Topical Application of PRF Before Radiation Therapy

NCT ID: NCT06406530

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-09-01

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.

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.

Conditions

PRF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRF site (test site)

The 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.

Group Type: EXPERIMENTAL

PRF

Intervention Type: PROCEDURE

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.

Blood clot (control site)

The 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.

Group Type: ACTIVE_COMPARATOR

Natural Healing

Intervention Type: PROCEDURE

After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.

Interventions

PRF

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.

Intervention Type: PROCEDURE

Natural Healing

After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.

Intervention Type: PROCEDURE

Other Intervention Names

Platelet rich fibrin; Blood clot formation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Giessen

OTHER

Sponsor Role: lead

Responsible Party

Sameh Attia

Senior Physician in the department of Oral and Maxillofacial Surgery,PD, Dr. med. dent., M.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Attia, DDS, MSc

Role: STUDY_DIRECTOR

UKGM

Locations

University of Giessen

Giessen, Hesse, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sameh Attia, DDS, MSc

Role: CONTACT

Sameh.Attia@dentist.med.uni-giessen.de

‭(+49) 641 9946112‬

Jan Nuernberg, DDS

Role: CONTACT

jan.nuernberg@uk-gm.de

‭(+49) 641 9946112‬

Facility Contacts

Sameh Attia, MSc

Role: primary

Sameh.Attia@dentist.med.uni-gie

+49 176 80732647

Other Identifiers

TAPRFPR

Identifier Type: -

Identifier Source: org_study_id