- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614442
Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla
Evaluation of the Effect of Slopped Shoulder Implant Neck Versus Conventional Implant Neck Design on the Crestal Bone Level in the Maxilla: Randomized Clinical Trial (RCT)
Study Overview
Detailed Description
Implant prosthesis allows normal muscle function, and the implant stimulates the bone and maintains its dimensions in a manner similar to healthy natural teeth. Crestal bone loss can result in increased bacterial accumulation resulting in secondary peri-implant inflammation and bone loss which can further result in loss of alveolar support, which in turn can lead to occlusal overload resulting in implant failure. In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching. The authors developed the concept of slopped shoulder implant which results in an inward bone creeping at the coronal part of the implant to be in continuity with the alveolar bone crest.
The rational to use this type of implant allows an increase at residual crestal bone volume around the implant neck and has 3 merits:
- Reduced mechanical stress at the implant neck area;
- Repositioning of gingival papillae on the beveled neck implant (that is the physiologic condition);
- proper vascular supply to the implant investing structure and bone tissue also because of reduced inter-implant space.
The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Good oral hygiene
- Systemically healthy (free from any systemic diseases).
- Adequate native bone to achieve implant primary stability
- Have had the tooth extraction at least 3 months before implant surgery.
- Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery
Exclusion Criteria:
- Smokers
- Pregnant woman
- Had a history of alcoholism or drug abuse within the past 5 years.
- Had bruxism or clenching habits.
- Patients who refused to join the study.
- Had significant untreated periodontal disease or history of treated periodontitis.
- Had caries on teeth adjacent to the prospective implant site.
- Periapical infection.
- localized radiation therapy of the oral cavity; antitumor chemotherapy.
- poor oral hygiene
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: slopped shoulder implant
The osteotomy site will be prepared using appropriate drill sizes with flapless approach, The implant (conventional neck implant design )will be inserted till the platform will be flushed with the crestal bone, The primary stability will be checked using torque wrench
|
different implant design to enhance soft and hard tissue outcome
|
Active Comparator: conventional implant with flat platform
inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform).
The primary stability will be checked using torque wrench
|
different implant design to enhance soft and hard tissue outcome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pink esthetic score(PES)
Time Frame: 8 months
|
soft tissue esthetics scale : Seven variables will be evaluated vs. a natural reference tooth: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture.
Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14.
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
crestal bone resorption
Time Frame: 8 months
|
bone loss around implant neck will be measured using (CBCT) cone beam computed tomography.
On CBCT scans, the amount of bone resorption in the buccal, lingual/palatal, mesial and distal surfaces will be determined by measuring the distance from the platform of the implant to the alveolar crest (normal group: 0-1.5mm, mild bone loss: 1.6-3mm, moderate bone loss: 3.1-4.5mm
and severe bone loss: >4.5mm)
|
8 months
|
implant stability
Time Frame: 8 months
|
osteointegration of dental implant using (periotest device ).Periotest value range:
|
8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- platform switching 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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