Dental ImplantsNCT07310979
Clinical Evaluation of a Hyperbolic Paraboloid Triple-Abutment on Morse Taper Dental Implants
An observational study of Dental Implants and Dental Prosthesis, Implant-Supported, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a novel triple-abutment system with hyperbolic paraboloid geometry installed on Morse taper dental implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Dental Prosthesis, Implant-Supported
- What is being tested?
- Triple-Abutment System with Hyperbolic Paraboloid Geometry
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Dec 2025to 29 Dec 2028
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample will be composed of adult patients with three adjacent missing teeth who underwent placement of a Morse taper dental implant, followed by a healing period of approximately three months for osseointegration. After confirmation of osseointegration, participants will be eligible for fixed implant-supported rehabilitation using a triple-abutment system designed to support a three-unit prosthesis on a single implant, according to clinical planning.
Who may be able to join
- Adults aged ≥ 18 years.
- Systemically healthy as determined by medical history and clinical assessment.
- Non-smokers (no tobacco use).
- Able and willing to comply with study visits and maintenance program, and provide written informed consent.
Who cannot join
- diabetes mellitus (any type) or uncontrolled systemic disease.
- current or recent tobacco/nicotine use
- bisphosphonates or other antiresorptives,
- immunosuppressive therapy,
- osteoporosis
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Federal University of Minas Gerais, Dental School
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Biomechanical and Clinical Effects of a Hyperbolic Paraboloid Triple-Abutment System on Morse Taper Dental Implants: Prospective Clinical Study With Finite Element Corroboration
This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a novel triple-abutment system with hyperbolic paraboloid geometry installed on Morse taper dental implants. The system is designed to support three adjacent crowns on a single implant, aiming to optimize load distribution and preserve peri-implant tissue stability.
Thirty systemically healthy adults missing three adjacent teeth will undergo implant placement, followed by a healing period of approximately three months for osseointegration prior to prosthetic loading. Metal-ceramic restorations will then be cemented over triple abutments. Clinical and radiographic evaluations will be performed at T1 (3-4 months after prosthetic loading) and T2 (12-18 months after prosthetic loading).
The primary outcome will be marginal bone level change assessed by standardized periapical radiographs. Secondary outcomes include probing depth, bleeding on probing, plaque index, keratinized mucosa height, and patient-reported satisfaction. The study aims to investigate whether this innovative abutment design provides stable peri-implant conditions and favorable clinical performance when applied to Morse taper implants.
Read the detailed description
This prospective clinical study aims to evaluate the clinical and radiographic performance of an innovative triple-abutment (TA) system with hyperbolic paraboloid geometry installed on Morse taper dental implants. The abutment system is designed to support three adjacent crowns on a single implant through a fully curved, passive, non-welded configuration, with the objective of optimizing biomechanical load distribution and preserving peri-implant tissue stability. The concept is based on principles of mechanobiology, mechanotransduction, and biotensegrity, integrated within the framework of Optimized Biodynamic Peri-Implant Tissue (BOPiT).
Thirty systemically healthy adult participants presenting with three adjacent missing teeth will be enrolled. Implant placement will be performed following conventional surgical protocols. After surgery, a healing period of approximately three months will be allowed to achieve osseointegration prior to prosthetic loading. Subsequently, metal-ceramic fixed prostheses will be cemented over triple-abutment components. All surgical and prosthetic procedures will be conducted by a single experienced operator to ensure standardization.
Clinical and radiographic evaluations will be performed at two predefined follow-up timepoints: T1, corresponding to 3-4 months after prosthetic loading, and T2, corresponding to 12-18 months after prosthetic loading. The primary outcome measure will be marginal bone level change, assessed on standardized periapical radiographs obtained using the parallel technique with controlled calibration, and measured at the mesial and distal aspects of each implant.
Secondary outcome measures will include probing depth, bleeding on probing, plaque index, keratinized mucosa height, and patient-reported satisfaction assessed using a visual analog scale (VAS). Clinical maintenance visits will be scheduled every four months between T1 and T2 to monitor peri-implant health and prosthetic performance.
Statistical analyses will be conducted using parametric methods appropriate for repeated measures, with strategies to account for potential within-subject correlation in participants receiving more than one implant. Adverse events and biological or prosthetic complications will be recorded throughout the study period. The risks associated with participation are minimal and comparable to those of conventional implant-supported rehabilitations. In the event of complications, the triple-abutment system may be replaced by conventional abutments according to clinical judgment.
This study seeks to provide clinical evidence regarding the biomechanical and biological behavior of the triple-abutment system when applied to Morse taper implants, potentially supporting a more conservative and cost-effective rehabilitative approach by enabling the restoration of three adjacent teeth with a single implant while maintaining peri-implant tissue stability.
