Soft tissue augmentation with Derma OsteoBiol® around dental implants.
Soft tissue augmentation with Derma OsteoBiol® around dental implants.: OsteoBiol® Derma collagen membranes will be hydrated in saline before surgery. Using the VISTA technique, a vertical incision apical to the site will be made under local anesthesia, avoiding papillae. A full-thickness flap will be elevated with tunneling instruments. The membrane will be trimmed to fit, placed laterally, and secured with 6/0 monofilament vertical mattress sutures. The incision will be closed with the same suture.
Study summary
Brief description of the study objectives The present study aims to evaluate the effectiveness of the porcine-derived collagen matrix Derma OsteoBiol® for peri-implant soft tissue augmentation.
The objectives include:
Measuring changes in soft tissue thickness (in 3D) in the buccal region of the treated implants; Analyzing patient-reported outcomes (PROMs), namely pain and impact on oral health-related quality of life; Monitoring the stability of peri-implant tissues and aesthetic parameters over a 12-month period.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* • Patients must have the ability to fully understand the nature of the proposed surgery, voluntarily consent to participate and signed the Informed Consent Form before any study related procedures are performed.
* Agree with data collection and analyses.
* Males or females who are a minimum of 18 years of age or older.
* Ability to comply with study-related procedures, including maintaining good oral hygiene and attending follow-up appointments.
* Implant placement at least 6 weeks prior to enrolment.
* There must be a need for soft tissue augmentation in an implant side.
* Implant located in the posterior areas of the maxilla or mandibula (molar or 2nd premolars).
* Basic periodontal examination (BPE) score must be less than 2.
* patients exhibiting KT width of \>2 mm at the buccal aspect of the implant.
Exclusion Criteria:
* • Patients who meet any of the following exclusion criteria are not eligible for inclusion in the study.
* General contraindications for dental and/or surgical treatment, including the use of anticoagulants.
* Presence of a vertical bone dehiscence greater than 3 mm at the implant site, as assessed at the time of soft tissue augmentation surgery.
* Heavy smoking habit, defined as consuming more than 10 cigarettes per day.
* Presence of active periodontal or peri-implant disease.
* Insulin-dependent diabetes.
* History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years.
* Women of childbearing age who are not using a highly effective method of contraception.
* Pregnancy or breastfeeding.
* Previous or current use of medication that affects mucosal healing in general, such as steroids or large doses of anti-inflammatory drugs.
* Any disease or condition affecting connective tissue metabolism, such as arterial diseases in the operating area, bone metabolic disorders, or alcohol abuse.
* Systemic diseases such as diabetes or autoimmune diseases.
* Allergy to collagen.
* Participation in an investigational device or drug clinical trial within the last 6 months.
* Inadequate oral hygiene (FMPS\>25%)
* An adverse event occurred, whether or not study device related, which precluded continued treatment;
Primary outcome measure(s)
Change in 3D Soft Tissue Thickness (mm) — 1, 3, 6, and 12 months post-surgery Digital impressions will be superimposed to assess changes in 3D soft tissue thickness at the buccal aspect of treated implant sites. Measurements will be performed by an independent, calibrated examiner at baseline and at 1, 3, 6, and 12 months post-surgery, following standardized 3D model analysis protocols.
Trial sites (1)
Facility
City
Region
Status
Faculdade De Medicina Dentaria da Universidade do Porto
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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