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NCT Number: NCT06406530

Topical Application of PRF Before Radiation Therapy

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.

Recruiting

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRF

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.

Other names: Platelet rich fibrin

Natural Healing

Procedure

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

Other names: Blood clot formation

Primary outcomes

  1. Wound healing between the two sites using the Wound Healing Index

    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.

Secondary outcomes

  1. PRF and Pain perception

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Nuernberg, DDS

CONTACT

[email protected]

‭(+49) 641 9946112‬

Sameh Attia, DDS, MSc

CONTACT

[email protected]

‭(+49) 641 9946112‬

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

Topical Application of PRF in Tooth Extraction Sockets Before Radiation Therapy for Head and Neck Cancer

Acronym: PRF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 9, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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