Implant Surface, Surgical Technique
Conditions
Brief summary
The aim is to clinically and radiographically assess a novel wedge implant placed in narrow ridges. * 60 wedge implants (Rex Implants, Columbus, OH, USA) will be placed using Piezosurgery® following either a bone consumption (n=30) or bone expansion technique (n=30). Each group (bone consumption and bone expansion) will be divided into 2 surface treatments: machined transcortical portion (n=15) and roughened transcortical portion (n=15). * Record the time needed to place each implant. * ISQ will be evaluated at Day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement. * Periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5 years after loading to assess marginal bone stability. * Buccal bone height and lingual and buccal bone thickness will be recorded post-intervention, at the time of functional loading, and at 12, 36, and 60 months after loading with CBCT. * Digital impressions will be taken post-operatively, at loading and at 12 months after loading to monitor gingival profile.
Interventions
PROCEDUREBone Consumption
The surgery will be done using a bone consumption protocol
PROCEDUREBone expansion
implants will be placed after a bone expansion protocol
Sponsors
Christian Makary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 62 Years
Healthy volunteers
Yes
Inclusion criteria
1. Partially or totally edentulous patients presenting indications for a prosthetic rehabilitation supported by the upper or lower jaw implants on the basis of an accurate diagnosis and treatment planning; 2. the bone crest must be completely healed (at least six months after the loss of teeth); 3. the residual bone crest must have a width between 3 and 5 mm; 4. presence of at least 10 mm of bone height available for implant placement; 5) patient age \> 18 years; 6\) the patient must not wear any type of removable dentures on the treated area; 7) the patient must be capable of following the study protocol; and 8) written informed consent must be provided
Exclusion criteria
1. acute myocardial infarction within the last two months; 2. Uncontrolled coagulation disorders; 3. uncontrolled diabetes (HBA1c\> 7.5); 4. radiation therapy to the head \\ neck region in the last 24 months; 5. immunocompromised patients, HIV positive or receiving chemotherapy in the last five years; 6. past or present treatment with intravenous bisphosphonates; 7. psychological or psychiatric problems; 8. abuse of alcohol or drugs;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability | 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement. | Implant stability quotient evaluation |
| Bone stability | At 6 months, and at 12, 36, and 60 months after loading | Periapical radiograph and CBCT |
| Gingival profile monitoring | Day 0 of surgery, at 6 months and at 12 months. | Digital impression superimposition |
Countries
Lebanon
Outcome results
None listed