NCT05802602

Brief Summary

The purpose of this study is to compare porcine collagen membrane and bovine collagen wound dressing in human tooth extraction sites. The outcomes measured will be soft tissue thickness changes as well as bone density changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

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

First Submitted

Initial submission to the registry

March 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

April 16, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 11, 2026

Status Verified

May 1, 2025

Enrollment Period

2.6 years

First QC Date

March 2, 2023

Last Update Submit

February 6, 2026

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

  • Soft Tissue Thickness in mm

    Soft tissue biopsy to determine tissue thickness, measured in mm

    6 weeks

Secondary Outcomes (2)

  • Bone Density Measurements

    Baseline, 3 Months

  • Interleukin-1beta

    Baseline, 2 Weeks & 6 Weeks

Study Arms (2)

Porcine Collagen Membrane

EXPERIMENTAL

Atraumatic tooth extraction with porcine collagen membrane placement

Device: Porcine Collagen Membrane

Bovine Collagen Dressing

ACTIVE COMPARATOR

Atraumatic tooth extraction with bovine collagen dressing placement

Device: Bovine Collagen Dressing

Interventions

Porcine Collagen MembraneDEVICE

Atraumatic tooth extraction with porcine collagen membrane placement

Also known as: Mucograft
Porcine Collagen Membrane
Bovine Collagen DressingDEVICE

Atraumatic tooth extraction with bovine collagen dressing placement

Also known as: Heliplug
Bovine Collagen Dressing

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking
  • Aged 19-65
  • Requiring premolar or anterior tooth extraction and graft procedures
  • Good general health
  • Willing to provide informed consent.

You may not qualify if:

  • History of radiation therapy or bisphosphonate use
  • Pregnancy or breastfeeding
  • Systemic conditions that affect bone healing
  • Contraindications to dental implants
  • Inability to attend follow-up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, 68503, United States

Location

Study Officials

  • Amy C Killeen, DDS, MS

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2023

First Posted

April 6, 2023

Study Start

April 16, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

February 11, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)