Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla

NCT ID: NCT03614442

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2018-09-01

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

Conditions

Missing Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

slopped shoulder implant

Intervention Type: OTHER

different implant design to enhance soft and hard tissue outcome

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

Group Type: ACTIVE_COMPARATOR

slopped shoulder implant

Intervention Type: OTHER

different implant design to enhance soft and hard tissue outcome

Interventions

slopped shoulder implant

different implant design to enhance soft and hard tissue outcome

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hosam Ahmed Sharawi Shehabeldin

B.Sc. in Oral and Dental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

platform switching 2018

Identifier Type: -

Identifier Source: org_study_id