- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287475
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 264-12-23
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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