NCT04514991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 21, 2022

Completed
Last Updated

November 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2.6 years

First QC Date

July 31, 2020

Results QC Date

July 25, 2022

Last Update Submit

October 26, 2022

Conditions

Apical Periodontitis

Keywords

Persistent periapical pathology

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • C Score (Overall Cases)

    12 months

  • C Score (Asymptomatic Cases Only)

    12 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: Foundation

Control

NO INTERVENTION

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

Interventions

FoundationDEVICE

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

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPenn

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Results Point of Contact

Title
Dr. Bekir Karabucak
Organization
University of Pennsylvania- Endodontic Department
bekirk@upenn.edu
2158984927

Study Officials

  • Bekir Karabucak, DMD, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 17, 2020

Study Start

September 3, 2019

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

November 21, 2022

Results First Posted

November 21, 2022

Record last verified: 2022-10

Locations

US(1)