TO DETERMINE THE EFFECT OF ALLOGRAFT AND iPRF WITH OR WITHOUT COLLAGEN MEMBRANE ON HEALING OF APICOMARGINAL DEFECTS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

To determine the effect of allograft and iPRF with or without collagen membrane on healing of apicomarginal defects : A Randomized Controlled Trial

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's).

Patients aged 18 years and above, presenting with chronic suppurative apical periodontitis in at least one tooth,

Radiographic evidence of apical radiolucency with periodontal pocket depth exceeding 6 mm confined to buccal aspect of the root.

Repeated abscess discharge despite satisfactory root canal treatment. 5.Patients with apicomarginal defects showing a denuded buccal bone plate

Disqualifiers

Clinical or radiographic evidence of root fracture.

Resorptive processes involving more than apical third of the root.

Chronic generalized periodontitis.

Failed previous endodontic surgery or failed root canal re-treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endodontic Micro-Surgery

    Procedure/Surgery

    Surgery performed using bone graft(DFDBA) and iPRF with collagen membrane in test group and bone graft and iPRF without collagen membrane in control group

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: patients with apicomarginal defects receiving bone graft and iPRF with collagen membraneExperimental treatment 1 intervention
Group B: patients with apicomarginal defects receiving bone graft and iPRF without collagen membraneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Periapical healing assessment

Periapical healing comparison in 2 groups with buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). \& modified PENN 3D criteria .

Time frame
Base line to 12 months

Secondary outcomes

1

Quality of life assessment

to assess pain, swelling, mouth opening and effect on daily activities of patient among test and control group using OHIP-14 questionnaire. Pain Assesment with Value 0 indicate no pain \& 100 indicate maximum pain.

Time frame
Base line to 12 months

Other outcomes

Sponsors and contacts

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