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

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ClinicalTrials.gov Identifier: NCT03614442
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hosam Ahmed Sharawi Shehabeldin, Cairo University

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.

Condition or disease Intervention/treatment Phase
Missing Tooth Other: slopped shoulder implant Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: the design of the dental implant
Primary Purpose: Treatment
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)
Estimated Study Start Date : July 30, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Hosam Ahmed Sharawi Shehabeldin, B.Sc. in Oral and Dental Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03614442     History of Changes
Other Study ID Numbers: platform switching 2018
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities