Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants
NCT ID: NCT04703738
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2018-08-13
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Soft tissue flap + Connective Tissue Graft
Soft 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.
Test
Soft tissue flap + Geistlich Fibro-Gide®
Soft 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.
Interventions
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Soft 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.
Soft 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Medelis Inc.
INDUSTRY
Geistlich Pharma AG
INDUSTRY
Responsible Party
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Principal Investigators
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Donald S Clem III, DDS
Role: PRINCIPAL_INVESTIGATOR
Regenative Solutions
Locations
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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
Countries
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Other Identifiers
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10808-122
Identifier Type: -
Identifier Source: org_study_id