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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAristotle University Of Thessaloniki

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Poor oral hygiene (FMPS < 20%, FMBS < 15%) and poor motivation

Heavy smokers (>10 cigarettes per day)

Need for bone augmentation

Untreated periodontitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • CTG

    Procedure/Surgery

    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.

  • Collagen Matrix

    Procedure/Surgery

    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.

  • Control group

    Procedure/Surgery

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: No GraftOther 1 intervention
Group B: CTGExperimental treatment 1 intervention
Group C: Collagen MatrixExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Soft Tissue Thickness

Thickness of soft tissue buccally

Time frame
6 months
2

Buccal Bone Thickness

Thickness of marginal bone buccally

Time frame
6 months

Secondary outcomes

1

Keratinized tissues

Width of keratinized tissues in mid-buccal aspect of implant

Time frame
6 months

Other outcomes

1

Full Mouth Bleeding Score

Full Mouth Bleeding Score: Percentage of tooth sites with bleeding when a periodontal probe is traced along the gingival margin. Range: 0-100% (the lower the percentage, the better the clinical outcome).

Time frame
6 months
2

Full mouth plaque score

Full Mouth Plaque Score: Percentage of tooth sites with detectable plaque deposits. Range: 0-100% (the lower the percentage, the better the clinical outcome).

Time frame
6 months
3

PROMs (Patient Relative Outcome Measures)

Patients will be asked to complete a questionnaire to assess the experience and subjective perception and discomfort immediatelly 10 days after the surgical procedure (during sutures removal).

Time frame
14 days (after surgical treatment)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.