University of Giessen
Giessen, Hesse, Germany
Location status: Recruiting
NCT Number: NCT06406530
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Giessen, Hesse, Germany
Location status: Recruiting
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 jaw(s). Both teeth have to have a similar size (e.g. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Platelet rich fibrin
After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.
Other names: Blood clot formation
Time frame: around 4 Weeks
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.
Time frame: around 7 days
To compare pain perception between the two sites - the PRF test site and the control site - a visual analogue scale (VAS) for pain is provided to the patients. This scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the highest imaginable pain for the patient.
Contact information is provided by the study sponsor or research team.
Jan Nuernberg, DDS
CONTACT
(+49) 641 9946112
Sameh Attia, DDS, MSc
CONTACT
(+49) 641 9946112
University of Giessen
Other
Topical Application of PRF in Tooth Extraction Sockets Before Radiation Therapy for Head and Neck Cancer
Acronym: PRF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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