Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

Medication-related osteonecrosis of the jaw (MRONJ) is a rare but serious side-effect of antiresorptive therapies used in the management of bone diseases, such as osteoporosis or bone metastases. A surgical management can lead to a resolution of the disease, but with perfectible results. For this purpose, the use of autologous platelet concentrates (APC) can be useful. With this study, researchers aim to demonstrate the efficacy of L-PRF (Leukocyte- and Platelet-Rich Fibrin) as an adjunct to the surgical treatment of MRONJ in terms of wound healing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

MRONJ requiring surgical treatment according to AAOMS criteria (stage 2 or 3; failure of first-line treatments; sequestration of a necrotic bone block), the resection of which needs general anesthesia;

Affiliates or beneficiaries of a social security scheme.

Having given free and informed written consent.

Disqualifiers

Presence of a maxillo-mandibular neoplastic lesion;

Presence of several MRONJ lesions;

History of cervico-facial radiotherapy;

Contraindication to general anesthesia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgery with the use of L-PRF

    Procedure/Surgery

    The study protocol is the same as the standard surgery one but with additional use of L-PRF membranes

  • Standard surgery

    Procedure/Surgery

    The standard surgical treatment, taking place in the operating room under general anesthesia

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of the efficacy of the use of L-PRF during the surgical treatment of MRONJ, compared to surgical treatment alone, on complete mucosal healing.

Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the AAOMS classification.

Time frame
6 months postoperatively

Secondary outcomes

1

MRONJ stage - Month 1

Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).

Time frame
1 month postoperatively
2

MRONJ stage - Month 3

Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).

Time frame
3 months postoperatively
3

MRONJ stage - Month 6

Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).

Time frame
6 months postoperatively
4

the postoperative pain - Month 1

Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable).

Time frame
1 month postoperatively

Other outcomes

Sponsors and contacts

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