Bone Regenerative Techniques in Endodontic Microsurgery

Apical Periodontitis Clinical Trial

Official title:

Healing After Endodontic Microsurgery Using Resorbable Collagen Based Bone Augmentation Material: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514991
• Other study ID #: 833538
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

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