluators were all blinded. Patients applied the powder twice a day and completed a diary twice a day for 10 days. The diary was used to monitor the size of the lesions and pain levels (using a 10-cm visual analog scale).
Results: By day 5, the ulcers in the experimental group had reduced in size by approximately 70%; and ulcers in the control group had reduced in size by 56%. The experimental-group ulcers were significantly (P < .05) smaller than the control-group ulcers from day 5 through day 9. Ulcers in the experimental group were completely resolved by day 8, whereas control-group ulcers were still present on day 10. Patients experienced a significant amount of stimulated pain until the night of day 2 in the experimental group and until the night of day 5 in the control group, but group differences in pain were not statistically significant.
Conclusions: The 2DeNT Oral Topical powder was more effective than the placebo powder at accelerating the healing of oral traumatic ulcers.
Keywords: Duration; Pain; Traumatic oral ulcers; Treatment; Ulcer size.
Figures
![Figure 1.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8601726/bin/i0003-3219-86-3-351-f01.jpg)
![Figure 2.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8601726/bin/i0003-3219-86-3-351-f02.jpg)
![Figure 3.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8601726/bin/i0003-3219-86-3-351-f03.jpg)
![Figure 4.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8601726/bin/i0003-3219-86-3-351-f04.jpg)
Figure 5.
Rates of ulcer size change…
Figure 5.
Rates of ulcer size change based on the multilevel estimates.
Figure 6.
Percentages of patients with complete…
Figure 6.
Percentages of patients with complete ulcer resolution, along with significant (P
Figure 7.
Pain when the ulcer is…
Figure 7.
Pain when the ulcer is touched as recorded each morning (M) and night…
- Management of denture-related traumatic ulcers using ozone.AlZarea BK. AlZarea BK. J Prosthet Dent. 2019 Jan;121(1):76-82. doi: 10.1016/j.prosdent.2018.03.015. Epub 2018 Aug 7. J Prosthet Dent. 2019. PMID: 30093125
- Topical sucralfate decreases pain after hemorrhoidectomy and improves healing: a randomized, blinded, controlled study.Gupta PJ, Heda PS, Kalaskar S, Tamaskar VP. Gupta PJ, et al. Dis Colon Rectum. 2008 Feb;51(2):231-4. doi: 10.1007/s10350-007-9092-4. Epub 2007 Dec 18. Dis Colon Rectum. 2008. PMID: 18095028 Clinical Trial.
- Topical phenytoin versus EUSOL in the treatment of non-malignant chronic leg ulcers.Carneiro PM, Nyawawa ET. Carneiro PM, et al. East Afr Med J. 2003 Mar;80(3):124-9. doi: 10.4314/eamj.v80i3.8680. East Afr Med J. 2003. PMID: 12762426 Clinical Trial.
- The efficacy of topical 0.2% hyaluronic acid gel on recurrent oral ulcers: comparison between recurrent aphthous ulcers and the oral ulcers of Behçet's disease.Lee JH, Jung JY, Bang D. Lee JH, et al. J Eur Acad Dermatol Venereol. 2008 May;22(5):590-5. doi: 10.1111/j.1468-3083.2007.02564.x. Epub 2007 Dec 17. J Eur Acad Dermatol Venereol. 2008. PMID: 18093111 Clinical Trial.
- Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration.O'Meara S, Cullum N, Majid M, Sheldon T. O'Meara S, et al. Health Technol Assess. 2000;4(21):1-237. Health Technol Assess. 2000. PMID: 11074391 Review.
- Clinical Performance Evaluation of a Hyaluronic Acid Dental Gel for the Treatment of Traumatic Ulcers in Patients with Fixed Orthodontic Appliances: A Randomized Controlled Trial.Tremolati M, Farronato M, Ferrantino L, Rusconi F, Lodi G, Maspero C. Tremolati M, et al. Bioengineering (Basel). 2022 Dec 3;9(12):761. doi: 10.3390/bioengineering9120761. Bioengineering (Basel). 2022. PMID: 36550967 Free PMC article.
- Evaluation of zinc sulfate mucoadhesive formulation on recurrent aphthous stomatitis: a randomized double-blind, placebo-controlled clinical trial.Ghorbani A, Akbari J, Boorboor M, Nekoukar Z, Eslami G. Ghorbani A, et al. BMC Oral Health. 2020 Jul 28;20(1):212. doi: 10.1186/s12903-020-01194-4. BMC Oral Health. 2020. PMID: 32723352 Free PMC article. Clinical Trial.
- Medicinal Signaling Cells Metabolite Oral Based as a Potential Biocompatible Biomaterial Accelerating Oral Ulcer Healing (In Vitro Study).Nugraha AP; Purwati; Susilowati H, Hendrianto E, Karsari D, Ertanti N, Dinaryanti A, Ihsan IS, Narmada IB, Ernawati DS, Rantam FA. Nugraha AP, et al. Eur J Dent. 2019 Jul;13(3):432-436. doi: 10.1055/s-0039-1693923. Epub 2019 Dec 3. Eur J Dent. 2019. PMID: 31795007 Free PMC article.
- Prostanoid-dependent spontaneous pain and PAR2-dependent mechanical allodynia following oral mucosal trauma: involvement of TRPV1, TRPA1 and TRPV4.Ito M, Ono K, Hitomi S, Nodai T, Sago T, Yamaguchi K, Harano N, Gunnjigake K, Hosokawa R, Kawamoto T, Inenaga K. Ito M, et al. Mol Pain. 2017 Jan;13:1744806917704138. doi: 10.1177/1744806917704138. Mol Pain. 2017. PMID: 28381109 Free PMC article.
