Missing TeethNCT06651502
Efficacy of a Dental Implant System for Immediate Restoration
A study testing dental implant placement and immediate provisionalization in people with Missing Teeth, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Missing Teeth
- What is being tested?
- dental implant placement and immediate provisionalization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluations of Hiossen EK III NH Dental Implants
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.
Read the detailed description
Treating patients with missing teeth using dental implants is now a common and reliable approach in modern dentistry. Significant improvement has been made in implant shape design, implant surface optimization and surgical techniques to ensure predictable bonding between the titanium implants and bone (osseointegration). Modern implants are designed to be stable both immediately after placement (primary stability) and over time as they bond with the bone (secondary stability). Factors such as the quality and quantity of the patients' bone, the design of the implant, and the surgical technique used can all affect primary stability. The implant's secondary stability is affected by many of these same factors but has also been demonstrated to be influenced by other patient-related factors, including wound site blood supply, as well as the surface of the implants. Various surface treatments, like titanium plasma spraying, acid etching, hydroxyapatite coating, and sandblasting, have been developed to improve this bond (secondary stability). For instance, porous coatings can help by allowing the bone to grow into the implant, while hydroxyapatite coatings are biocompatible and encourage bone formation. Research has shown that different surface treatments can lead to different cellular responses, affecting how bone cells (osteoblasts) behave and develop around the implant.
In clinical practice, several methods are used to measure how stable an implant is immediately after placement, known as primary stability. These methods include measuring the insertion torque and using resonance frequency analysis (RFA). To assess secondary stability, or osseointegration, which refers to the long-term bonding of the implant to the bone, various techniques are used. These include RFA, mechanical disruption testing, and histomorphometric analysis. Additionally, changes in the bone level around the implant are commonly observed through X-rays as a non-invasive way to monitor the long-term success of dental implants. Human histological evidence of successfully osseointegrated implants is extremely rare in the literature because there are few opportunities to retrieve implants in humans.
Hiossen is a leading and rapidly growing implant manufacturer, with its systems used in over 70 countries. Recently, the company launched a new implant system called EK III NH. This system features a sand-blasted and acid-etched (SA) surface with a nano-hydroxyapatite (NH) coating. This special surface allows for faster bone healing and reduces the time before the implant can be loaded compared to other types of implant surfaces. The company's internal studies have shown that this surface treatment creates a very thin coating layer on the implant that is hydrophilic, meaning it attracts water, which improves the bonding process with 30% higher osseointegration than conventional SA surfaces. In addition, the new EK III NH system includes design improvements compared to the current ET SA implant system by the same company. New features include a buttress thread, 0.9 mm pitch, reverse helical cutting edge, and an improved internal hex connection, making the system easier to achieve good mechanical bonding immediately (primary stability) and easier to restore.
The investigators propose conducting a short-term clinical study to examine how well the bone around the EK III NH implants is maintained when they are immediately restored with a temporary crown. This study aims to assess the benefits of using the EK III NH implants in dental treatments.
- Conditions
- Missing Teeth
- Being tested
- dental implant placement and immediate provisionalization
- Keywords
- dental implant, immediate provisionalization
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placement and immediate provisionalizationDevice
dental implant placement and immediate temporization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: dental implant placement and immediate provisionalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Implant stability at the time of implant placement will be recorded using implant stability quotient. The usual range is between 50~80, the higher number indicates better stability.
Measured: at the time of implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kim, Harvard Medical School (HMS and HSDM)
- Investigators
- David Kim, DDS, DMSc, Principal investigator, Harvard School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651502
- Sponsor's protocol ID
- IRB24-0702
- Status last verified
- Feb 2026
- First submitted
- 30 Sep 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluations of Hiossen EK III NH Dental Implants
- ClinicalTrials.gov ID
- NCT06651502
- Acronym / sponsor ID
- IRB24-0702
- Conditions
- Missing Teeth
- Keywords
- dental implant, immediate provisionalization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treating patients with missing teeth using dental implants is now a common and reliable approach in modern dentistry. Significant improvement has been made in implant shape design, implant surface optimization and surgical techniques to ensure predictable bonding between the titanium implants and bone (osseointegration). Modern implants are designed to be stable both immediately after placement (primary stability) and over time as they bond with the bone (secondary stability). Factors such as the quality and quantity of the patients' bone, the design of the implant, and the surgical technique used can all affect primary stability. The implant's secondary stability is affected by many of these same factors but has also been demonstrated to be influenced by other patient-related factors, including wound site blood supply, as well as the surface of the implants. Various surface treatments, like titanium plasma spraying, acid etching, hydroxyapatite coating, and sandblasting, have been developed to improve this bond (secondary stability). For instance, porous coatings can help by allowing the bone to grow into the implant, while hydroxyapatite coatings are biocompatible and encourage bone formation. Research has shown that different surface treatments can lead to different cellular responses, affecting how bone cells (osteoblasts) behave and develop around the implant.
In clinical practice, several methods are used to measure how stable an implant is immediately after placement, known as primary stability. These methods include measuring the insertion torque and using resonance frequency analysis (RFA). To assess secondary stability, or osseointegration, which refers to the long-term bonding of the implant to the bone, various techniques are used. These include RFA, mechanical disruption testing, and histomorphometric analysis. Additionally, changes in the bone level around the implant are commonly observed through X-rays as a non-invasive way to monitor the long-term success of dental implants. Human histological evidence of successfully osseointegrated implants is extremely rare in the literature because there are few opportunities to retrieve implants in humans.
Hiossen is a leading and rapidly growing implant manufacturer, with its systems used in over 70 countries. Recently, the company launched a new implant system called EK III NH. This system features a sand-blasted and acid-etched (SA) surface with a nano-hydroxyapatite (NH) coating. This special surface allows for faster bone healing and reduces the time before the implant can be loaded compared to other types of implant surfaces. The company's internal studies have shown that this surface treatment creates a very thin coating layer on the implant that is hydrophilic, meaning it attracts water, which improves the bonding process with 30% higher osseointegration than conventional SA surfaces. In addition, the new EK III NH system includes design improvements compared to the current ET SA implant system by the same company. New features include a buttress thread, 0.9 mm pitch, reverse helical cutting edge, and an improved internal hex connection, making the system easier to achieve good mechanical bonding immediately (primary stability) and easier to restore.
The investigators propose conducting a short-term clinical study to examine how well the bone around the EK III NH implants is maintained when they are immediately restored with a temporary crown. This study aims to assess the benefits of using the EK III NH implants in dental treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dental implant placement and immediate temporary restoration | Experimental | Device: dental implant placement and immediate provisionalization1. 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implant placement and immediate provisionalizationdental implant placement and immediate temporization | Device | dental implant placement and immediate temporary restoration |
Primary outcome
radiographic crestal bone level
Time frame: baseline, 12 weeks after implant, time of final restoration, 1-year post final restoration and 2-year post final restoration
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
1 secondary outcome
Implant Stability
Time frame: at the time of implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kim, DDS, DMSc principal investigator
Harvard School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant placement and immediate provisionalization in people with Missing Teeth, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic crestal bone level (time frame: baseline, 12 weeks after implant, time of final restoration, 1-year post final restoration and 2-year post final restoration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.