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

January 18, 2026 updated by: Amal Jamjoom, BDS, MS., King Abdulaziz University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

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 Contact

Study Contact Backup

Study Locations

  • Saudi Arabia
    • 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:

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

Exclusion Criteria:

  • 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.

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
Experimental: A- PRF in Extraction sockets in smokers
A- PRF in Extraction sockets in smokers.
Drug: A- PRF
A-PRF will be placed in one extraction socket
Other Names:
  • Advanced Platelet Rich Fibrin
No Intervention: Control
Control site will not receive anything

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socket size using intra-oral scan
Time Frame: 3 weeks
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).
3 weeks

Collaborators and Investigators

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

Sponsor

King Abdulaziz University

Investigators

  • Principal Investigator: Amal G Jamjoom, MS, King Abdulaziz University

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

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 (Estimated)

January 31, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 13, 2025

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 120-11-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

PD will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years thereafter.

IPD Sharing Access Criteria

Access to de-identified individual participant data will be granted to qualified researchers who submit a scientifically sound proposal outlining the research objectives and planned analyses. Requests will be reviewed by the principal investigator to ensure alignment with the original study aims, ethical approval, and data protection requirements. Approved applicants will be required to sign a data use agreement prior to data release. Data will be provided in a secure, de-identified format and used solely for the approved purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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