Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants

University of Louisville (UOFL)

Status: Completed

Conditions: Dental Implants

Treatments: Device: Dental Implant &ADMG; Device: Dental implant & ADMG & BDX

Study type: Interventional

Funder types: Other

Identifiers

NCT03580811

18.0470

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Dental Implant & ADMG

Active Comparator group

Description:

Dental implant placed with simultaneous grafting using one layer of ADMG

Treatment:

Device: Dental Implant &ADMG

Dental implant & ADMG & BDX

Experimental group

Description:

Dental implant placed plus simultaneous grafting using ADMG with BDX

Treatment:

Device: Dental implant & ADMG & BDX

Device: Dental Implant &ADMG