Application of Growth Factors Derived From Platelets to Accelerate Healing and Reduce Post-extraction Complications in Diabetic Individuals

NCT07287475 | Enrolling By Invitation DMC

• 1 other identifier: 264-12-23
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate soft tissue closure in diabetic extraction sockets using digital scans. 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.

Conditions

Diabete Mellitus

Keywords

Diabetic; A-PRF; Extraction; Socket

Outcome Measures

Primary Outcomes (1)

• Socket size

  Soft tissue healing of extraction sockets

  3 weeks

Study Arms (2)

iPRF

OTHER

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.

Procedure: Platelet rich fibrin

Control

NO INTERVENTION

Nothing was placed in the socket

Interventions

Platelet rich fibrin PROCEDURE

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.

iPRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen years or older
• Need bilateral tooth extraction
• Sockets should be the same size
• Diabetic/ uncontrolled
• No other disease
• Non- smoker
• Non-pregnant or lactating female

You may not qualify if:

• Patients below 18 years
• Patients with diseases different from diabetes
• Bleeding disorders
• Pregnancy
• Lactation,
• Tobacco use (conventional or electronic)

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King AbdulAziz University

Jeddah, Mekkah, 23422, Saudi Arabia

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at KAU

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 17, 2025
• Study Start: December 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

SA (1)