Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion

Healing Following Use Of Injectable Platelet Rich Fibrin With Collagen During Surgery In Through And Through Periapical Lesions

Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery

Study Overview

• Status: Unknown
• Conditions: Periapical Lesion
• Intervention / Treatment: Procedure: Periapical surgery with guided tissue regeneration; Procedure: Periapical surgery without anyguided tissue regeneration

Detailed Description

Detailed patient examination will be carried out and those satisfying inclusion criteria will be enrolled in the study. Written informed consent will be obtained and patients will be randomly allocated to two groups. Entire surgical procedure will be carried out by single operator. After complete elevation of the flap, debridement (periradicular curettage -enucleation) of the bony lesion will be performed. 3 mm root-tip resection will be performed and root end cavity will be prepared using an ultrasonic diamond-coated retrotip. Root end filling will be done with mineral trioxide aggregate (MTA). In test group The i-PRF will be produced and incorporated with collagen will be used to fill into the defect. In the control group, no guided tissue regeneration technique will be used. Flap will be re-positioned and sutured using nonabsorbable 4-0 silk sutures.Sutures will be removed 4-7 days postoperatively.

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

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Sanjay Tewari
      • Contact: Sanjay Tewari, MDS; Phone Number: 9416259534; Email: principalpgids@yahoo.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 53 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of age 16-55 years with a clinical & radiographic diagnosis of through and through periradicular lesion using CBCT
• Negative response to sensitivity tests with radiographic evidence of periapical radiolucency.
• Failed previous root canal treatment primary or secondary with purulent discharge and radiographic evidence of periapical pathology.
• The teeth must have adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria:

• Unrestorable tooth.
• Fractured / perforated tooth.
• Systemic diseases contraindicating surgical procedures or with potential to affect healing.
• Teeth with deep pockets.
• Patient requiring antibiotic premedication.
• Patients with history of antibiotic use in last 3 months.
• Smokers

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
Experimental: Periapical surgery with guided tissue regeneration; Patients with through and through periapical lesion will undergo periapical surgery and the defect is filled with mixture of iPRF and type 1 collagen granules before flap closure.	Procedure: Periapical surgery with guided tissue regeneration; periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules
Active Comparator: Periapical surgery without any guided tissue regeneration; Patients with through and through periapical lesion will undergo periapical surgery and flap closure done.	Procedure: Periapical surgery without anyguided tissue regeneration; periapical surgery will be done followed by flap closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in periapical radiolucency at 12 months	2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 month with following scoring scores for 2D healing Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure) scores for 3D healing Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing	baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Quality of life from baseline to 7 days	caliberated operator will score the quality of life questionnaire in patients following surgical endodontic treatment	postoperative Day 1 to day 7

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): December 11, 2020
• Study Completion (Anticipated): April 11, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Arpitha CM

Drug and device information, study documents

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