- Being tested
- Triple-Abutment System with Hyperbolic Paraboloid Geometry
- Keywords
- Abutment design, Dental Implants, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple-Abutment System with Hyperbolic Paraboloid GeometryDevice
Prosthetic loading will be performed on osseointegrated morse taper dental implants using a fixed implant-supported rehabilitation with a triple-abutment system featuring hyperbolic paraboloid geometry. Metal-ceramic prostheses will be cemented over the abutment components. All procedures will be performed by a single operator.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Marginal Bone Level (mm)
Marginal bone level measured in millimeters at the mesial and distal aspects of each implant using standardized periapical radiographs with the parallel technique and calibrated measurements, assessed at T1 (3-4 months)
Measured: baseline vs. 3 months
Secondary outcomes (11)
Changes in Marginal Bone Level (mm)
Marginal bone level measured in millimeters at the mesial and distal aspects of each implant using standardized periapical radiographs, assessed to evaluate medium-term peri-implant bone stability (12-18 months).
Measured: baseline vs. 12-18 months after prosthetic loading
Changes in Peri-Implant Probing Depth
Probing depth measured in millimeters at six sites per implant using a standardized periodontal probe.
Measured: baseline versus 3-4 months (T2) after prosthetic loading
Changes in Peri-Implant Probing Depth
Probing depth measured in millimeters at six sites per implant using a standardized periodontal probe.
Measured: baseline versus 12-18 months (T2) after prosthetic loading
Presence of Bleeding on Probing
Presence or absence of bleeding on probing assessed at six peri-implant sites per implant and expressed as the percentage of sites with bleeding.
Measured: baseline versus 3-4 months (T2) after prosthetic loading
Presence of Bleeding on Probing
Presence or absence of bleeding on probing assessed at six peri-implant sites per implant and expressed as the percentage of sites with bleeding.
Measured: baseline versus 12-18 months (T2) after prosthetic loading
Presence of dental plaque
Presence of dental plaque assessed at peri-implant sites and expressed as the percentage of sites with visible plaque.
Measured: baseline versus 3-4 months (T2) after prosthetic loading
Presence of dental plaque
Presence of dental plaque assessed at peri-implant sites and expressed as the percentage of sites with visible plaque.
Measured: baseline versus 12-18 months (T2) after prosthetic loading
Changes in Keratinized Mucosa Height
Width of keratinized peri-implant mucosa measured in millimeters at the mid-buccal aspect of each implant.
Measured: baseline versus 3-4 months (T2) after prosthetic loading
Changes in Keratinized Mucosa Height
Width of keratinized peri-implant mucosa measured in millimeters at the mid-buccal aspect of each implant.
Measured: baseline versus 12-18 months (T2) after prosthetic loading
Level of Patient Satisfaction
Patient-reported satisfaction with the implant-supported prosthetic rehabilitation assessed using a visual analog (VAS) scale. VAS ranging from 0 to 10; 10 indicates a complete satisfaction score.
Measured: baseline versus 3-4 months (T2) after prosthetic loading
Level of Patient Satisfaction
Patient-reported satisfaction with the implant-supported prosthetic rehabilitation assessed using a visual analog (VAS) scale. VAS ranging from 0 to 10; 10 indicates a complete satisfaction score.
Measured: baseline versus 12-18 months (T2) after prosthetic loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start29 Dec 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando O Costa, Federal University of Minas Gerais
- Investigators
- Fernando O Costa, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310979
- Sponsor's protocol ID
- 5957583
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical and Clinical Effects of a Hyperbolic Paraboloid Triple-Abutment System on Morse Taper Dental Implants: Prospective Clinical Study With Finite Element Corroboration
- ClinicalTrials.gov ID
- NCT07310979
- Acronym / sponsor ID
- 5957583
- Keywords
- Abutment design, Dental Implants, Biomechanics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 30 Dec 2025 (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.
This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a novel triple-abutment system with hyperbolic paraboloid geometry installed on Morse taper dental implants. The system is designed to support three adjacent crowns on a single implant, aiming to optimize load distribution and preserve peri-implant tissue stability.
Thirty systemically healthy adults missing three adjacent teeth will undergo implant placement, followed by a healing period of approximately three months for osseointegration prior to prosthetic loading. Metal-ceramic restorations will then be cemented over triple abutments. Clinical and radiographic evaluations will be performed at T1 (3-4 months after prosthetic loading) and T2 (12-18 months after prosthetic loading).
The primary outcome will be marginal bone level change assessed by standardized periapical radiographs. Secondary outcomes include probing depth, bleeding on probing, plaque index, keratinized mucosa height, and patient-reported satisfaction. The study aims to investigate whether this innovative abutment design provides stable peri-implant conditions and favorable clinical performance when applied to Morse taper implants.
