Topical Application of PRF Before Radiation Therapy
PRF
Topical Application of PRF in Tooth Extraction Sockets Before Radiation Therapy for Head and Neck Cancer
1 other identifier
interventional
34
1 country
1
Brief Summary
The primary goal of this study is to observe whether PRP promotes the wound healing before a radiation therapy or not, compared to the natural healing of a tooth extraction socket. Secondary aim is to monitore the effect on the pain perception.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 6, 2024
CompletedFirst Posted
Study publicly available on registry
May 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedApril 11, 2025
April 1, 2025
1.7 years
May 6, 2024
April 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing between the two sites using the Wound Healing Index
To compare the wound heeling, a modified Landry and Turnbull Healing Index is used. This index varies from 0 to 5, where 0 means no healing and 5 excellent healing.
around 4 Weeks
Secondary Outcomes (1)
PRF and Pain perception
around 7 days
Study Arms (2)
PRF site (test site)
EXPERIMENTALThe participants become at least two teeth removed, one site is applied with PRF (test site) while the other is left for natural healing by forming a blood clot (control site). Operator and Investigator as well as the Patient are blinded to to the site of application.
Blood clot (control site)
ACTIVE COMPARATORThe participants become at least two teeth removed, one site is applied with PRF (test site) while the other is left for natural healing by forming a blood clot (control site). Operator and Investigator as well as the Patient are blinded to to the site of application.
Interventions
Patients blood is standardized centrifuged and split in to a red-phase (erythrocytes) and white-phase (PRF). The gained PRF is processed to a clot-fort and is inserted into the alveolus.
After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.
Eligibility Criteria
You may qualify if:
- Head and neck cancer with planed radiation therapy
- Bilateral tooth extraction
- Similar tooth size
- Atraumatic tooth extractions without flap surgery
- Patients age above 18y of age
You may not qualify if:
- Prior radiation therapy in the head and neck area
- Prior and current therapy with bisphosphonates or equivalent modern biologics
- Patients during pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Giessen
Giessen, Hesse, Germany
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Sameh Attia, DDS, MSc
UKGM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Investigator as well as the Patient are blinded.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Physician in the department of Oral and Maxillofacial Surgery,PD, Dr. med. dent., M.Sc.
Study Record Dates
First Submitted
May 6, 2024
First Posted
May 9, 2024
Study Start
December 1, 2023
Primary Completion
August 1, 2025
Study Completion
September 1, 2025
Last Updated
April 11, 2025
Record last verified: 2025-04