Topical Application of PRF Before Radiation Therapy

Trial Title: Topical Application of PRF Before Radiation Therapy

NCT ID: NCT06406530

Condition: PRF

Conditions: Keywords:
PRF
wound healing
dentistry
oral surgery
radiation therapy
cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Intervention model description: RCT

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Masking description: Investigator as well as the Patient are blinded.

Intervention:

Intervention type: Procedure
Intervention name: PRF
Description: 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.
Arm group label: PRF site (test site)

Other name: Platelet rich fibrin

Intervention type: Procedure
Intervention name: Natural Healing
Description: After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.
Arm group label: Blood clot (control site)

Other name: Blood clot formation

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.

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 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - Prior radiation therapy in the head and neck area - Prior and current therapy with bisphosphonates or equivalent modern biologics - Patients during pregnancy or breastfeeding

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Giessen

Address:
City: Gießen
Country: Germany

Status: Recruiting

Contact:
Last name: Sameh Attia, MSc

Phone: +49 176 80732647
Email: Sameh.Attia@dentist.med.uni-gie

Start date: December 1, 2023

Completion date: April 1, 2025

Lead sponsor:
Agency: University of Giessen
Agency class: Other

Source: University of Giessen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06406530