RecruitingPhase 2NCT06622759

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

The Use of a Porcine Collagen Matrix for the Prevention of Buccal Bone Wall During Implant Placement in the Aesthetic Zone. A Randomized Controlled Clinical Trial.


Sponsor

Aristotle University Of Thessaloniki

Enrollment

36 participants

Start Date

Mar 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • Generally healthy adult patients.
  • 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

Exclusion Criteria11

  • 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

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Interventions

PROCEDURECTG

Connective Tissue Graft has been widely used around implants to increase either the thickness of the soft tissues or the width of keratinized tissues. It is considered the gold standard for soft tissue grafting. The main drawbacks are the donor morbidity and the limit amount of intraoral donor sites. In this study it will be used in the test 1 group in order to compare its clinical results with the other groups.

PROCEDURECollagen Matrix

Collagen matrix has been used in several studies in order to evaluate its clinical properties over the last years. In this study, the graft will be placed buccally at the time of implant placement in the aesthetic zone in order to assess its clinical and radiographic properties in terms of buccal bone resorption and soft tissue augmentation. Histological assessment and Patient Reported outcomes will also be evaluated.

PROCEDUREControl group

In the control group, the implant will be placed without any kind of soft tissue graft in order to compare this treatment modality that many clinicians apply at the clinical practice.


Locations(1)

Department of Preventive Dentistry, Periodontology &amp; Implant Biology, School of Dentistry, Aristotle University

Thessaloniki, Thessaloniki, Greece

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NCT06622759


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