Clinical trial NCT04396743: Comparative Evaluation of Two PRF Formulations on Quality of Life and Healing of Apicomarginal Defects
Official title: Comparative Evaluation of Two PRF Formulations on Quality of Life and 2D and 3D Assessment of Healing Outcome of Apicomarginal Defects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apico Marginal Defects
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 .

Eligibility criteria: Inclusion Criteria:

1. Patients of age 16 years and above.
2. 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.
3. periapical defect with periodontal communication.
4. Periodontal pocket \>6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
5. Negative response to vitality test.
6. failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.

Exclusion Criteria:

1. Presence of buccal bone on flap elevation.
2. Unrestorable tooth.
3. fractured /perforated roots.
4. smokers.
5. pregnant females and lactating mothers

Primary outcomes:
measure: Healing of apicomarginal defects.
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Assessment of quality of life.
timeFrame: Baseline to day 7 postoperatively
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Sanjay Tewari
state: Haryana
Study officials:
References: