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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04514991
Other study ID # 833538
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2019
Est. completion date March 30, 2022

Study information

Verified date October 2022
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date March 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
Foundation
Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.

Locations

Country Name City State
United States UPenn Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
Primary 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. 12 months
Primary 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. 12 months
Primary 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 12 months
Secondary 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).
12 months
Secondary 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).
12 months
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