Tooth Loss
Conditions
Interventions
- Number of study participants:
Control Group - 32 Participants.
Test Group - 32 Participants.
Total Participants = 64 Participants.
- Surgery at the donor site (Only for Control Group participants):
the length of these cuts determined the height of the harvested graft. A third cut was made with a drill on the anterior face of the branch, parallel to the external oblique line, to connect the other
T84.3
Z96.5
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Geistlich Pharma AG
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent; Age 18 years or older; Partial edentulism (up to 4 missing adjacent teeth); Atrophied alveolar ridge with one or more adjacent missing teeth; Atrophied alveolar ridge with residual ridge width of = 4 mm; Sufficient bone height at the surgical site for implant placement
Exclusion criteria
Exclusion criteria: General contraindications for dental and/or surgical treatments; Periodontitis or Peri-implantitis; Probing depth > 4mm at the adjacent teeth; Inadequate oral hygiene (PI>1); Knife-edge morphology of the alveolar ridge; Implants adjacent to the surgical site; Inflammatory disease of oral cavity; Immunological impairment; Allergy to collagen; Diabetes; History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years; Previous, concurrent or planned radiotherapy of head area; Concurrent or previous immunosuppressant, bisphosphonate, high-dose or long-term corticosteroid therapy; Smokers or subjects who did not quit smoking at least 3 months prior to the surgery; Pregnant or lactating women; Women of childbearing age, who are not using a highly effective method of birth control; Participation in an investigational device, drug or biologics study within the last 26 weeks prior to the study start; Participation in any other clinical investigation during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the clinical gain in the width of the ridge 2 mm below the alveolar ridge in 30 weeks after the increase in the horizontal ridge. The ridge width gain (mm) was defined as the ridge width measured at implant placement minus the ridge width measured at the baseline before the bone graft.;Possibility to place an implant after graft surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Early implant failures.;-Need for additional guided bone regeneration in implant placement, assessed through the presence of thin bone remaining in the bone walls surrounding the implant, according to the operator's criteria. ;Postoperative complications, assessed during the postoperative period, through photos, clinical measures in the control consultations and patient reports. ;-Surgery time, measured by the time that was measured in minutes using a timed clock. ;-Patient-centered outcomes, such as pain and, quantity of analgesics, quality related to oral health of life (OHIP-14) and satisfaction with the result of the treatment were, measured through specific questionnaires. | — |
Countries
Brazil
Contacts
Public ContactGiuseppe Romito
Outcome results
None listed