Bone Regenerative Techniques in Endodontic Microsurgery

Not Applicable

Completed

• Conditions: Apical Periodontitis
• Interventions: Device: Foundation

• Registration Number: NCT04514991
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-17
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Results First Submitted: 2022-07-25
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Results First Posted: 2022-11-21
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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)

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
2D Radiographic Healing at 12 Months Follow up (Overall Cases)	12 months	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)	12 months	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
3D Radiographic Healing at 12 Months Follow up (Overall Cases)	12 months	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)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
C Score (Asymptomatic Cases Only)	12 months	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 (Overall Cases)	12 months	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).

Trial Locations

Locations (1)

UPenn; 🇺🇸 Philadelphia, Pennsylvania, United States