Topical Application of PRF Before Radiation Therapy

ConditionPRF

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-99

SponsorUniversity of Giessen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Head and neck cancer with planed radiation therapy

Bilateral tooth extraction

Similar tooth size

Atraumatic tooth extractions without flap surgery

Disqualifiers

Prior radiation therapy in the head and neck area

Prior and current therapy with bisphosphonates or equivalent modern biologics

Patients during pregnancy or breastfeeding

Trial design

Design model

Single group

Treatments tested in this trial

PRF
Procedure/Surgery
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.
Natural Healing
Procedure/Surgery
After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.

Treatment groups

34 Participants

are divided into 2 treatment groups

Group A: PRF site (test site)Experimental treatment 1 intervention

Group B: Blood clot (control site)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Wound healing between the two sites using the Wound Healing Index

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 4 Weeks

Secondary outcomes

PRF and Pain perception

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.

Time frame

around 7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Giessen

Lead sponsor

Source ClinicalTrials.gov

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