NCT07436091

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

February 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

May 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

February 12, 2026

Last Update Submit

April 28, 2026

Conditions

Soft Tissue Augmentation Around Dental Implants

Keywords

soft tissuedental implantssoft tissue substituesTissue thickness

Outcome Measures

Primary Outcomes (1)

  • Change in 3D Soft Tissue Thickness (mm)

    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.

    1, 3, 6, and 12 months post-surgery

Secondary Outcomes (6)

  • Patient-Reported Outcomes (PROs)

    10 days, 1, 3, 6, and 12 months

  • 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

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • 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

Study Arms (1)

Derma OsteoBiol®

EXPERIMENTAL
Procedure: Soft tissue augmentation with Derma OsteoBiol® around dental implants.

Interventions

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.

Derma OsteoBiol®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade De Medicina Dentaria da Universidade do Porto

Porto, 4200-393, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

May 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) collected during the study, including demographic characteristics, baseline clinical data, intervention details, primary and secondary outcome measures, and adverse events data. Data dictionaries describing the variables will also be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 12 months following publication of the primary results and ending 36 months after publication.
Access Criteria
Access to de-identified individual participant data will be granted to qualified researchers upon reasonable request. Requests should include a research proposal and statistical analysis plan. Data will be shared following review and approval by the study investigators and after signing a data sharing agreement.
More information

Locations

PT(1)