Porcine Derma for Soft Tissue Augmentation Around Implants

Enrolling by invitation · Not applicable

Conditions studied: Soft Tissue Augmentation Around Dental Implants

In brief

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.

Key facts

Study ID

NCT07436091

Run by

Universidade do Porto

People needed

15

Starts

2026-04-01

Expected to finish

2027-12-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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;

Where it is running

• Faculdade De Medicina Dentaria da Universidade do Porto — Porto, Portugal

Full record on ClinicalTrials.gov

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