Gum and toothless alveolar ridge disorder not otherwise specified
Conditions
Interventions
The same flap design will be employed in both groups (n=52), and the difference will be the graft material used. Before the surgery, a random allocation sequence will be generated using randomization
Control group (CTG): autogenous connective tissue graft (n = 26)
Surgical procedure and Flap Design: For both groups, local anaesthesia will be performed, with a maximum of 4 tubes of lidocaine associated with 1:100,000 epinephrine. Control group: Two vertical rele
A10.165
E06.780.895
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: > 18 years. Presence of at least one adjacent tooth at the surgical site. Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%). Healthy. Signed Informed Consent Form.
Exclusion criteria
Exclusion criteria: Pregnant or lactating women. History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years. Smokers (>10 cigarettes/day).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the thickness of the soft tissue on the buccal side of the implant at 1 mm below the marginal gingiva, using the method of superimposing the STL files of the impressions. The preoperative STL will be considered the baseline and the difference in millimeters between the baseline and the other experimental times will be used to verify if the outcome actually occurred. We will observe whether the soft tissue volume increased between the first and subsequent STLs (intra-group evaluation) and whether there is a difference between the group that received autogenous graft and biomaterial (inter-group evaluation). These measurements will be linear and expressed in millimeters. | — |
Secondary
| Measure | Time frame |
|---|---|
| The objective is to secondarily evaluate the thickness of the soft tissue on the buccal side of the implant at 3 and 5 mm below the marginal gingiva and also, it is expected to investigate the performance of the VCMX compared to the CTG on the clinical and aesthetic criteria and the performance of the results. related to the patient compared to the CTG group.;It is expected to evaluate through clinical examination around the crown of the implant and in neighboring teeth (6 sites per implant / tooth) the marginal recession. This outcome will be measured by placing a millimeter probe at the gingival margin up to the CEJ or implant abutment interface. The value in millimeters of the measurement will be considered the outcome. It is expected that the probe measurement is zero or small, both at baseline and at subsequent experimental times and that there are no differences between groups.;Evaluate through clinical examination around the implant crown and in neighboring teeth (6 sites per implant/tooth) the depth of the probing of the region. This outcome will be verified by inserting a millimeter probe into the peri-implant sulcus/pocket. The value in millimeters of the amount of probe insertion will be considered the outcome. It is expected that probe penetration is small, both at baseline and at subsequent experimental times, and that there are no differences between groups.;It is expected to evaluate through clinical examination around the crown of the implant and in neighboring teeth (6 sites per implant / tooth) the bleeding on probing in a dichotomous way, with 0 bleeding absent and 1 bleeding present. It is expected that the score is zero, that is, no bleeding on probing, both at baseline and at subsequent experimental times, and that there are no differences between groups.;The presence or absence of plaque will be evaluated through clinical examination with the probe tip around the implant crown and on neighboring teeth (6 sites per implant/tooth also dichotomou | — |
Countries
Brazil
Contacts
Public ContactNayara de Lucena
Universidade de São Paulo
Outcome results
None listed