Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants
- Conditions
- Soft Tissue Defect
- Registration Number
- NCT04703738
- Lead Sponsor
- Geistlich Pharma AG
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (5)
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
Santarelli Oral and Facial Surgery
🇺🇸Kenosha, Wisconsin, United States
Regenerative Solutions🇺🇸Fullerton, California, United States