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

NCT07364890 | Not Yet Recruiting DMC

• 1 other identifier: 120-11-24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoke Exposure

Keywords

Smokers; A- PRF; Extraction; Socket

Outcome Measures

Primary Outcomes (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).

  3 weeks

Study Arms (2)

A- PRF in Extraction sockets in smokers

EXPERIMENTAL

A- PRF in Extraction sockets in smokers.

Drug: A- PRF

Control

NO INTERVENTION

Control site will not receive anything

Interventions

A- PRF DRUG

A-PRF will be placed in one extraction socket

Also known as: Advanced Platelet Rich Fibrin

A- PRF in Extraction sockets in smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King AbdulAziz University

Jeddah, Mekkah, 23422, Saudi Arabia

Location

Related Publications (30)

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Study Officials

• Amal G Jamjoom, MS

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Jamjoom, BDS, MS

CONTACT

+966500190435; agjamjoom@kau.edu.sa

Amal G Jamjoom, MS

CONTACT

0500190435; agjamjoom@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at KAU

Model Details: One extraction socket receives A-PRF and the contralateral side will act a a control.

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: January 23, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

SA (1)