NCT03580811

Brief Summary

The study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus bovine derived xenograft is significantly increased compared to alloderm alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

June 13, 2018

Last Update Submit

June 2, 2021

Conditions

Dental Implants

Keywords

AllodermDental ImplantsAlveolar bone grafting

Outcome Measures

Primary Outcomes (1)

  • Buccal soft tissue contour around dental implant

    Contour will be categorized as concave,flat or convex(subjective categories).

    3 months

Secondary Outcomes (1)

  • Buccal soft tissue thickness around dental implants

    3 months

Study Arms (2)

Dental Implant & ADMG

ACTIVE COMPARATOR

Dental implant placed with simultaneous grafting using one layer of ADMG

Device: Dental Implant &ADMG

Dental implant & ADMG & BDX

EXPERIMENTAL

Dental implant placed plus simultaneous grafting using ADMG with BDX

Device: Dental Implant &ADMGDevice: Dental implant & ADMG & BDX

Interventions

Dental Implant &ADMGDEVICE

A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .

Dental Implant & ADMGDental implant & ADMG & BDX
Dental implant & ADMG & BDXDEVICE

Dental Implant will be placed with ADMG that covers the BDX

Dental implant & ADMG & BDX

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADMG with or without BDX.
  • Healthy persons at least 18 years old.
  • Understands and has signed the informed consent.

You may not qualify if:

  • Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
  • Previous head and neck radiation.
  • Patients who have taken oral bisphosphonates for \> 3 years or any IV bisphosphonates.
  • Smokers (or other tobacco habits that might interfere with soft tissue healing).
  • Patients who need prophylactic antibiotics prior to dental procedures.
  • Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
  • Chemotherapy in the previous 12 months.
  • Psychological problems that would interfere with treatment.
  • Pregnant subjects will be excluded due to risk of miscarriage
  • Patients unable or unwilling to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Periodontics University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Henry Greenwell, DMD, MSD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups of 15 patients . One with soft tissue grafting and implant placement and other with soft and hard tissue grafting with implant placement.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2018

First Posted

July 9, 2018

Study Start

December 4, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

June 3, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)