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.

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.

Study Overview

• Status: Unknown
• Conditions: Apico Marginal Defects
• Intervention / Treatment: Procedure: Periapical surgery with use of prf-high clot and membrane; Procedure: Periapical surgery with use of prf-medium clot and membrane

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Sanjay Tewari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Periapical surgery with placement of prf high clots; Patients will undergo periapical surgery and PRF-high clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap.	Procedure: Periapical surgery with use of prf-high clot and membrane; Periapical surgery will be done followed by placement of prf-high clot into the defect and membrane over the defect before closure of the flap.
Active Comparator: Periapical surgery with placement of prf medium clots; Patients will undergo periapical surgery and PRF-medium clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap.	Procedure: Periapical surgery with use of prf-medium clot and membrane; Periapical surgery will be done followed by placement of prf-medium clot in the defect and membrane over the defect before closure of the flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing of apicomarginal defects.	Patients will be checked clinically for absence of signs and symptoms. Radiographic 2D assessment will be done by Rud and Molven criteria as follows:-; Complete healing- defined by re-establishment of the lamina dura; Incomplete healing (scar tissue); Uncertain healing; Unsatisfactory healing (failure). 3D healing will be assessed by modified PENN 3D criteria(Schloss et al) as-; Complete healing; Limited healing; Uncertain healing; Unsatisfactory healing.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of quality of life.	All patients will be given a questionnaire (Igor Tsesis et al) with 15 questions to evaluate their quality of life for 7 days postsurgery.	Baseline to day 7 postoperatively

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Anticipated): April 11, 2021
• Study Completion (Anticipated): April 11, 2021

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: vidhiendo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No