Edentulous Alveolar Ridge Atrophy, Soft Tissue Augmentation At Dental Implants
Conditions
Brief summary
Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance. The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.
Interventions
Sponsors
University of Florence
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Examiners will be blinded throughout all experimental procedures for all measurements. Operators will be blinded until they will raise the flap and screw the healing abutment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * No systemic diseases or pregnancy. * Self-reported smoking ≤10 cigarettes/day. * No probing depths ≥5 mm * Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤15% (measured at four sites per tooth). * Single dental implant with a scheduled for soft tissue augmentation procedure at the time of uncovering. * Need of soft tissue augmentation for aesthetic purpose and/or functional reasons * No previous soft tissue augmentation procedure at experimental site.
Exclusion criteria
* General contraindications for dental and/or surgical treatments * Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy * Inflammatory and autoimmune disease of oral cavity * History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years * Radiotherapy of head area * Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants) * Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease) * Untreated acute periodontal disease * Patients who smoke more than 10 cigarettes/day will be excluded from the study * Diabetes * Allergy to the collagen * Pregnant or lactating women * Women of child bearing age, not using a highly effective method of birth control * Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GT | Immediately After Surgery | Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMs | Immediately After Surgery | After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)) |
| KT | At Baseline | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe |
Countries
Italy
Outcome results
None listed