Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants

Dental Implants Clinical Trial

Official title:

The Clinical Effect of Simultaneous Grafting With Implant Placement Comparing Soft Tissue Grafting Alone to Combined Hard and Soft Tissue Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580811
• Other study ID #: 18.0470
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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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Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• Dental Implant &ADMG
A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .
• Dental implant & ADMG & BDX
Dental Implant will be placed with ADMG that covers the BDX

Locations

Country	Name	City	State
United States	Graduate Periodontics University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Buccal soft tissue contour around dental implant	Contour will be categorized as concave,flat or convex(subjective categories).	3 months
Secondary	Buccal soft tissue thickness around dental implants	The thickness will be measured with an endodontic file using a rubber stopper(objective measure of tissue thickness by penetrating tissue and measuring thickness in millimeters (mm).	3 months