Edentulous JawNCT05082038
Mandibular Full-arch Rehabilitation With Internal Hexagonal and Conical Connection Implants
A study testing Mandibular partial rehabilitation with IF Tapared implants and Mandibular partial rehabilitation with CF Tapared implants in people with Edentulous Jaw, run by Neodent at 1 site in Brazil.
Trial summary
Nuvo Tapered IF (internal hexagonal connection) and CF (conical connextion) Implants were designed for the the oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Mandibular partial rehabilitation with IF Tapared implants and Mandibular partial rehabilitation with CF Tapared implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Sep 2021to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who qualify for mandibular rehabilitation by means of full-arch prostheses supported by two Nuvo Tapered IF implants and two Tapered CF implants
Who cannot join
- Contraindications according to the Instructions for Use of the device will be applied, as follows:
- Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium;
- Presence of acute inflammatory or infectious processes in live tissue;
- Unsuitable bone volume and/or quality;
- Systemic complications or diseases such as: bone metabolism disorders, blood clotting disorders, unsuitable healing capacity, insufficient oral hygiene, incomplete jawbone growth, patient uncooperative and not motivated, abuse of drugs or alcohol, psychosis, prolonged functional disorders which resist any treatment with medications, xerostomia, weakened immunological system, diseases which require the use of steroids, endocrinological diseases, pregnancy.
- The research does not involve minors, or women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mandibular Full-arch Rehabilitation With Internal Hexagonal and Conical Connection Implants: Randomized Split-mouth Clinical Trial
Nuvo Tapered IF (internal hexagonal connection) and CF (conical connextion) Implants were designed for the the oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities.
The aim of the study is to confirm the long-term safety and clinical performance of implants and abutments of Nuvo IF and CF in daily dental practice setting, by means of prospective collection of clinical data in randomized clinical trial using these devices.
Devices will be used , according to manufacturer indications in the IFU. Patients will be followed for 36 months after implant loading.
Read the detailed description
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil. The sample will be prospectively selected and will consist of 18 patients, presenting 18 years of age or more, complete edentulism, who qualify for mandibular rehabilitation by means of full-arch prostheses supported by two Nuvo Tapered IF implants and two Tapered CF implants .Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.
Before study site activation, the implants of each patient in the study will be randomly allocated (allocation ratio 1:1), so that each patient receives two implants from each group, on each side of the mandibular arch (Group IF: Tapered Implants with internal hexagonal connection; Group CF: Tapered Implants with conical connection). A blocked randomization list will be generated, where the sequence within block corresponds to the quadrant each group of implants shall be inserted (1:right quadrant; 2: left quadrant). The Randomization List will be kept by the Sponsor in the Trial Master File. Although this study is not blinded, access to the randomization list will not be available to the study centers or to the subjects.
Treatment provided to the subjects will be the responsibility of an appropriately qualified dental practitioners (principal investigator and coinvestigator) to provide the relevant patient care under clinical study conditions, In the mandible, four implants will be placed under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer, being two Tapered IF implants on one side and two Tapered CF implants on the other, according to the established by the randomization results. The implants will be placed at preferably in an axial position for the medial implants and distally angled for the distal ones, depending on bone availability.
Immediately after implant placement, the final insertion torque shall be recorded. The selection of the prosthetic component and loading protocol (late or immediate) shall be conducted according to the need of each subject and to the manufacturer's instructions (IFU). Thus, implant immediate loading may be performed (at the discretion of the surgeon) when all implants present primary stability of at least 35 N.cm. Maxillary rehabilitation will be performed by means of confection of muco-supported dentures.
Data concerning the studied variables (mandibular rehabilitation) will be collected following the procedures and assessments plan by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); TP - Implants placement; T0 - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, thereafter.
Panoramic radiographs, lateral cephalometric radiographs and computed tomography (CT) scans will be obtained from the region of interest prior to surgery, for the surgical planning. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (TP - immediately or within 1 week after implant placement) and during the post-operative stages (T0, T6, T12, T24 and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.
