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Bone Regenerative Techniques in Endodontic Microsurgery

Primary Purpose

Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foundation
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring Persistent periapical pathology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adult.
  • Intact coronal restoration with no sign of leakage.
  • Class B (small lesion) and C (large lesion) periapical lesions. (Kim and Kratchman 2006)

Exclusion Criteria:

  • Patients with medical conditions and contraindications to surgery.
  • Minors.
  • Pregnancy.
  • Teeth with signs of coronal leakage.
  • Teeth with vertical root fractures.

Sites / Locations

  • UPenn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Surgical sites (osteotomy) assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA).

Surgical sites (osteotomy) assigned to this group receives endodontic microsurgery procedure only.

Outcomes

Primary Outcome Measures

2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
3D Radiographic Healing at 12 Months Follow up (Overall Cases)
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing.
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing

Secondary Outcome Measures

C Score (Overall Cases)
Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed).
C Score (Asymptomatic Cases Only)
Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed).

Full Information

First Posted
July 31, 2020
Last Updated
October 26, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04514991
Brief Title
Bone Regenerative Techniques in Endodontic Microsurgery
Official Title
Healing After Endodontic Microsurgery Using Resorbable Collagen Based Bone Augmentation Material: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of this randomized controlled clinical trial was to evaluate two dimensionally and 3-dimensionally the effect of resorbable collagen-based bone filling material on periapical healing following endodontic microsurgery (EMS) on endodontic lesions presenting four-wall defect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
Keywords
Persistent periapical pathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Surgical sites (osteotomy) assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Surgical sites (osteotomy) assigned to this group receives endodontic microsurgery procedure only.
Intervention Type
Device
Intervention Name(s)
Foundation
Intervention Description
Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.
Primary Outcome Measure Information:
Title
2D Radiographic Healing at 12 Months Follow up (Overall Cases)
Description
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
Time Frame
12 months
Title
3D Radiographic Healing at 12 Months Follow up (Overall Cases)
Description
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing.
Time Frame
12 months
Title
2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Description
Periapical healing was assessed by qualitatively evaluating bone regeneration through PA radiographs using well-established criteria. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing.
Time Frame
12 months
Title
3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
Description
Periapical healing was assessed by qualitatively evaluating bone regeneration through CBCT scans using Penn 3D criteria. Cases were classified into complete, limited, or unsatisfactory healing
Time Frame
12 months
Secondary Outcome Measure Information:
Title
C Score (Overall Cases)
Description
Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed).
Time Frame
12 months
Title
C Score (Asymptomatic Cases Only)
Description
Cortical plate healing using RAC/B index as evaluated on CBCT scans. Score 0: Cortical plate not re-established (Nonhealed). Score 1: Cortical plate is partially re-established (Partially healed). Score 2: Cortical plate is re-established (Completely healed).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult. Intact coronal restoration with no sign of leakage. Class B (small lesion) and C (large lesion) periapical lesions. (Kim and Kratchman 2006) Exclusion Criteria: Patients with medical conditions and contraindications to surgery. Minors. Pregnancy. Teeth with signs of coronal leakage. Teeth with vertical root fractures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bekir Karabucak, DMD, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPenn
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Bone Regenerative Techniques in Endodontic Microsurgery

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