Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406530
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-06
Brief Title:
Topical Application of PRF Before Radiation Therapy
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
Official Title:
Topical Application of PRF in Tooth Extraction Sockets Before Radiation Therapy for Head and Neck Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRF
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
Secondary aim is to monitore the effect on the pain perception
Detailed Description:
Head and neck cancer patients are required for a dental checkup before the beginning of the radiation therapy During this checkup the patients gets a radiological and clinical examination in order to determine any tooth or alveolar bone bound inflammatory processes Teeth associated to those conditions or those which are likely to result in any of this have to be extracted in order to prevent radiation associated complications such as osteomyelitis or further osteoradionecrosis of the jaw In order to prevent this illness it is essential to not start before the healing of the post-extraction socket has reached a sufficient state which is usually around 3 weeks post-extracitonem To facilitate the healing recent studies have shown an positive effect by applying PRF and a lower pain perception after surgical tooth removal So far it is not documented for the prevention of a osteoradionecrosis of the jaw
The patients who receive two or more tooth extractions before radiation therapy can participate in the study The preliminary diagnosis has to be a head and neck tumor which is planned to be treated with ionizing radiation equally on both sides of the jaws Both teeth have to have a similar size eg molar and molar
Patient and Doctors a blinded the site of PRF Application is chosen by random After surgical removal of the teeth one extraction socket is filled with PRF while the other is left for its natural formation of a blood clot
During the first 7 days the patient protocols the pain perception and the amount of painkillers used for both sides of the jaw After 7d 14d 21d 30d the wound healing is recorded until it reached is end in complete epithelization
3 Months after the surgery a intermediate clinical examination is performed for early signs of any complication due to the radiation therapy 6 Months after the surgery a OPG-radiograph will be taken to determine the bone healing comparing the test site and the control site
The patients who receive two or more tooth extractions before radiation therapy can participate in the study The preliminary diagnosis has to be a head and neck tumor which is planned to be treated with ionizing radiation equally on both sides of the jaws Both teeth have to have a similar size eg molar and molar
Patient and Doctors a blinded the site of PRF Application is chosen by random After surgical removal of the teeth one extraction socket is filled with PRF while the other is left for its natural formation of a blood clot
During the first 7 days the patient protocols the pain perception and the amount of painkillers used for both sides of the jaw After 7d 14d 21d 30d the wound healing is recorded until it reached is end in complete epithelization
3 Months after the surgery a intermediate clinical examination is performed for early signs of any complication due to the radiation therapy 6 Months after the surgery a OPG-radiograph will be taken to determine the bone healing comparing the test site and the control site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None