Soft Tissue Defect
Conditions
Keywords
soft tissue augmentation, soft tissue volume, Fibro-Gide, CTG, Geistlich
Brief summary
This double blind, randomized, parallel study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for soft tissue volume augmentation around dental implants
Detailed description
A total sample size of 60 subjects (n=60) will be evaluated at 5 centers, by 6 Investigators with approximately 10-subjects per Investigator. Power analysis based on 80% power, past Thoma, Zeltner and González-Martin studies 1,2,3 and a one-sided confidence interval of 0.025, indicates that with a volume change standard deviation between 0.5 and 0.7 mm, 17-31 subjects are required per group (test and control), so 50-60 subjects are an acceptable estimate, with a preference for 60, given potential loss to long-term follow-up.
Interventions
PROCEDURESoft tissue flap + Connective Tissue Graft
The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and graft without compression. The harvest graft donor area will be the palate in the bicuspid region on the same side as the control soft tissue augmentation therapy. The CTG will be harvested using full thickness incisions that include the periosteum and will be closed using suture and coating the incision line with a tissue adhesive. No covering stents or packs should be employed. The CTG will be sling sutured in place and the flap secured using a double sling suturing technique.
DEVICESoft tissue flap + Geistlich Fibro-Gide®
The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and matrix without compression. Geistlich Fibro-Gide® is cut to shape to the treatment site and placed dry into the site. The flap is secured using a double sling suturing technique.
Sponsors
Geistlich Pharma AG
Medelis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blind (Outcomes Examiner)
Intervention model description
parallel, randomized, controlled, single-blind, multi-centre clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects requiring soft tissue augmentation around single implants, i.e., thin biotype with potential for * All implants must be at least 6 months post bone graft/implant placement * have at least 1 mm of keratinized tissue width (KTw), * have final restoration permanently in place for at least 4-weeks and * subject have no recession on the implant body * Subjects who, can achieve good oral hygiene (80% plaque free surfaces on the implant and maintain 80% plaque free surfaces on teeth adjacent to treatment sites).
Exclusion criteria
* participation within the last six months in other interventional studies. * any systemic condition that could influence healing, such as uncontrolled diabetes mellitus - confirmed by A1C score ≥7% - cancer, HIV, oral muco- cutaneous conditions and drug induced gingival enlargement. * taking medications that compromise wound healing, such as chronic steroid use - either inhaler or systemic, calcium channel blockers with secondary hyperplastic tissue reactions, anti-seizure medications, IV bisphosphates for bone metabolic diseases, radiation or other immuno-suppressive therapy. * acute infectious lesions in the areas intended for surgery. * History within the last 6 months of weekly or more frequent use of nicotine products * Female subjects who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control * Untreated, moderate to severe periodontal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival soft tissue volume assessed with 3D scanning | 6 months post treatment | Change in gingival soft tissue volume compared to baseline \[Time Frame 6 months post-treatment\] Measured by digital contour scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Adverse Events, serious and non serious | Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years | Recording and Assessment of all (S)AEs starting from Visit 2 onwards, Surgery |
| Post-OP Patient Reported Outcome Questionnaire | 6 Months, 1,3,5 Years | subjects will answer a questionnaire regarding discomfort, esthetic satisfaction and overall satisfaction questions asked by a 3rd-party rec At Visits 2-weeks, and 1- and 3-months post-operative, subjects will answer discomfort/ pain questions asked by a 3rd-party recorder. |
| Concomitant medication | 2,4,12 weeks, 6 months, 1,3,5 Years | Concomitant medication review compared with Visit 1 and 2 |
| Change in gingival soft tissue contour | 3 months, 1,3, 5 Years | soft tissue contour measured digitally ( 3D-scan) and compared with baseline |
| General Periodontal Examination (GPE) | 4, 12 weeks, 6 Months, 1,3,5 Years | Changes of GPE at various visits compared to baseline, |
| Pink esthetic score (PES) | 6 Months, 1,3,5 Years | pink esthetic score evaluates soft tissue around single-tooth implants. The PES is based on seven variables: Mesial papilla, Distal papilla, Soft tissue Level, Soft-tissue contour, Alveolar process deficiency, Soft-tissue Color, Soft tissue texture, 2-1-0 score |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDonald S Clem III, DDS
Regenative Solutions
Outcome results
None listed