Endodontic Microsurgery

ConditionApical Periodontitis

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-90

SponsorMark Schachman

About this trial

Current literature on platelet rich fibrin (PRF) use in apicoectomies, also known as endodontic microsurgery, is sparse. PRF use in oral surgery or periodontal surgery has been more thoroughly researched. Whether it is able to reduce post-op pain or if it improves success rate in endodontic microsurgery is not well known. It is also not well known if it will be able to increase the rate of healing. This study will evaluate the success of endodontic microsurgery with and without PRF.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Maxillary or Mandibular Anterior teeth and premolars #4-13 and #20-29 with a history of failing RCT and a periapical radiolucency will be accepted

Disqualifiers

Patients with vertical root fractures

Patients with non-restorable teeth

Patients with class 3 mobility

Pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

Platelet rich fibrin
Biological/Vaccine
Platelet rich fibrin will be used to fill an osteotomy after endodontic microsurgery is completed.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Microsurgery with Platelet Rich FibrinExperimental treatment 1 intervention

Group B: Microsurgery AloneNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in bone deposition using voxel-based imposition

From the CBCT images Invivo imaging software (Anatomage, San Jose, CA, USA) will be used to obtain measurements from voxel-based superimposition. The voxel-based imposition is automated by the software to match the voxel grayscale values from the two image volumes. Originally developed by Bazina et al. this analysis method has been demonstrated to show reliable and accurate data. The Linear measurements will be obtained on the cross-section view (sagittal, coronal, and axial) of the periapical lesion on CBCT-1 (6 months) and CBCT-2 (12 months) images.

Time frame

6 months, 12 months, and 18 months

Secondary outcomes

Healing outcome assessed using clinical and radiographic findings

Healing will be assessed by two, board-certified endodontists and a board-certified maxillofacial radiologist. If a consensus cannot be reached, an additional board-certified endodontist will assist in the determination. Healing assessment assisted with 2D imaging will be classified according to Friedmann. These will include healed, healing, or persistent disease. Each will be given a grade of 1-3, one being healed and 3 being persistent disease.

Time frame

6 months, 12 months, and 18 months

Sponsors and contacts

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

Mark Schachman

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: