drugset / Trial / NCT05683782
Erythropoietin Gel as an Adjunct to Split-Thickness Apically Positioned Flap in Augmentation of Attached Gingiva
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will be carried out to evaluate the effect of topical application of erythropoietin gel as an adjunct to split-thickness apically positioned flap regarding Wound Healing and the Effect on post-surgical symptoms \[ Patient Satisfaction\] (1ry objective) and Clinical gain in width of attached gingiva. (2ry objective).
Timeline
- Start
- 2022-10-01
- Primary completion
- 2023-07
- Completion
- 2023-08
Publications
- Background Yaghobee S, Rouzmeh N, Taheri M, Aslroosta H, Mahmoodi S, Mohammadnejad Hardoroodi M, Soleimanzadeh Azar P, Khorsand A. Evaluation of topical erythropoietin application on the healing outcome of gingival graft recipient site; a randomized controlled clinical trial. BMC Oral Health. 2021 Nov 12;21(1):578. doi: 10.1186/s12903-021-01948-8.
- Background Yaghobee S, Rouzmeh N, Aslroosta H, Mahmoodi S, Khorsand A, Kharrazifard MJ. Effect of Topical Erythropoietin (EPO) on palatal wound healing subsequent to Free Gingival Grafting (FGG). Braz Oral Res. 2018 Jun 11;32:e55. doi: 10.1590/1807-3107bor-2018.vol32.0055.
- Background Rezazadeh M, Jafari N, Akbari V, Amirian M, Tabbakhian M, Minaiyan M, Rostami M. A mucoadhesive thermosensitive hydrogel containing erythropoietin as a potential treatment in oral mucositis: in vitro and in vivo studies. Drug Deliv Transl Res. 2018 Oct;8(5):1226-1237. doi: 10.1007/s13346-018-0566-9.
- Background Hamed S, Belokopytov M, Ullmann Y, Safadi M, Stark Y, Shoufani A, Akita S, Liu PY, Teot L. Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2019 Oct 1;8(10):514-521. doi: 10.1089/wound.2018.0808. Epub 2019 Aug 21.
- Background Brines M, Cerami A. Erythropoietin-mediated tissue protection: reducing collateral damage from the primary injury response. J Intern Med. 2008 Nov;264(5):405-32. doi: 10.1111/j.1365-2796.2008.02024.x.
- Background Carnio J, Miller PD Jr. Increasing the amount of attached gingiva using a modified apically repositioned flap. J Periodontol. 1999 Sep;70(9):1110-7. doi: 10.1902/jop.1999.70.9.1110.
- Background Carnio J, Camargo PM, Passanezi E. Increasing the apico-coronal dimension of attached gingiva using the modified apically repositioned flap technique: a case series with a 6-month follow-up. J Periodontol. 2007 Sep;78(9):1825-30. doi: 10.1902/jop.2007.060414.
- Background Buemi M, Galeano M, Sturiale A, Ientile R, Crisafulli C, Parisi A, Catania M, Calapai G, Impala P, Aloisi C, Squadrito F, Altavilla D, Bitto A, Tuccari G, Frisina N. Recombinant human erythropoietin stimulates angiogenesis and healing of ischemic skin wounds. Shock. 2004 Aug;22(2):169-73. doi: 10.1097/01.shk.0000133591.47776.bd.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epoetin alfa | Protein / enzyme biologic | 4000 iu | Topical |
Indications
No indication recorded.