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Clinical Trials/NCT03614442
NCT03614442
Unknown
Not Applicable

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)

Cairo University0 sites16 target enrollmentJuly 30, 2018
ConditionsMissing Tooth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Missing Tooth
Sponsor
Cairo University
Enrollment
16
Primary Endpoint
pink esthetic score(PES)
Last Updated
7 years ago

Overview

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: 1. Reduced mechanical stress at the implant neck area; 2. Repositioning of gingival papillae on the beveled neck implant (that is the physiologic condition); 3. 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

Registry
clinicaltrials.gov
Start Date
July 30, 2018
End Date
September 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hosam Ahmed Sharawi Shehabeldin

B.Sc. in Oral and Dental Medicine

Cairo University

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

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • crestal bone resorption(8 months)
  • implant stability(8 months)

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