Efficacy of a Dental Implant System for Immediate Restoration

NCT06651502 | Active Not Recruiting FDA Device

• 1 other identifier: IRB24-0702
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

dental implant; immediate provisionalization

Outcome Measures

Primary Outcomes (1)

• radiographic crestal bone level

  radiographs taken at baseline, 12 weeks following implant placement and at implant final restoration, 1 year after final restoration, and 2 years after final restoration will be analyzed for changes in the crestal bone level

  baseline, 12 weeks after implant, time of final restoration, 1-year post final restoration and 2-year post final restoration

Secondary Outcomes (1)

• Implant Stability

  at the time of implant placement

Study Arms (1)

dental implant placement and immediate temporary restoration

EXPERIMENTAL

1. pre-operative: comprehensive exam, standard-of-care x-rays, cone beam computed tomography (CBCT), dental optical scan 2. intra-operative: dental implant placement and immediate provisionalization 3. 4-week follow-up 4. 12-week impression 5. Delivery of final restoration 6. follow-ups at 1 year and 2-year post-implant restoration

Device: dental implant placement and immediate provisionalization

Interventions

dental implant placement and immediate provisionalization DEVICE

dental implant placement and immediate temporization

dental implant placement and immediate temporary restoration

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead

Study Sites (1)

Harvard Dental Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David Kim, DDS, DMSc

  Harvard School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 21, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)