Efficacy of a Dental Implant System for Immediate Restoration

Description

The primary objective of this study is to observe the performance of an implant system with a new surface (EK III NH dental implants) over a period of two years. The implants will be placed in the upper and lower jaws of patients with missing teeth and immediately given a temporary restoration. The investigators will document the performance of the implants through regular dental check-ups and X-rays.

Conditions

Missing Teeth

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Study Overview

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Study Details

Study overview

The primary objective of this study is to observe the performance of an implant system with a new surface (EK III NH dental implants) over a period of two years. The implants will be placed in the upper and lower jaws of patients with missing teeth and immediately given a temporary restoration. The investigators will document the performance of the implants through regular dental check-ups and X-rays.

Clinical and Radiographic Evaluations of Hiossen EK III NH Dental Implants

Efficacy of a Dental Implant System for Immediate Restoration

Condition
Missing Teeth
Intervention / Treatment

-

Contacts and Locations

Boston

Harvard Dental Center, Boston, Massachusetts, United States, 02115

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female, between 20-80 years of age, who request dental implant treatment options to replace missing teeth as part of comprehensive dental care
  • * Subjects are willing to sign an informed consent, participate, and return for follow-up visits.
  • * Subjects without significant medical history and currently not on medications that might complicate the results
  • * Subjects who do not meet all the inclusion criteria or will not cooperate with the protocol schedule.
  • * Subjects who received and failed a previously placed dental implant.
  • * Subjects who require a bone and soft tissue grafting procedure prior to or at the time of the implant placement.
  • * Subjects with significant untreated periodontal disease, caries, infection, or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
  • * Subjects who have used nicotine-containing products within three weeks prior to surgery.
  • * Subjects who are insulin-dependent diabetic or if their Hgb1c levels \> 6.5%.
  • * Subjects with a history of malignancy within the past five years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
  • * Subjects who are nursing or pregnant.
  • * Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that is known to affect bone turnover.
  • * Subjects with diseases affecting bone metabolism (excluding idiopathic osteoporosis).
  • * Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
  • * Acutely infected defect site.

Ages Eligible for Study

20 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Harvard Medical School (HMS and HSDM),

David Kim, DDS, DMSc, PRINCIPAL_INVESTIGATOR, Harvard School of Dental Medicine

Study Record Dates

2026-12-31