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Smoke ExposureNCT07364890

Platelet-Derived Growth Factors to Enhance Healing and Reduce Post-Extraction Complications in Smokers

A study testing A- PRF in people with Smoke Exposure, run by King Abdulaziz University at 1 site in Saudi Arabia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a randomized controlled clinical trial with a split-mouth design to evaluate the effect of Advanced Platelet-Rich Fibrin (A-PRF) application on socket healing following dental extractions in smokers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoke Exposure
What is being tested?
A- PRF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSaudi Arabia
Study dates
12 Feb 2026to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Smokers
  • Aged 18 years or older
  • Actively smoking at least 10 cigarettes per day
  • Requiring bilateral extractions.

Who cannot join

  • Patients younger than 18 years
  • Diabetes mellitus
  • Hypertension
  • Bleeding disorders
  • Pregnant or lactating women
  • Individuals who used tobacco products other than conventional cigarettes (such as e-cigarettes or waterpipes) were excluded.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • King AbdulAziz University

    Jeddah, Mekkah, 23422

Other trials in Saudi Arabia

About this study

This study is a randomized controlled clinical trial with a split-mouth design to evaluate the effect of Advanced Platelet-Rich Fibrin (A-PRF) application on socket healing following dental extractions in smokers. In the split-mouth design, each participant serves as their own control, minimizing inter-subject variability and controlling for potential confounders such as smoking habits, oral hygiene, and systemic health conditions.

Bilateral tooth extractions will be performed for each participant, with one extraction site randomly assigned to receive socket preservation using an A-PRF plug, while the contralateral site will be left to heal naturally without intervention.

The study will be conducted at the Faculty of Dentistry and the University Dental Hospital, King Abdulaziz University, Jeddah, Saudi Arabia. Recruitment began in December 2025 and will continue until the targeted sample size is achieved.

Read the detailed description

Participants will be recruited using a convenience sampling approach from the College of Dentistry and the University Dental Hospital at King Abdulaziz University, Jeddah, Saudi Arabia.

Patients requiring bilateral tooth extractions and initially appearing eligible based on their medical records will be identified. Eligibility will be further confirmed through direct interviews to verify smoking habits (≥10 cigarettes per day) and to ensure compliance with the inclusion and exclusion criteria.

Patients who meet the eligibility requirements will be informed about the nature and purpose of the study, and those who agree to participate will provide written informed consent.

Following recruitment, each participant will have one extraction site randomly assigned to receive A-PRF treatment (intervention), while the contralateral site will serve as the control, according to a split-mouth design. Recruitment will commence in January 2026 and will continue until the planned sample size is achieved. Here is the fully converted future-tense version, polished and suitable for a study protocol / PRS / methods section:

All dental extractions will be performed by a periodontist under local anesthesia (2% lidocaine with 1:100,000 epinephrine) using simple atraumatic techniques to preserve the socket architecture and minimize trauma to the surrounding soft and hard tissues. No surgical extractions will be performed.

A-PRF will be prepared immediately after tooth extraction. Intravenous blood samples will be collected from each participant using sterile glass-coated 9-mL tubes without an anticoagulant. The blood samples will be processed immediately by centrifugation at 1300 rpm for 14 minutes to obtain Advanced Platelet-Rich Fibrin (A-PRF).

Following centrifugation, the fibrin clots will be carefully separated from the red blood cell layer, transferred to a PRF box, and gently compressed into plugs.

At the intervention sites, the prepared A-PRF plugs will be gently adapted into the extraction socket immediately after tooth removal and stabilized using a figure-of-eight suture to secure the material and protect the healing site. At the control sites, no A-PRF will be placed; only a figure-of-eight suture will be applied to stabilize the blood clot and support natural healing.

Standard postoperative instructions will be provided to all participants to promote optimal healing and minimize postoperative complications.

Intraoral digital scans will be performed to assess soft-tissue healing immediately after extraction and at 7 and 14 days post-extraction. Participants will also be asked to complete a patient-reported experience questionnaire at one week and again at the time of suture removal (two weeks post-extraction).

Conditions
Smoke Exposure
Being tested
A- PRF
Keywords
Smokers, A- PRF, Extraction, Socket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A- PRFDrug

    Also called Advanced Platelet Rich Fibrin

    A-PRF will be placed in one extraction socket

Study groups in NCT07364890
Study groupRoleWhat they receive
A- PRF in Extraction sockets in smokersExperimentalA- PRF in Extraction sockets in smokers.
Receives: Drug: A- PRF
ControlNo interventionControl site will not receive anything

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Socket size using intra-oral scan

    Socket size will be measured using intra-oral digital scanning. Three-dimensional scans of the extraction site will be obtained and analyzed using digital software to delineate socket margins and calculate the socket surface area (mm²).

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start12 Feb 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

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
Model description
One extraction socket receives A-PRF and the contralateral side will act a a control.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364890
Sponsor's protocol ID
120-11-24
Status last verified
Jan 2026
First submitted
13 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: De-identified individual participant data (IPD) underlying the results reported in publications arising from this study will be shared. This will include demographic variables, smoking status, clinical outcomes related to soft tissue healing, intraoral scan measurements, and patient-reported outcome questionnaire data. No identifiable information will be shared.

