Clinical trial NCT04703738: Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants
Official title: A Prospective, Randomized and Controlled Multi-center Study of Geistlich Fibro-Gide® Compared With Connective Tissue Graft for Soft Tissue Volume Augmentation Around Dental Implants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Soft Tissue Defect
Keywords: soft tissue augmentation
soft tissue volume
Fibro-Gide
CTG
Geistlich
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
Collaborators: name: Medelis Inc.
First posted: 2021-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel, randomized, controlled, single-blind, multi-centre clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in gingival soft tissue volume assessed with 3D scanning
timeFrame: 6 months post treatment
Secondary outcomes:
measure: All Adverse Events, serious and non serious
timeFrame: Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years
measure: Post-OP Patient Reported Outcome Questionnaire
timeFrame: 6 Months, 1,3,5 Years
measure: Concomitant medication
timeFrame: 2,4,12 weeks, 6 months, 1,3,5 Years
measure: Change in gingival soft tissue contour
timeFrame: 3 months, 1,3, 5 Years
measure: General Periodontal Examination (GPE)
timeFrame: 4, 12 weeks, 6 Months, 1,3,5 Years
measure: Pink esthetic score (PES)
timeFrame: 6 Months, 1,3,5 Years
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Regenerative Solutions
state: California
city: Aurora
country: United States
facility: McClain Schallhorn Periodonitcs
state: Colorado
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
city: Virginia Beach
country: United States
facility: Periodontal and Dental Implant Surgical Specialist
state: Virginia
city: Kenosha
country: United States
facility: Santarelli Oral and Facial Surgery
state: Wisconsin
Study officials:
affiliation: Regenative Solutions
name: Donald S Clem III, DDS
role: PRINCIPAL_INVESTIGATOR
References: