Immediate Dental Implant LoadingNCT06083506
Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System
A study testing NOVALOC TiN retained maxillary overdenture in people with Immediate Dental Implant Loading and Denture, Complete, run by West Virginia University at 1 site in United States.
Trial summary
Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in order to improve the stability of the denture, along with the satisfaction of the patient. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant Loading, Denture, Complete
- What is being tested?
- NOVALOC TiN retained maxillary overdenture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 15 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully edentulous maxilla
- The implant site has to be healed for at least 4 months after extraction
- Wearing complete dentures deemed adequate
- Orthopantomogram available (OPT)
- Adequate amount of bone at least at the 2nd premolar position to house a 3.75 x 10 mm implant
- No bone grafting required
- Implant IT ≥ 20 N/cm
Who cannot join
- Conditions requiring chronic routine prophylactic use of antibiotics
- Conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- Bleeding disorders
- History of neoplastic disease requiring use of radiation or chemotherapy
- Metabolic bone disorders
Show all 24Show fewer
- Uncontrolled endocrine disorder
- Use of any investigational drug or device within the 30-day period prior to implant surgery
- Smoking more than 10 cigarettes a day
- Alcoholism or drug abuse
- Patient infected with HIV
- Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.
- Local exclusion criteria:
- Local inflammation including untreated periodontitis
- Mucosal disease such as erosive lichen planus
- History of local irradiation therapy
- Osseous lesion
- Severe bruxism and clenching habits
- Active infection with suppuration or fistula track
- Persistent intraoral infection
- Lack of primary stability <20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol.
- Inadequate oral hygiene or unmotivated home care.
- Bone grafting
- Inadequate bone volume for implants insertion as measured on the per-treatment CBCT.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System: Open Ended Prospective Study
Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in order to improve the stability of the denture, along with the satisfaction of the patient. Usually, the dental implants are inserted and then a period of 3-6 months is waited before any denture is connected to them. Recent studies have demonstrated that connecting the lower denture to the implants immediately after the implant placement, leads to an improvement in the result, with a social and psychological benefit for the patient. Therefore, the aim of this research project is to evaluate the application of the immediate connections of the implants for the upper dentures. 15-40 patients wearing an upper denture will receive 4 dental implants and the denture will be immediately connected. To simplify the surgical procedure, the implants will be placed without exposing the bone. This surgical technique is called guided surgery. Secondary objective of this research project will be the evaluation of the precision of the implant positioning, using this specific technique. The patients will be followed up for 12 months, for the implant and denture evaluation, as well as the evaluation of patient satisfaction and impact on quality of life through questionnaires.
- Being tested
- NOVALOC TiN retained maxillary overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVALOC TiN retained maxillary overdentureDevice
4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture
| Study group | Role | What they receive |
|---|---|---|
| NOVALOC TiN | Other | Each subject will receive 4 implants. Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture. Receives: Device: NOVALOC TiN retained maxillary overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Bone Level (RBL) Change
RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
Measured: Baseline to 6 months post implant
Radiographic Bone Level (RBL) Change
RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
Measured: Baseline to 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start3 Jan 2019
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Immediate Dental Implant LoadingStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Sponsor
- Investigators
- Arif Salman, BDS, MDSc, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083506
- Sponsor's protocol ID
- 1801929813
- Status last verified
- Jul 2025
- First submitted
- 3 Oct 2023
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System: Open Ended Prospective Study
- ClinicalTrials.gov ID
- NCT06083506
- Acronym / sponsor ID
- 1801929813
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in order to improve the stability of the denture, along with the satisfaction of the patient. Usually, the dental implants are inserted and then a period of 3-6 months is waited before any denture is connected to them. Recent studies have demonstrated that connecting the lower denture to the implants immediately after the implant placement, leads to an improvement in the result, with a social and psychological benefit for the patient. Therefore, the aim of this research project is to evaluate the application of the immediate connections of the implants for the upper dentures. 15-40 patients wearing an upper denture will receive 4 dental implants and the denture will be immediately connected. To simplify the surgical procedure, the implants will be placed without exposing the bone. This surgical technique is called guided surgery. Secondary objective of this research project will be the evaluation of the precision of the implant positioning, using this specific technique. The patients will be followed up for 12 months, for the implant and denture evaluation, as well as the evaluation of patient satisfaction and impact on quality of life through questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOVALOC TiN | Other | Device: NOVALOC TiN retained maxillary overdentureEach subject will receive 4 implants. Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fully edentulous maxilla
- The implant site has to be healed for at least 4 months after extraction
- Wearing complete dentures deemed adequate
- Orthopantomogram available (OPT)
- Adequate amount of bone at least at the 2nd premolar position to house a 3.75 x 10 mm implant
Key exclusion criteria (24 listed)
- Conditions requiring chronic routine prophylactic use of antibiotics
- Conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- Bleeding disorders
- History of neoplastic disease requiring use of radiation or chemotherapy
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 |
|---|---|---|
| NOVALOC TiN retained maxillary overdenture4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture | Device | NOVALOC TiN |
Primary outcome
Radiographic Bone Level (RBL) Change
Time frame: Baseline to 6 months post implant
RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
Radiographic Bone Level (RBL) Change
Time frame: Baseline to 12 months post implant
RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Arif Salman, BDS, MDSc principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVALOC TiN retained maxillary overdenture in people with Immediate Dental Implant Loading and Denture, Complete, run by West Virginia University 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 7 inclusion and 24 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: finished, as of the sponsor's last update on 20 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Bone Level (RBL) Change (time frame: Baseline to 6 months post implant). The study lists 2 primary outcomes in all. 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 20 Jul 2025.