- Conditions
- Edentulous Jaw
- Being tested
- Mandibular partial rehabilitation with IF Tapared implants, Mandibular partial rehabilitation with CF Tapared implants
- Keywords
- dental implants, oral rehabilitation
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular partial rehabilitation with IF Tapared implantsDevice
2 IF Tapared Implants (Group IF) on one side of the mandible
Mandibular partial rehabilitation with CF Tapared implantsDevice
2 CF Tapared Implants (Group CF) on the other side of the mandible
| Study group | Role | What they receive |
|---|---|---|
| Group IF | Other | Two Tapered IF implants will be installed in one side of the mandible Receives: Device: Mandibular partial rehabilitation with IF Tapared implants |
| Group CF | Other | Two Tapered IF implants will be installed in the other side of the mandible Receives: Device: Mandibular partial rehabilitation with CF Tapared implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periimplant bone level change
Amount of Periimplant bone level change 36 months after loading.
Measured: up to 36 months
Secondary outcomes (9)
Implant survival rate
Survival will be defined as no loss of the implant at each follow-up
Measured: up to 36 months
Prosthetic survival
Prosthetic survival will be assessed as the final prosthesis remaining in situ at each follow-up.
Measured: 6, 12, 24 and 36 months
Soft tissue evaluation
visible plaque index, maginal bleeding index, bleeding on probing, gingival index, keratinized tissue height measurements
Measured: up to 36 months
Patient satisfaction
The Portuguese translation of OHIP-EDENT questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment.
Measured: up to 36 months
Clinician satisfaction
The assessment will be performed by means of a questionnaire using a visual analog scale (VAS) in the form of a 10 cm horizontal line, where 0 (left end) indicates minimum satisfaction and 10 (right end) indicates maximum satisfaction
Measured: up to 36 months
Adverse events
Determined by inquiring with the patient and clinical evaluation
Measured: up to 36 months
Device deficiences
Determined by inquiring with the patient and clinical evaluation
Measured: up to 36 months
Implant success rate
- Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation);
- Absence of a recurrent periimplant infection with suppuration (infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics);
- Absence of implant mobility on manual palpation;
- Absence of any continuous periimplant radiolucency.
Measured: up to 36 months
Prosthetic success rate
Success will be defined as the prosthesis that remained unchanged and did not require any intervention
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start23 Sep 2021
- Primary completion1 May 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neodent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Waleska Caldas, PhD, Study chair, Neodent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082038
- Sponsor's protocol ID
- CS.I.002
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Full-arch Rehabilitation With Internal Hexagonal and Conical Connection Implants: Randomized Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT05082038
- Acronym / sponsor ID
- CS.I.002
- Conditions
- Edentulous Jaw
- Keywords
- dental implants, oral rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 18 Oct 2021 (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.
Nuvo Tapered IF (internal hexagonal connection) and CF (conical connextion) Implants were designed for the the oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities.
The aim of the study is to confirm the long-term safety and clinical performance of implants and abutments of Nuvo IF and CF in daily dental practice setting, by means of prospective collection of clinical data in randomized clinical trial using these devices.
Devices will be used , according to manufacturer indications in the IFU. Patients will be followed for 36 months after implant loading.
Detailed description
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil. The sample will be prospectively selected and will consist of 18 patients, presenting 18 years of age or more, complete edentulism, who qualify for mandibular rehabilitation by means of full-arch prostheses supported by two Nuvo Tapered IF implants and two Tapered CF implants .Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.
Before study site activation, the implants of each patient in the study will be randomly allocated (allocation ratio 1:1), so that each patient receives two implants from each group, on each side of the mandibular arch (Group IF: Tapered Implants with internal hexagonal connection; Group CF: Tapered Implants with conical connection). A blocked randomization list will be generated, where the sequence within block corresponds to the quadrant each group of implants shall be inserted (1:right quadrant; 2: left quadrant). The Randomization List will be kept by the Sponsor in the Trial Master File. Although this study is not blinded, access to the randomization list will not be available to the study centers or to the subjects.
Treatment provided to the subjects will be the responsibility of an appropriately qualified dental practitioners (principal investigator and coinvestigator) to provide the relevant patient care under clinical study conditions, In the mandible, four implants will be placed under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer, being two Tapered IF implants on one side and two Tapered CF implants on the other, according to the established by the randomization results. The implants will be placed at preferably in an axial position for the medial implants and distally angled for the distal ones, depending on bone availability.
Immediately after implant placement, the final insertion torque shall be recorded. The selection of the prosthetic component and loading protocol (late or immediate) shall be conducted according to the need of each subject and to the manufacturer's instructions (IFU). Thus, implant immediate loading may be performed (at the discretion of the surgeon) when all implants present primary stability of at least 35 N.cm. Maxillary rehabilitation will be performed by means of confection of muco-supported dentures.
Data concerning the studied variables (mandibular rehabilitation) will be collected following the procedures and assessments plan by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); TP - Implants placement; T0 - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, thereafter.
Panoramic radiographs, lateral cephalometric radiographs and computed tomography (CT) scans will be obtained from the region of interest prior to surgery, for the surgical planning. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (TP - immediately or within 1 week after implant placement) and during the post-operative stages (T0, T6, T12, T24 and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group IF | Other | Device: Mandibular partial rehabilitation with IF Tapared implantsTwo Tapered IF implants will be installed in one side of the mandible |
| Group CF | Other | Device: Mandibular partial rehabilitation with CF Tapared implantsTwo Tapered IF implants will be installed in the other side of the mandible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who qualify for mandibular rehabilitation by means of full-arch prostheses supported by two Nuvo Tapered IF implants and two Tapered CF implants
Key exclusion criteria (6 listed)
- Contraindications according to the Instructions for Use of the device will be applied, as follows:
- Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium;
- Presence of acute inflammatory or infectious processes in live tissue;
- Unsuitable bone volume and/or quality;
- Systemic complications or diseases such as: bone metabolism disorders, blood clotting disorders, unsuitable healing capacity, insufficient oral hygiene, incomplete jawbone growth, patient uncooperative and not motivated, abuse of drugs or alcohol, psychosis, prolonged functional disorders which resist any treatment with medications, xerostomia, weakened immunological system, diseases which require the use of steroids, endocrinological diseases, pregnancy.
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 |
|---|---|---|
| Mandibular partial rehabilitation with IF Tapared implants2 IF Tapared Implants (Group IF) on one side of the mandible | Device | Group IF |
| Mandibular partial rehabilitation with CF Tapared implants2 CF Tapared Implants (Group CF) on the other side of the mandible | Device | Group CF |
Primary outcome
Periimplant bone level change
Time frame: up to 36 months
Amount of Periimplant bone level change 36 months after loading.
9 secondary outcomes
Implant survival rate
Time frame: up to 36 months
Prosthetic survival
Time frame: 6, 12, 24 and 36 months
Soft tissue evaluation
Time frame: up to 36 months
Patient satisfaction
Time frame: up to 36 months
Clinician satisfaction
Time frame: up to 36 months
Adverse events
Time frame: up to 36 months
Device deficiences
Time frame: up to 36 months
Implant success rate
Time frame: up to 36 months
Prosthetic success rate
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
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Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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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.
Waleska Caldas, PhD study chair
Neodent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular partial rehabilitation with IF Tapared implants and Mandibular partial rehabilitation with CF Tapared implants in people with Edentulous Jaw, run by Neodent at 1 site in Brazil.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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 Brazil. 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?
Results are not available in the source record.
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?
Periimplant bone level change (time frame: up to 36 months). 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 13 Nov 2023.