Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-60
SponsorKing Abdullah University Hospital

About this trial

Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration.

However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks.

A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF).

This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Anterior or posterior mature tooth diagnosed with necrotic pulp in the presence of a periapical lesion,

Pulp space is not needed for post and core restoration.

Patients are not allergic to the medicaments necessary to complete the procedure.

Disqualifiers

Medically compromised patient.

Patient with generalized chronic periodontitis.

Teeth with previous root canal treatment.

Periodontal pocket larger than 3mm.

Trial design

Design model

Parallel

Treatments tested in this trial

  • induced bleeding

    Biological/Vaccine

    revascularization of tooth is achieved by induced bleeding

  • plasma rich fibrin

    Biological/Vaccine

    revascularization of tooth is achieved by plasma rich fibrin

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Induced bleeding groupActive comparator 1 intervention
Group B: Platelet-rich fibrin (PRF) groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete healing

Assess clinically and radiographically absence of symptoms and signs And evidence for continuation of root development after regeneration procedures

Time frame
treated teeth will be evaluated from start of intervention up to 100 months

Secondary outcomes

1

regain the pulp sensibility

asses pulp sensibility using cold test

Time frame
pulp sensibility will be evaluated one year after treatment

Other outcomes

Sponsors and contacts

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King Abdullah University Hospital

Lead sponsor

Jordan University of Science and Technology

Collaborator