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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COMPLETED
NA
36 participants
INTERVENTIONAL
2022-01-02
2025-04-19
Brief Summary
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The primary objective of the study was to compare changes in peri-implant soft tissue thickness between the two treatment approaches over time. Secondary objectives included evaluation of aesthetic outcomes, clinical parameters, and treatment-related complications.
The study was conducted at a single academic clinical center in Poland in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements. All participants provided written informed consent prior to enrollment.
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Detailed Description
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Eligible adult patients presenting with an indication for peri-implant soft tissue augmentation in the aesthetic zone were enrolled and randomly allocated in a 1:1 ratio to one of the two intervention groups. In the CTG group, a subepithelial connective tissue graft was harvested from the palate and placed at the peri-implant site. In the VCMX group, a commercially available volume-stable collagen matrix was used for soft tissue augmentation according to the manufacturer's instructions.
Standardized surgical and prosthetic protocols were applied in both groups. Clinical examinations and outcome assessments were performed at predefined follow-up visits. The primary outcome measure was the change in peri-implant soft tissue thickness measured at the implant site over time. Secondary outcome measures included additional clinical parameters, aesthetic outcomes, patient-reported outcomes, and the incidence of adverse events or complications.
The study protocol, patient information sheet, and informed consent form were approved by the Bioethics Committee of Wroclaw Medical University prior to study initiation. The study was conducted in compliance with Good Clinical Practice guidelines, ISO 14155, and the principles of the Declaration of Helsinki. All participants provided written informed consent before any study-related procedures were performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Connective Tissue Graft (CTG)
Participants received peri-implant soft tissue augmentation using an autogenous subepithelial connective tissue graft harvested from the palate and placed at the implant site according to a standardized surgical protocol.
Connective Tissue Graft
An autogenous subepithelial connective tissue graft harvested from the palatal donor site and used for peri-implant soft tissue augmentation according to a standardized surgical protocol.
Volume-Stable Collagen Matrix (VCMX)
Participants received peri-implant soft tissue augmentation using a volume-stable collagen matrix placed at the implant site according to the manufacturer's instructions and a standardized surgical protocol.
Volume-Stable Collagen Matrix
A volume-stable collagen matrix used for peri-implant soft tissue augmentation according to the manufacturer's instructions and a standardized surgical protocol.
Interventions
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Connective Tissue Graft
An autogenous subepithelial connective tissue graft harvested from the palatal donor site and used for peri-implant soft tissue augmentation according to a standardized surgical protocol.
Volume-Stable Collagen Matrix
A volume-stable collagen matrix used for peri-implant soft tissue augmentation according to the manufacturer's instructions and a standardized surgical protocol.
Eligibility Criteria
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Inclusion Criteria
* Single-tooth edentulism in the aesthetic zone of the maxilla or mandible, bordered by natural teeth on both sides.
* Bilateral two-tooth edentulism accepted only when implants were placed in separate quadrants.
* Indication for dental implant placement with peri-implant soft tissue augmentation.
* Adequate bone volume at the implant site confirmed radiographically.
* Baseline peri-implant soft tissue thickness suitable for augmentation.
* Minimum height of keratinized tissue of at least 2 mm.
* Good oral hygiene and periodontal health.
* Ability and willingness to provide written informed consent.
Exclusion Criteria
* Severe periodontal disease or untreated oral infection.
* Bruxism or heavy smoking.
* Systemic diseases or conditions that could impair wound healing or bone metabolism.
* History of radiotherapy in the head and neck region.
* Previous or ongoing bisphosphonate therapy.
* Uncontrolled diabetes mellitus.
* Pregnancy or breastfeeding.
* Use of medications known to interfere with soft tissue healing.
18 Years
ALL
No
Sponsors
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Geistlich Pharma AG
INDUSTRY
Medical Innovation Center Wroclaw
OTHER
Responsible Party
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Jakub Hadzik
Associate Professor, PhD, DSc (Med.), Specialist in Oral Surgery
Locations
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Medyczne Centrum Innowacji Wrocław (Wrocław Medical Innovation Center), formerly operating as Akademicka Akademicka Poliklinika Stomatologiczna
Wroclaw, , Poland
Countries
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Other Identifiers
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400166
Identifier Type: -
Identifier Source: org_study_id
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