Clinical trial NCT03614442: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Missing Tooth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: pink esthetic score(PES)
timeFrame: 8 months
Secondary outcomes:
measure: crestal bone resorption
timeFrame: 8 months
measure: implant stability
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
References: