Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges
NCT ID: NCT06178536
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2021-06-03
2023-12-01
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rex implant machined transcortical portion
Implants in these group will have a machined portion at the neck of the implant
Bone Consumption
The surgery will be done using a bone consumption protocol
Bone expansion
implants will be placed after a bone expansion protocol
Rex implant roughened transcortical portion
Rex implants with a rough surface until the neck of the implant
Bone Consumption
The surgery will be done using a bone consumption protocol
Bone expansion
implants will be placed after a bone expansion protocol
Interventions
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Bone Consumption
The surgery will be done using a bone consumption protocol
Bone expansion
implants will be placed after a bone expansion protocol
Eligibility Criteria
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Inclusion Criteria
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
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;
35 Years
62 Years
ALL
Yes
Sponsors
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Christian Makary
OTHER
Responsible Party
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Christian Makary
Professor
Locations
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Saint Joseph University
Beirut, , Lebanon
Countries
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Other Identifiers
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XFMD128
Identifier Type: -
Identifier Source: org_study_id