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

December 13, 2025 updated by: Amal Jamjoom, BDS, MS., King Abdulaziz University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mekkah
      • Jeddah, Mekkah, Saudi Arabia, 23422
        • King Abdulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
No Intervention: Control
Nothing was placed in the socket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socket size
Time Frame: 3 weeks
Soft tissue healing of extraction sockets
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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