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Completed

NCT Number: NCT02761226

Clinical and Radiographic Evaluation of Crestal Bone Loss Around Implant With or Without Platform Switching Design

Implants have become the preferred method of single tooth replacement these days, patients receiving implant treatments not only expect restoration of masticatory function, they also expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. To maintain long-term implant stability, it is important to minimize bone loss around the implant, as well as the soft tissue atrophy that accompanies it.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The peri-implant bone level has been used as one of the criteria to assess the success of dental implants, Platform switching (PLS) for maintaining peri-implant bone levels has gained popularity among implant manufacturers over the last few years. However, the assumption that the inward shifting of the implant- abutment junction may preserve crestal bone was primarily based on serendipitous finding rather than scientific evidence.

It is known that saucerization around an implant occurs following abutment connection using a submerged implant with a butt joint (a two-stage approach), such as the Branemark implant. The nature of saucerization varies according to implant type (one-stage or two-stage) and abutment connection type. they have reported that the factors that are the most likely causes of early crestal bone loss around implants are:

  • The micro-gap,
  • The implant crest module,
  • Occlusal overload, and
  • The biologic width around the dental implant. At the Toronto Conference 1998, the consensus with respect to bone loss around the implant was that bone loss of up to approximately 2 mm during the first year of implant function is acceptable, and at this level the implant is regarded as successful. There have been many reports on studies to ascertain the causes of bone loss around implants and clinical techniques to prevent it. Some reports published in 2005 and 2006 state that the platform switching technique, a technique in which an abutment that is one-size smaller than the implant platform is placed, prevents bone loss around the implant. However, there are only a few reports on the mechanism of action or the extent of bone loss prevention, and as such, it is difficult to say that the effect of PLS has been thoroughly examined. This review article examines the PLS technique and the bone loss preventive effect.

A lot of clinical studies discussed the concept of platform switching was extensively studied histologically and biomechanically. In histomorphometric studies in dogs was no significant difference in the marginal bone level around platform- switched and -matched implants after 28 days of healing. In contrast, other studies reported a significantly less bone loss around platform-switched implants after a loading period of 2 to 6months.

However, there is no consistency among the studies with respect to the study design (e.g. the location and depth of the implant, and controlled/non-controlled), and as such, it is difficult to evaluate all of these studies using the same evaluation method.

The review and meta-analysis show that platform switching may preserve interimplant bone height and soft tissue levels. The degree of marginal bone resorption is inversely related to the extent of the implant- abutment mismatch. But still no general agreement to confirm the validity of this concept, so Further long-term, well-conducted, randomized controlled studies are needed to confirm the validity of this concept.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than18 yrs.
  • Patients with missing teeth in the posterior maxilla (from the 1st premolar to 2nd Molar) bilaterally in need for fixed implant-supported prosthesis.
  • Full mouth plaque score and full mouth bleeding score ˂25 %
  • Patients with adequate bone quality and quantity at the implant site
  • Patients with systematic healthy.
  • Non-smokers or those smoking ˂10 cigarettes/day
  • Patients who were cooperative, motivated, and hygiene conscious and willing to return for multiple follow-up appointments (up to 9 months after prosthetic loading).

Exclusion criteria

I) General:-

  • Patients with any systemic condition that may contraindicate implant therapy.
  • Patients with a history of Bisphosphonate therapy
  • Pregnant and lactating patients
  • Alcohol and drug abuse
  • Parafunctional habits that produce overload on the implant such as bruxism and clenching.

II) Local:-

  • Local inflammation or infection at implant site.
  • Untreated periodontitis
  • Local irradiation therapy
  • History of implant failure as well as unhealed extraction socket
  • Inadequate keratinized gingiva or thin gingival biotype.
  • Inadequate bone height or width.
  • Insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.

Treatment and study plan

Platform Matched Design (Group A)

Procedure

10 patients with missing upper posterior teeth will receive dental implant with platform matched design (the patients will receive implant 4.2mm with same abutment diameter 4.2mm)

Other names: group 1

Platform Switching Design (Group B)

Procedure

10 patients with missing upper posterior teeth will receive dental implant with platform switching design(the patients will receive implant 4.2mm with smaller abutment diameter 3.5 mm

Other names: group 2

Primary outcomes

  1. crestal bone loss

    Time frame: 9 months

    assessment crestal bone loss after 9 months after crown placement

Secondary outcomes

  1. implant stability

    Time frame: 9 months

    assessment implant placement by periotest at abutment instillation and after 9 month of crown placement

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Crestal Bone Loss Around Implant With or Without Platform Switching Design (Randomized Clinical Trial, Split Mouth Design)

Acronym: PS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 4, 2016
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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