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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
CTG
Procedure/SurgeryConnective 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/SurgeryCollagen 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/SurgeryIn 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
Trial outcomes
Primary outcomes
Soft Tissue Thickness
Thickness of soft tissue buccally
Buccal Bone Thickness
Thickness of marginal bone buccally
Secondary outcomes
Keratinized tissues
Width of keratinized tissues in mid-buccal aspect of implant
Other outcomes
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).
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).
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).
Sponsors and contacts
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