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Completed

NCT Number: NCT05739461

The Effect of Triangular Neck Design on Crestal Bone Loss

The objective of this retrospective study with 5-year follow-up was to compare crestal bone loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography

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Key information

Age range

59 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

About this study

CBL is a multifactorial entity including factors related to patients, surgical technique, prosthetic interventions, and implant design. Thus, new developments in implant micro- and macro-features, such as modifications of surface characteristics and chemistry, type of abutment connection, thread design, and neck design have been introduced over time parallel to recent advances in implantology not only for reducing CBL, but also for preserving buccal bone dimensions around implant. Furthermore, implant neck properties have been considered as a determinant factor involved in maintenance of crestal bone around implant in various trials. Nevertheless, there is no consensus with respect to the design of implant neck for reducing CBL.

The most common implant neck design is the circular one; recently, however, a newly designed implant with a triangular neck (TN) portion was introduced, which has reduction in the neck portion on three sides. This neck design provides compression-free area to alveolar crest during implant insertion to minimize CBL. In addition, TN design also would enhance the BBT by increasing the space between the flat part of the triangle and the buccal bone cortex. Based our previous study with one-year follow-up, despite the implants with novel neck design showed a better crestal bone preservation compared to conventional neck design, long-term clinical trials determining the effect of TN are missing for validating the success of this new design. Unfortunately, the data derived from only very few short-term comparative clinical trials to date do not provide an answer on benefits of TN design over the CN implants regarding preserving crestal bone level.

Thus, this retrospective study with up-to-x-month follow-up aimed to compare CBL and BBT around implants with TN and RN retaining mandibular overdentures. The null hypothesis was that there was a difference in CBL and BBT between two implant designs in the long-term follow-up.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients over 18 years old.
  • Mandibular total edentulism.
  • Presence of sufficient residual bone width (>5 mm) and length (>10 mm).
  • Sufficient keratinized gingiva crestally (≥4 mm).
  • Sufficient interarch space.
  • Sufficient vestibular depth.
  • Patients had their teeth extracted at least three months before surgery.

Exclusion criteria

  • Patients with any systemic disease or condition that can/could compromise osteointegration (cancer, diabetes mellitus, osteopo- rosis, and cardiovascular diseases).
  • Presence of any drug use that could affect bone metabolism.
  • Presence of immunocompromising conditions.
  • Presence of any pathology in the mandible.
  • Allergy to any drugs used in the postoperative period.
  • Patients who are smokers.

Treatment and study plan

dental implant

Other

Dental implants with triangular cross-section neck design

Primary outcomes

  1. comparison of crestal bone loss

    Time frame: February 2023

  2. comparison of buccal bone thickness

    Time frame: February 2023

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

The Effect of Triangular Cross-section Neck Design on Crestal Bone Stability in the Anterior Mandible: A Retrospective Study With a 5-year Follow-up

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2023
Registry last updated
Feb 22, 2023

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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