Platelet-Derived Growth Factors to Enhance Healing and Reduce Post-Extraction Complications in Smokers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- King Abdulaziz University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Socket size using intra-oral scan
Study Overview
Brief 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. 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
A- PRF in Extraction sockets in smokers
A- PRF in Extraction sockets in smokers.
Intervention: A- PRF (Drug)
Control
Control site will not receive anything
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Amal Jamjoom, BDS, MS.
Assistant Professor at KAU
King Abdulaziz University