RECRUITING

Efficacy of a Dental Implant System for Immediate Restoration

Conditions

Missing Teeth dental implant immediate provisionalization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Clinical and Radiographic Evaluations of Hiossen EK III NH Dental Implants

Quick Facts

Study Start:2025-01-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06651502

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.

Ages Eligible for Study:20 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

David Minjoon Kim, DDS, DMSc

CONTACT

(617) 432-1434

dkim@hsdm.harvard.edu

Chia-Yu Chen, DDS, DMSc

CONTACT

(617) 432-1434

Chia-Yu_Chen@hsdm.harvard.edu

Principal Investigator

David Kim, DDS, DMSc

PRINCIPAL_INVESTIGATOR

Harvard School of Dental Medicine

Study Locations (Sites)

Harvard Dental Center

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Harvard Medical School (HMS and HSDM)

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

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 Registration Dates

Study Start Date2025-01-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-01-01

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

dental implant
immediate provisionalization

Additional Relevant MeSH Terms

Missing Teeth