Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla
Primary Purpose
Missing Tooth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
slopped shoulder implant
Sponsored by
About this trial
This is an interventional treatment trial for Missing Tooth
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
slopped shoulder implant
conventional implant with flat platform
Arm Description
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
inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench
Outcomes
Primary Outcome Measures
pink esthetic score(PES)
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.
Secondary Outcome Measures
crestal bone resorption
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)
implant stability
osteointegration of dental implant using (periotest device ).Periotest value range:
8.0 to0.0 Good osseointegration
0.1 to +9.9 the implant can be loaded
10.0 or higher loading of the implant might or might not be possible
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03614442
Brief Title
Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2018 (Anticipated)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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 aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
the design of the dental implant
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
slopped shoulder implant
Arm Type
Experimental
Arm Description
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
Arm Title
conventional implant with flat platform
Arm Type
Active Comparator
Arm Description
inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench
Intervention Type
Other
Intervention Name(s)
slopped shoulder implant
Intervention Description
different implant design to enhance soft and hard tissue outcome
Primary Outcome Measure Information:
Title
pink esthetic score(PES)
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
crestal bone resorption
Description
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)
Time Frame
8 months
Title
implant stability
Description
osteointegration of dental implant using (periotest device ).Periotest value range:
8.0 to0.0 Good osseointegration
0.1 to +9.9 the implant can be loaded
10.0 or higher loading of the implant might or might not be possible
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla
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