Porcine Derma for Soft Tissue Augmentation Around Implants

Description of the study methodology (including the expected completion date) This is a prospective, controlled, post-marketing clinical follow-up study (Phase IV), to be conducted at the Faculty of Dental Medicine of the University of Porto. The aim is to evaluate the effectiveness of the resorbable porcine-derived collagen matrix Derma OsteoBiol® for soft tissue augmentation around dental implants.

Fifteen adult participants, aged 18 years or older, will be included, presenting a need for augmentation of the keratinized mucosa at the buccal aspect of an implant previously placed in the posterior region of the maxilla or mandible. Participants must be able to understand the nature of the study, provide free and informed consent, comply with the procedures and visits defined in the protocol, and maintain good oral hygiene. The dental implant must have been placed at least six weeks prior to the start of the study, and the width of the buccal keratinized mucosa must be great than one millimeters.

Individuals with general contraindications to dental surgery, such as uncontrolled use of anticoagulants, or presenting vertical bone defects greater than three millimeters at the implant site, will be excluded. Additional exclusion criteria include: heavy smoking (more than ten cigarettes per day), presence of active periodontal or peri-implant disease, insulin-dependent diabetes mellitus, history of malignant neoplasia with treatment within the last five years, pregnancy or breastfeeding, lack of effective contraception in women of childbearing age, use of medications that affect soft tissue healing, systemic diseases interfering with connective tissue metabolism (such as autoimmune or arterial diseases), alcohol abuse, collagen allergy, participation in other clinical studies within the previous six months, inadequate oral hygiene (plaque index greater than 25%), or occurrence of any adverse event preventing continuation of treatment.

After inclusion, participants will undergo mucogingival surgery using the VISTA (Vestibular Incision Submucosal Tunnel Access) surgical technique. The Derma OsteoBiol® membrane will be pre-hydrated in sterile saline solution, trimmed, and positioned at the surgical site, and stabilized with monofilament sutures. The incision will be completely closed, avoiding membrane exposure.

Tissue thickness will be assessed through intraoral digital impressions and three-dimensional tissue volume analysis, with measurements performed before surgery and at 1, 3, 6, and 12 months after the intervention. These images will be superimposed using stable anatomical reference points to ensure accuracy and will be analyzed by a calibrated and independent examiner. Clinical data will also be collected throughout the study, including measurements of keratinized mucosa width, probing depth, clinical attachment level, presence of bleeding on probing, plaque index, and gingival recession. Standardized clinical photographs will be obtained at each visit for documentation of soft tissue status and aesthetic evaluation.

Patient perspective will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14) and a numerical pain rating scale, applied at specific follow-up time points. The occurrence of adverse events will be continuously monitored and recorded in accordance with applicable legal and regulatory standards.

This study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice.

• Soft tissue augmentation with Derma OsteoBiol® around dental implants. (Procedure): 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.

Primary outcomes

• 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.

Secondary outcomes

• Patient-Reported Outcomes (PROs) [10 days, 1, 3, 6, and 12 months]: Oral Health Impact Profile-14 (OHIP-14): Administered at baseline (Visit 2), and at 10 days, and at 1, 3, 6, and 12 months postoperatively.
• General Clinical Measurements [screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months]: Clinical parameters will include keratinized tissue (KT) width, probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and recession depth. These will be evaluated at screening, baseline, and during follow-up visits
• Safety Monitoring [baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months]: Patients will be continuously monitored for adverse events. Any device-related complaints or failures will be promptly reported to the manufacturer in accordance with regulatory requirements.
• Aesthetic Outcomes [screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months]: Aesthetic evaluation will include the Papilla Index (Jemt, 1997), spectrophotometric comparison of mucosal color to the contralateral site, and the Pink Esthetic Score (PES) as proposed by Fürhauser et al. (2005).
• Clinical Photographs [screening (-30 to -1), baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months]: Soft tissue conditions will be documented through standardized clinical photography taken at baseline, during surgery, and at follow-up visits.
• Pain Assessment (NRS) [10 days, 1 month, and any time the patient reports increased discomfort (through study completion, an average of 1 year).]: Pain Assessment (NRS) with the pain with the numerical rating scale. Will be employed at 10 days, 1 month, and any time the patient reports increased discomfort.

Other outcomes

• Surgical Complications [baseline (day 0), Visit 3 - 10 days, Visit 4 - 1 month, Visit 5 - 3 months, Visit 6 - 6 months, Visit 7 - 12 months]: Any complications affecting implant survival or requiring clinical intervention will be documented using an adverse event form. Details regarding the nature of the event, clinical management, and outcomes will be recorded.

Sex: All, ages: 18 Years to any

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;