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UnknownNCT04396743

Comparative Evaluation of Two PRF Formulations on Quality of Life and Healing of Apicomarginal Defects

Comparative Evaluation of Two PRF Formulations on Quality of Life and 2D and 3D Assessment of Healing Outcome of Apicomarginal Defects.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
Sex
All
Age
16 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Healing of apicomarginal defects using 2 different formulations of PRF i.e PRF -high and PRF-medium will be assessed and compared using 2D and 3D criteria. Also, in vitro evaluation of the PRF formulations and quality of life will be compared between the two groups.

Detailed description

Periapical surgery is a viable treatment option in teeth with persistent apical periodontitis, especially in cases which fail to heal by non surgical treatment. Kim and Kratchman classified periradicular lesions into categories A-F. Lesions A-C are of endodontic origin without any periodontal pockets and vary with respect to the size of periapical radiolucency while D-F are combined endodontic - periodontal origin and are ranked accoding to the magnitude of periodontal breakdown. Type F defects are commonly referred to as apicomarginal defects and have worst prognosis among all. The lower success rate is attributed to the apical migration of junctional epithelium and intrusion of non osteogenic connective tissue into the periapical region. Recently, autologous platelet concentrates have been used instead of the conventional practice of using GTR barrier membranes for treating apicomarginal defects. Till date no human study has compared platelet formulations; PRF-high ( 2700 rpm for 12minutes) and PRF-medium (1500 rpm for 14minutes) to see any difference in the bony healing and the quality of life between the two groups and no study have assessed bony healing of the periapical defect with periodontal communication with the use of CBCT. Thus, the aim of the present study is to investigate the effect of 2 different formulations of PRF on quality of life and healing outcome of periapical defects with periodontal communications . Also, in vitro histological and immunohistochemical evaluation and comparison of the clots prepared from different centrifugation protocols will be done .

Conditions

Interventions

TypeNameDescription
PROCEDUREPeriapical surgery with use of prf-high clot and membranePeriapical surgery will be done followed by placement of prf-high clot into the defect and membrane over the defect before closure of the flap.
PROCEDUREPeriapical surgery with use of prf-medium clot and membranePeriapical surgery will be done followed by placement of prf-medium clot in the defect and membrane over the defect before closure of the flap.

Timeline

Start date
2019-12-11
Primary completion
2021-04-11
Completion
2021-04-11
First posted
2020-05-21
Last updated
2020-05-21

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT04396743. Inclusion in this directory is not an endorsement.