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

Missing Tooth Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03614442
• Other study ID #: platform switching 2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Missing Tooth
• Tooth Loss

Intervention

Other:
• slopped shoulder implant
different implant design to enhance soft and hard tissue outcome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 months
Secondary	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)	8 months
Secondary	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	8 months