Application of Growth Factors Derived From Platelets to Accelerate Healing and Reduce Post-extraction Complications in Diabetic Individuals
NCT ID: NCT07287475
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
12 participants
INTERVENTIONAL
2025-12-01
2026-09-30
Brief Summary
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To compare healing between sockets treated with Advanced Platelet Rich Fibrin (A-PRF) vs. untreated control sites.
To assess post-operative discomfort and patient satisfaction.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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iPRF
Experimental: A- PRF in Extraction sockets in Diabetic patients. Arm Description: A randomized, double-blinded, split-mouth clinical trial was conducted at King Abdulaziz University Dental Hospital. Diabetic patients requiring bilateral extraction of the same tooth were enrolled. One socket was randomly assigned to receive A-PRF while the contralateral socket served as the control. Healing was assessed using digital intraoral scanning at baseline, 1 week, and 2 weeks post-extraction.
Platelet rich fibrin
Description: A-PRF is a biologically active scaffold that fits into the proven principles of the physiology of the wound-healing process. Its action lies in the controlled and prolonged release of fundamental factors like the PDGF (platelet-derived growth factor), TGF-β (transforming growth factor beta), and VEGF (vascular endothelial growth factor) which collectively enhance cellular migration, angiogenic events, and extracellular matrix remodeling factors of repair in the recovery of the tissues.
Control
Nothing was placed in the socket
No interventions assigned to this group
Interventions
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Platelet rich fibrin
Description: A-PRF is a biologically active scaffold that fits into the proven principles of the physiology of the wound-healing process. Its action lies in the controlled and prolonged release of fundamental factors like the PDGF (platelet-derived growth factor), TGF-β (transforming growth factor beta), and VEGF (vascular endothelial growth factor) which collectively enhance cellular migration, angiogenic events, and extracellular matrix remodeling factors of repair in the recovery of the tissues.
Eligibility Criteria
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Inclusion Criteria
* Need bilateral tooth extraction
* Sockets should be the same size
* Diabetic/ uncontrolled
* No other disease
* Non- smoker
* Non-pregnant or lactating female
Exclusion Criteria
* Patients with diseases different from diabetes
* Bleeding disorders
* Pregnancy
* Lactation,
* Tobacco use (conventional or electronic)
18 Years
ALL
No
Sponsors
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King Abdulaziz University
OTHER
Responsible Party
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Amal Jamjoom, BDS, MS.
Assistant Professor at KAU
Locations
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King AbdulAziz University
Jeddah, Mekkah, Saudi Arabia
Countries
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References
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1. Alwin Robert, A. and M.A. Al Dawish, Microvascular complications among patients with diabetes: An emerging health problem in Saudi Arabia. Diab Vasc Dis Res, 2019. 16(3): p. 227-235. 2. Kudiyirickal, M.G. and J.M. Pappachan, Diabetes mellitus and oral health. Endocrine, 2015. 49(1): p. 27-34. 3. Mohseni Homagarani, Y., et al., The effect of diabetes mellitus on oral health-related quality of life: A systematic review and meta-analysis study. Front Public Health, 2023. 11: p. 1112008. 4. Davis, V.L., et al., Platelet-rich preparations to improve healing. Part I: workable options for every size practice. J Oral Implantol, 2014. 40(4): p. 500-10. 5. Singh, N., D.G. Armstrong, and B.A. Lipsky, Preventing foot ulcers in patients with diabetes. Jama, 2005. 293(2): p. 217-28. 6. Al-Rubeaan, K., et al., Diabetic foot complications and their risk factors from a large retrospective cohort study. PLoS One, 2015. 10(5): p. e0124446. 7. Yoo, J.J., et al., The effect of diabetes on tooth loss caused by periodontal disease: A nationwide population-based cohort study in South Korea. J Periodontol, 2019. 90(6): p. 576-583. 8. Wang, Q., et al., Clinical analysis of medication related osteonecrosis of the jaws: A growing severe complication in China. J Dent Sci, 2018. 13(3): p. 190-197. 9. Ribeiro, L.M., et al., Streptococcus anginosus and Phalangeal Osteomyelitis: An Unusual Presentation. J Orthop Case Rep, 2020. 10(9): p. 19-22. 10. Gholinejad Ghadi, N., et al., [Not Available]. J Mycol Med, 2018. 28(2): p. 399-402. 11. Zhou, S., et al., The role of IFT140 in early bone healing of tooth extraction sockets. Oral Dis, 2022. 28(4): p. 1188-1197. 12. de Sousa Gomes, P., et al., Molecular and Cellular Aspects of Socket Healing in the Absence and Presence of Graft Materials and Autologous Platelet Concentrates: a Focused Review. J Oral Maxillofac Res, 2019. 10(3): p. e2. 13. Takahashi, S., et al., Lymphangiogenesis and NOS Localization in Healing Process
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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264-12-23
Identifier Type: -
Identifier Source: org_study_id