Diabete MellitusNCT07287475
Application of Growth Factors Derived From Platelets to Accelerate Healing and Reduce Post-extraction Complications in Diabetic Individuals
A study testing Platelet rich fibrin in people with Diabete Mellitus, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- Platelet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients below 18 years
- Patients with diseases different from diabetes
- Bleeding disorders
- Pregnancy
- Lactation,
- Tobacco use (conventional or electronic)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Platelet rich fibrin
- Keywords
- Diabetic, A-PRF, Extraction, Socket
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Platelet rich fibrin |
| Control | No intervention | Nothing was placed in the socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socket size
Soft tissue healing of extraction sockets
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Dec 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Jamjoom, BDS, MS., King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287475
- Sponsor's protocol ID
- 264-12-23
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Growth Factors Derived From Platelets to Accelerate Healing and Reduce Post-extraction Complications in Diabetic Individuals
- ClinicalTrials.gov ID
- NCT07287475
- Acronym / sponsor ID
- 264-12-23
- Conditions
- Diabete Mellitus
- Keywords
- Diabetic, A-PRF, Extraction, Socket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPRF | Other | Procedure: Platelet rich fibrinExperimental: 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. |
| Control | No intervention | –Nothing was placed in the socket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eighteen years or older
- Need bilateral tooth extraction
- Sockets should be the same size
- Diabetic/ uncontrolled
- No other disease
Key exclusion criteria (6 listed)
- Patients below 18 years
- Patients with diseases different from diabetes
- Bleeding disorders
- Pregnancy
- Lactation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich fibrinDescription: 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. | Procedure or surgery | iPRF |
Primary outcome
Socket size
Time frame: 3 weeks
Soft tissue healing of extraction sockets
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background1. 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
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich fibrin in people with Diabete Mellitus, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socket size (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07287475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.