Publications

  • Yerke LM, Jamjoom A, Zahid TM, Cohen RE. The Effect of Platelet-Rich Fibrin, Calcium Sulfate Hemihydrate, Platelet-Rich Plasma and Resorbable Collagen on Soft Tissue Closure of Extraction Sites. J Funct Biomater. 2017 May 25;8(2):17. doi: 10.3390/jfb8020017.

    PubMed 28587096
  • Pan J, Xu Q, Hou J, Wu Y, Liu Y, Li R, Pan Y, Zhang D. Effect of platelet-rich fibrin on alveolar ridge preservation: A systematic review. J Am Dent Assoc. 2019 Sep;150(9):766-778. doi: 10.1016/j.adaj.2019.04.025.

    PubMed 31439204
  • Malcangi G, Patano A, Palmieri G, Di Pede C, Latini G, Inchingolo AD, Hazballa D, de Ruvo E, Garofoli G, Inchingolo F, Dipalma G, Minetti E, Inchingolo AM. Maxillary Sinus Augmentation Using Autologous Platelet Concentrates (Platelet-Rich Plasma, Platelet-Rich Fibrin, and Concentrated Growth Factor) Combined with Bone Graft: A Systematic Review. Cells. 2023 Jul 6;12(13):1797. doi: 10.3390/cells12131797.

    PubMed 37443831
  • El Bagdadi K, Kubesch A, Yu X, Al-Maawi S, Orlowska A, Dias A, Booms P, Dohle E, Sader R, Kirkpatrick CJ, Choukroun J, Ghanaati S. Reduction of relative centrifugal forces increases growth factor release within solid platelet-rich-fibrin (PRF)-based matrices: a proof of concept of LSCC (low speed centrifugation concept). Eur J Trauma Emerg Surg. 2019 Jun;45(3):467-479. doi: 10.1007/s00068-017-0785-7. Epub 2017 Mar 21.

    PubMed 28324162
  • Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

    PubMed 16504852
  • Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.

    PubMed 16504850
  • Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.

    PubMed 19187989
  • Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. doi: 10.1902/jop.2009.090531.

    PubMed 20373539
  • Alshehri, A., et al., Assessment of the low-speed centrifugation concept modified in the release of fibroblast growth factor-2 in Saudi healthy patient. Saudi Journal of Oral Sciences, 2020. 7(3): p. 169-173.

  • Fujioka-Kobayashi M, Miron RJ, Hernandez M, Kandalam U, Zhang Y, Choukroun J. Optimized Platelet-Rich Fibrin With the Low-Speed Concept: Growth Factor Release, Biocompatibility, and Cellular Response. J Periodontol. 2017 Jan;88(1):112-121. doi: 10.1902/jop.2016.160443. Epub 2016 Sep 2.

    PubMed 27587367
  • Lalla E, Papapanou PN. Diabetes mellitus and periodontitis: a tale of two common interrelated diseases. Nat Rev Endocrinol. 2011 Jun 28;7(12):738-48. doi: 10.1038/nrendo.2011.106.

    PubMed 21709707
  • Souto-Maior JR, Pellizzer EP, de Luna Gomes JM, Dds CAAL, Dds JFSJ, Vasconcelos BCDE, de Moraes SLD. Influence of Diabetes on the Survival Rate and Marginal Bone Loss of Dental Implants: An Overview of Systematic Reviews. J Oral Implantol. 2019 Aug;45(4):334-340. doi: 10.1563/aaid-joi-D-19-00087. Epub 2019 May 1.

    PubMed 31042455
  • Mealey BL, Ocampo GL. Diabetes mellitus and periodontal disease. Periodontol 2000. 2007;44:127-53. doi: 10.1111/j.1600-0757.2006.00193.x. No abstract available.

    PubMed 17474930
  • De Angelis P, Manicone PF, Gasparini G, De Filippis I, Liguori MG, De Angelis S, Cannata F, D'Addona A. The Effect of Controlled Diabetes and Hyperglycemia on Implant Placement with Simultaneous Horizontal Guided Bone Regeneration: A Clinical Retrospective Analysis. Biomed Res Int. 2021 Jun 14;2021:9931505. doi: 10.1155/2021/9931505. eCollection 2021.

    PubMed 34222488
  • Power DJ, Sambrook PJ, Goss AN. The healing of dental extraction sockets in insulin-dependent diabetic patients: a prospective controlled observational study. Aust Dent J. 2019 Mar;64(1):111-116. doi: 10.1111/adj.12669. Epub 2019 Jan 2.

    PubMed 30525221

Questions about this trial

What is this clinical trial studying?

A study testing A- PRF in people with Smoke Exposure, 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 4 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: under way, not looking for participants, 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?

This study is still under way. Results are not available in the source record yet.

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 using intra-oral scan (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 NCT07364890, which also lists 30 linked publications.

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.

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