Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioHorizons, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).
Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective Tissue Graft - Control | Active Comparator | The donor tissue was harvested from tissue palatal to maxillary premolars and anterior to the mesial of the first molars. A horizontal incision corresponding to the width of the recipient bed plus 4mm was made 3 mm apical to the gingival margin. A small secondary vertical incision was tolerated on the mesial aspect of the surgical site to allow for a split thickness technique. The flap was then positioned over the graft and sutured with attempts to cover the grafted tissue to 2mm coronal to the implant/abutment interface pending flap tension. Follow up was monitored over 6 months at various time-points. |
|
| Alloderm - Test | Experimental | ADM graft was prepared according to the manufacturer's instructions. The preparation requires rehydration in 50ml sterile saline or Ringers Solution for five minutes and repeated twice. The graft was then transferred to the recipient bed with the basement membrane side facing up and connective tissue on the periosteum. The allograft was trimmed to cover the defect dimensions up to the implant-abutment interface. There was a 4mm margin added to the width on each side to account for lateral contraction as with the connective tissue. With sterile moist gauze, pressure was applied to the graft for proper adaptation to the wound bed. The graft was sutured with a single sling and the flap with a double sling. Simple interrupted sutures were used to close vertical releases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft Tissue Grafting | Procedure | All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared. Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement. |
| Measure | Description | Time Frame |
|---|---|---|
| Recession Correction | Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Concavity Correction | At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Thickness | Tissue thickness was measured with a 25 endodontic file with rubber stopper at baseline, 6 weeks, 3 months and 6 months after grafting. | 6 Months |
| Implant Esthetics | Implant esthetics were rated with written survey by both the subject and clinician. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hom-Lay Wang, DDS, MS, PhD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 6 Months |
| Psychosocial Data | Subjects completed questionnaires regarding their quality of life during the study by written survey. | 6 months |