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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат A- PRF
  A-PRF will be placed in one extraction socket

Первичные конечные точки

• Socket size using intra-oral scan [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• King AbdulAziz University — Jeddah

Публикации

• 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. PMID 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. PMID 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/cells121 PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 20373539

Идентификаторы

NCT: NCT07364890 · 120-11-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