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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Regenerative Solutions
Fullerton, California, United States
McClain Schallhorn Periodonitcs
Aurora, Colorado, United States
Perio Health Professionals
Houston, Texas, United States
Periodontal and Dental Implant Surgical Specialist
Virginia Beach, Virginia, United States
Change in gingival soft tissue volume assessed with 3D scanning
Change in gingival soft tissue volume compared to baseline \[Time Frame 6 months post-treatment\] Measured by digital contour scan
Time frame: 6 months post treatment
All Adverse Events, serious and non serious
Recording and Assessment of all (S)AEs starting from Visit 2 onwards, Surgery
Time frame: Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years
Post-OP Patient Reported Outcome Questionnaire
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.
Time frame: 6 Months, 1,3,5 Years
Concomitant medication
Concomitant medication review compared with Visit 1 and 2
Time frame: 2,4,12 weeks, 6 months, 1,3,5 Years
Change in gingival soft tissue contour
soft tissue contour measured digitally ( 3D-scan) and compared with baseline
Time frame: 3 months, 1,3, 5 Years
General Periodontal Examination (GPE)
Changes of GPE at various visits compared to baseline,
Time frame: 4, 12 weeks, 6 Months, 1,3,5 Years
Pink esthetic score (PES)
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
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Santarelli Oral and Facial Surgery
Kenosha, Wisconsin, United States
Time frame: 6 Months, 1,3,5 Years