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

July 30, 2018 updated by: Hosam Ahmed Sharawi Shehabeldin, Cairo University

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
different implant design to enhance soft and hard tissue outcome
Active Comparator: 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
different implant design to enhance soft and hard tissue outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
crestal bone resorption
Time Frame: 8 months
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
implant stability
Time Frame: 8 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 30, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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