Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants

NCT ID: NCT03580811

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2021-04-30

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.

Detailed Description

Thirty sequentially entered patients will have a dental implant placed in maxillary sites from 4 to 13. Any implant system is acceptable since the objective of the study is to evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once selected for participation immediately prior to treatment, they are randomized for a treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft (Test Group). The graft will be placed simultaneously with the dental implant. A blinded examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will be excluded from the study. Means and standard deviations will be calculated for all parameters. A paired test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 12 will afford ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between groups. P value will be set at p≤0.05.

Conditions

Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dental Implant & ADMG

Dental implant placed with simultaneous grafting using one layer of ADMG

Group Type: ACTIVE_COMPARATOR

Dental Implant &ADMG

Intervention Type: DEVICE

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

Dental implant & ADMG & BDX

Dental implant placed plus simultaneous grafting using ADMG with BDX

Group Type: EXPERIMENTAL

Dental Implant &ADMG

Intervention Type: DEVICE

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

Dental implant & ADMG & BDX

Intervention Type: DEVICE

Dental Implant will be placed with ADMG that covers the BDX

Interventions

Dental Implant &ADMG

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

Intervention Type: DEVICE

Dental implant & ADMG & BDX

Dental Implant will be placed with ADMG that covers the BDX

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Healthy persons at least 18 years old.

3. Understands and has signed the informed consent.

Exclusion Criteria

1. Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.

2. Previous head and neck radiation.

3. Patients who have taken oral bisphosphonates for > 3 years or any IV bisphosphonates.

4. Smokers (or other tobacco habits that might interfere with soft tissue healing).

5. Patients who need prophylactic antibiotics prior to dental procedures.

6. Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.

7. Chemotherapy in the previous 12 months.

8. Psychological problems that would interfere with treatment.

9. Pregnant subjects will be excluded due to risk of miscarriage

10. Patients unable or unwilling to sign the informed consent.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Henry Greenwell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Greenwell, DMD, MSD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Graduate Periodontics University of Louisville

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

18.0470

Identifier Type: -

Identifier Source: org_study_id