Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion

NCT04391725 | Unknown

• 1 other identifier: Arpitha CM
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periapical Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in Quality of life from baseline to 7 days

  postoperative Day 1 to day 7

Study Arms (2)

Periapical surgery with guided tissue regeneration

EXPERIMENTAL

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 without any guided tissue regeneration

ACTIVE COMPARATOR

Patients with through and through periapical lesion will undergo periapical surgery and flap closure done.

Procedure: Periapical surgery without anyguided tissue regeneration

Interventions

Periapical surgery with guided tissue regeneration PROCEDURE

periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules

Periapical surgery with guided tissue regeneration

Periapical surgery without anyguided tissue regeneration PROCEDURE

periapical surgery will be done followed by flap closure

Periapical surgery without any guided tissue regeneration

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Sanjay Tewari

Rohtak, Haryana, 124001, India

RECRUITING

Related Publications (1)

• M A, S T, P S, A G. Efficacy of mixture of injectable-platelet-rich fibrin and type-1 collagen particles on the closure of through-and-through periapical bone defects: A randomized controlled trial. Int Endod J. 2023 Oct;56(10):1197-1211. doi: 10.1111/iej.13954. Epub 2023 Jul 17.

  PMID: 37418583 DERIVED

MeSH Terms

Interventions

Guided Tissue Regeneration

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: December 11, 2019
• Primary Completion: December 11, 2020
• Study Completion: April 11, 2021
• Last Updated: May 18, 2020

Record last verified: 2019-12

Locations

IN (1)