- Current advances in orthodontic pain.Long H, Wang Y, Jian F, Liao LN, Yang X, Lai WL. Long H, et al. Int J Oral Sci. 2016 Jun 30;8(2):67-75. doi: 10.1038/ijos.2016.24. Int J Oral Sci. 2016. PMID: 27341389 Free PMC article. Review.
- Randomized Controlled Trial
- Administration, Topical
- Adolescent
- Adult
- Child
- Female
- Humans
- Male
- Oral Ulcer / drug therapy*
- Pain
- Pain Measurement
- Treatment Outcome
- Wound Healing*
- Young Adult
- Full Text Sources
- Medical
NCBI Literature Resources
The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.
National Library of Medicine
8600 Rockville Pike
Bethesda, MD 20894
![Figure 5.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8601726/bin/i0003-3219-86-3-351-f05.jpg)
![Figure 6.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8601726/bin/i0003-3219-86-3-351-f06.jpg)
Figure 7.
Pain when the ulcer is…
Figure 7.
Pain when the ulcer is touched as recorded each morning (M) and night…
- Management of denture-related traumatic ulcers using ozone.AlZarea BK. AlZarea BK. J Prosthet Dent. 2019 Jan;121(1):76-82. doi: 10.1016/j.prosdent.2018.03.015. Epub 2018 Aug 7. J Prosthet Dent. 2019. PMID: 30093125
- Topical sucralfate decreases pain after hemorrhoidectomy and improves healing: a randomized, blinded, controlled study.Gupta PJ, Heda PS, Kalaskar S, Tamaskar VP. Gupta PJ, et al. Dis Colon Rectum. 2008 Feb;51(2):231-4. doi: 10.1007/s10350-007-9092-4. Epub 2007 Dec 18. Dis Colon Rectum. 2008. PMID: 18095028 Clinical Trial.
- Topical phenytoin versus EUSOL in the treatment of non-malignant chronic leg ulcers.Carneiro PM, Nyawawa ET. Carneiro PM, et al. East Afr Med J. 2003 Mar;80(3):124-9. doi: 10.4314/eamj.v80i3.8680. East Afr Med J. 2003. PMID: 12762426 Clinical Trial.
- The efficacy of topical 0.2% hyaluronic acid gel on recurrent oral ulcers: comparison between recurrent aphthous ulcers and the oral ulcers of Behçet's disease.Lee JH, Jung JY, Bang D. Lee JH, et al. J Eur Acad Dermatol Venereol. 2008 May;22(5):590-5. doi: 10.1111/j.1468-3083.2007.02564.x. Epub 2007 Dec 17. J Eur Acad Dermatol Venereol. 2008. PMID: 18093111 Clinical Trial.
- Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration.O'Meara S, Cullum N, Majid M, Sheldon T. O'Meara S, et al. Health Technol Assess. 2000;4(21):1-237. Health Technol Assess. 2000. PMID: 11074391 Review.
- Clinical Performance Evaluation of a Hyaluronic Acid Dental Gel for the Treatment of Traumatic Ulcers in Patients with Fixed Orthodontic Appliances: A Randomized Controlled Trial.Tremolati M, Farronato M, Ferrantino L, Rusconi F, Lodi G, Maspero C. Tremolati M, et al. Bioengineering (Basel). 2022 Dec 3;9(12):761. doi: 10.3390/bioengineering9120761. Bioengineering (Basel). 2022. PMID: 36550967 Free PMC article.
- Evaluation of zinc sulfate mucoadhesive formulation on recurrent aphthous stomatitis: a randomized double-blind, placebo-controlled clinical trial.Ghorbani A, Akbari J, Boorboor M, Nekoukar Z, Eslami G. Ghorbani A, et al. BMC Oral Health. 2020 Jul 28;20(1):212. doi: 10.1186/s12903-020-01194-4. BMC Oral Health. 2020. PMID: 32723352 Free PMC article. Clinical Trial.
- Medicinal Signaling Cells Metabolite Oral Based as a Potential Biocompatible Biomaterial Accelerating Oral Ulcer Healing (In Vitro Study).Nugraha AP; Purwati; Susilowati H, Hendrianto E, Karsari D, Ertanti N, Dinaryanti A, Ihsan IS, Narmada IB, Ernawati DS, Rantam FA. Nugraha AP, et al. Eur J Dent. 2019 Jul;13(3):432-436. doi: 10.1055/s-0039-1693923. Epub 2019 Dec 3. Eur J Dent. 2019. PMID: 31795007 Free PMC article.
- Prostanoid-dependent spontaneous pain and PAR2-dependent mechanical allodynia following oral mucosal trauma: involvement of TRPV1, TRPA1 and TRPV4.Ito M, Ono K, Hitomi S, Nodai T, Sago T, Yamaguchi K, Harano N, Gunnjigake K, Hosokawa R, Kawamoto T, Inenaga K. Ito M, et al. Mol Pain. 2017 Jan;13:1744806917704138. doi: 10.1177/1744806917704138. Mol Pain. 2017. PMID: 28381109 Free PMC article.
- Current advances in orthodontic pain.Long H, Wang Y, Jian F, Liao LN, Yang X, Lai WL. Long H, et al. Int J Oral Sci. 2016 Jun 30;8(2):67-75. doi: 10.1038/ijos.2016.24. Int J Oral Sci. 2016. PMID: 27341389 Free PMC article. Review.
- Randomized Controlled Trial
- Administration, Topical
- Adolescent
- Adult
- Child
- Female
- Humans
- Male
- Oral Ulcer / drug therapy*
- Pain
- Pain Measurement
- Treatment Outcome
- Wound Healing*
- Young Adult
- Full Text Sources
- Medical
![Figure 7.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8601726/bin/i0003-3219-86-3-351-f07.jpg)
Source: PubMed