Recruiting PHASE2 Soft Tissue Augmentation

Prevention study for Soft Tissue Augmentation

Official title The Use of a Porcine Collagen Matrix for the Prevention of Buccal Bone Wall Resorption During Implant Placement in the Aesthetic Zone.

ClinicalTrials.gov ID: NCT06622759

What this study is testing

What it's testing
Aim: To provide a comparative assessment of the clinical and radiographic effect of porcine collagen matrix when placed buccally at the time of single implant placement in the aesthetic zone vs autogenous connective tissue graft in terms of buccal bone resorption and soft tissue augmentation 6 months post operative. Histological assessment and patient reported outcomes were reported
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75. Healthy volunteers may be eligible.

You may be able to join if

  • Generally healthy adult patients.
  • 18 years or older.
  • Need for replacement of single implant in the upper aesthetic zone (second premolar to second premolar)
  • Ridge width (bucco-lingual) no greater than 6 mm at its narrowest point.
  • Minimum 2mm of attached gingiva.

You likely can't join if

  • Poor oral hygiene (FMPS \< 20%, FMBS \< 15%) and poor motivation
  • Heavy smokers (\>10 cigarettes per day)
  • Need for bone augmentation
  • Untreated periodontitis
  • General contraindications for dental and/or surgical treatment
  • History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years
See the full eligibility criteria
Who can join
  • Generally healthy adult patients.
  • 18 years or older.
  • Need for replacement of single implant in the upper aesthetic zone (second premolar to second premolar)
  • Ridge width (bucco-lingual) no greater than 6 mm at its narrowest point.
  • Minimum 2mm of attached gingiva.
  • Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations.
  • Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
What rules you out
  • Poor oral hygiene (FMPS \< 20%, FMBS \< 15%) and poor motivation
  • Heavy smokers (\>10 cigarettes per day)
  • Need for bone augmentation
  • Untreated periodontitis
  • General contraindications for dental and/or surgical treatment
  • History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years
  • Women of child bearing age, not using a standard accepted method for contraception
  • Pregnancy or breast feeding
  • Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs
  • Disease affecting connective tissue metabolism (e.g. collagenases)
  • Allergy to collagen

The study team makes the final eligibility decision.

Where it's taking place

  • Thessaloniki, Thessaloniki, Greece

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Thessaloniki, Thessaloniki, Greece. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.