drugset / Trial / NCT07867236
Assessment of Osteogenic Potential of Topical Metformin Gel on Bone Regeneration in Cystic Jaw Defects: Randomized Controlled Clinical Trial
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation
Timeline
- Start
- 2026-10-30
- Primary completion
- 2027-09-30
- Completion
- 2027-10-30
Publications
- Background Fontana F, Maschera E, Rocchietta I, Simion M. Clinical classification of complications in guided bone regeneration procedures by means of a nonresorbable membrane. Int J Periodontics Restorative Dent. 2011 Jun;31(3):265-73.
- Background Kang YJ, Kim MK, Kim SG, Park YW, Oh JH. Predicting Risk Factors for Complications in Jaw Cyst Treatment: Insights from a Retrospective Study. J Korean Assoc Oral Maxillofac Surg. 2025 Feb 28;51(1):33-40. doi: 10.5125/jkaoms.2025.51.1.33.
- Background Shokry MMEM, Melek LNF, Amer TA. Three-dimensional volumetric analysis of bone regeneration following jaw cyst enucleation with and without an autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF): a randomized controlled clinical trial. BMC Oral Health. 2025 May 8;25(1):693. doi: 10.1186/s12903-025-06027-w.
- Background Chacko R, Kumar S, Paul A, Arvind. Spontaneous Bone Regeneration After Enucleation of Large Jaw Cysts: A Digital Radiographic Analysis of 44 Consecutive Cases. J Clin Diagn Res. 2015 Sep;9(9):ZC84-9. doi: 10.7860/JCDR/2015/13394.6524. Epub 2015 Sep 1.
- Background Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
- Background Lingamaneni S, Mandadi LR, Pathakota KR. Assessment of healing following low-level laser irradiation after gingivectomy operations using a novel soft tissue healing index: A randomized, double-blind, split-mouth clinical pilot study. J Indian Soc Periodontol. 2019 Jan-Feb;23(1):53-57. doi: 10.4103/jisp.jisp_226_18.
- Background Kim HY, Lee SM, Park JH, Kim SJ. Three-dimensional analysis of decompression efficacy and influencing factors in the maxillofacial cystic lesions: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Aug 31;50(4):197-205. doi: 10.5125/jkaoms.2024.50.4.197.
- Background Sabbagh M, Khairallah CM, Saleh A, Chaanine C. Volumetric Radiological Analysis of Bone Regeneration After Jaw Cyst Enucleation Without Grafting Material: A Retrospective Pilot Study. Cureus. 2025 Oct 1;17(10):e93636. doi: 10.7759/cureus.93636. eCollection 2025 Oct.
- Background Montalban-Vadillo O, Perez-Pevida E, Viteri-Agustin I, Chavarri-Prado D, Estrada-Martinez A, Dieguez-Pereira M, Sanchez-Lasheras F, Brizuela-Velasco A. Effect of Applying 1% Metformin on Guided Bone Regeneration Processes with Bovine-Derived Xenografts. J Clin Med. 2024 May 18;13(10):2973. doi: 10.3390/jcm13102973.
- Background Pradeep AR, Patnaik K, Nagpal K, Karvekar S, Guruprasad CN, Kumaraswamy KM. Efficacy of 1% Metformin Gel in Patients With Moderate and Severe Chronic Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Oct;88(10):1023-1029. doi: 10.1902/jop.2017.150096. Epub 2017 Jul 21.
- Background Wang P, Ma T, Guo D, Hu K, Shu Y, Xu HHK, Schneider A. Metformin induces osteoblastic differentiation of human induced pluripotent stem cell-derived mesenchymal stem cells. J Tissue Eng Regen Med. 2018 Feb;12(2):437-446. doi: 10.1002/term.2470. Epub 2017 Aug 11.
- Background Vestergaard P, Rejnmark L, Mosekilde L. Relative fracture risk in patients with diabetes mellitus, and the impact of insulin and oral antidiabetic medication on relative fracture risk. Diabetologia. 2005 Jul;48(7):1292-9. doi: 10.1007/s00125-005-1786-3. Epub 2005 May 21.
- Background Gao Y, Xue J, Li X, Jia Y, Hu J. Metformin regulates osteoblast and adipocyte differentiation of rat mesenchymal stem cells. J Pharm Pharmacol. 2008 Dec;60(12):1695-700. doi: 10.1211/jpp.60/12.0017.
- Background LeGeros RZ. Properties of osteoconductive biomaterials: calcium phosphates. Clin Orthop Relat Res. 2002 Feb;(395):81-98. doi: 10.1097/00003086-200202000-00009.
- Background Makki AZ, Alsulami AM, Almatrafi AS, Sindi MZ, Sembawa SN. The Effectiveness of Advanced Platelet-Rich Fibrin in comparison with Leukocyte-Platelet-Rich Fibrin on Outcome after Dentoalveolar Surgery. Int J Dent. 2021 May 8;2021:6686857. doi: 10.1155/2021/6686857. eCollection 2021.
- Background Campana V, Milano G, Pagano E, Barba M, Cicione C, Salonna G, Lattanzi W, Logroscino G. Bone substitutes in orthopaedic surgery: from basic science to clinical practice. J Mater Sci Mater Med. 2014 Oct;25(10):2445-61. doi: 10.1007/s10856-014-5240-2. Epub 2014 May 28.
- Background Stoelinga PJ. The management of aggressive cysts of the jaws. J Maxillofac Oral Surg. 2012 Mar;11(1):2-12. doi: 10.1007/s12663-012-0347-9. Epub 2012 Mar 11.
- Background Wang J, Yao QY, Zhu HY. Efficacy of bone grafts in jaw cystic lesions: A systematic review. World J Clin Cases. 2022 Mar 26;10(9):2801-2810. doi: 10.12998/wjcc.v10.i9.2801.
- Results Du C, Wang Z, Lan D, Zhu R, Wang D, Wang H, Wan C, Gao T, Han R, Liu L, Zhang K. Clinical analysis of 1,038 cases of odontogenic jawbone cysts. BMC Oral Health. 2024 Nov 15;24(1):1387. doi: 10.1186/s12903-024-05167-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 10 mg/ml | Other |