Detailed description
This prospective clinical study aims to evaluate the clinical and radiographic performance of an innovative triple-abutment (TA) system with hyperbolic paraboloid geometry installed on Morse taper dental implants. The abutment system is designed to support three adjacent crowns on a single implant through a fully curved, passive, non-welded configuration, with the objective of optimizing biomechanical load distribution and preserving peri-implant tissue stability. The concept is based on principles of mechanobiology, mechanotransduction, and biotensegrity, integrated within the framework of Optimized Biodynamic Peri-Implant Tissue (BOPiT).
Thirty systemically healthy adult participants presenting with three adjacent missing teeth will be enrolled. Implant placement will be performed following conventional surgical protocols. After surgery, a healing period of approximately three months will be allowed to achieve osseointegration prior to prosthetic loading. Subsequently, metal-ceramic fixed prostheses will be cemented over triple-abutment components. All surgical and prosthetic procedures will be conducted by a single experienced operator to ensure standardization.
Clinical and radiographic evaluations will be performed at two predefined follow-up timepoints: T1, corresponding to 3-4 months after prosthetic loading, and T2, corresponding to 12-18 months after prosthetic loading. The primary outcome measure will be marginal bone level change, assessed on standardized periapical radiographs obtained using the parallel technique with controlled calibration, and measured at the mesial and distal aspects of each implant.
Secondary outcome measures will include probing depth, bleeding on probing, plaque index, keratinized mucosa height, and patient-reported satisfaction assessed using a visual analog scale (VAS). Clinical maintenance visits will be scheduled every four months between T1 and T2 to monitor peri-implant health and prosthetic performance.
Statistical analyses will be conducted using parametric methods appropriate for repeated measures, with strategies to account for potential within-subject correlation in participants receiving more than one implant. Adverse events and biological or prosthetic complications will be recorded throughout the study period. The risks associated with participation are minimal and comparable to those of conventional implant-supported rehabilitations. In the event of complications, the triple-abutment system may be replaced by conventional abutments according to clinical judgment.
This study seeks to provide clinical evidence regarding the biomechanical and biological behavior of the triple-abutment system when applied to Morse taper implants, potentially supporting a more conservative and cost-effective rehabilitative approach by enabling the restoration of three adjacent teeth with a single implant while maintaining peri-implant tissue stability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample will be composed of adult patients with three adjacent missing teeth who underwent placement of a Morse taper dental implant, followed by a healing period of approximately three months for osseointegration. After confirmation of osseointegration, participants will be eligible for fixed implant-supported rehabilitation using a triple-abutment system designed to support a three-unit prosthesis on a single implant, according to clinical planning.
Key inclusion criteria (4 listed)
- Adults aged ≥ 18 years.
- Systemically healthy as determined by medical history and clinical assessment.
- Non-smokers (no tobacco use).
- Able and willing to comply with study visits and maintenance program, and provide written informed consent.
Key exclusion criteria (6 listed)
- diabetes mellitus (any type) or uncontrolled systemic disease.
- current or recent tobacco/nicotine use
- bisphosphonates or other antiresorptives,
- immunosuppressive therapy,
- osteoporosis
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 |
|---|---|---|
| Triple-Abutment System with Hyperbolic Paraboloid GeometryProsthetic loading will be performed on osseointegrated morse taper dental implants using a fixed implant-supported rehabilitation with a triple-abutment system featuring hyperbolic paraboloid geometry. Metal-ceramic prostheses will be cemented over the abutment components. All procedures will be performed by a single operator. | Device | – |
Primary outcome
Changes in Marginal Bone Level (mm)
Time frame: baseline vs. 3 months
Marginal bone level measured in millimeters at the mesial and distal aspects of each implant using standardized periapical radiographs with the parallel technique and calibrated measurements, assessed at T1 (3-4 months)
11 secondary outcomes
Changes in Marginal Bone Level (mm)
Time frame: baseline vs. 12-18 months after prosthetic loading
Changes in Peri-Implant Probing Depth
Time frame: baseline versus 3-4 months (T2) after prosthetic loading
Changes in Peri-Implant Probing Depth
Time frame: baseline versus 12-18 months (T2) after prosthetic loading
Presence of Bleeding on Probing
Time frame: baseline versus 3-4 months (T2) after prosthetic loading
Presence of Bleeding on Probing
Time frame: baseline versus 12-18 months (T2) after prosthetic loading
Presence of dental plaque
Time frame: baseline versus 3-4 months (T2) after prosthetic loading
Presence of dental plaque
Time frame: baseline versus 12-18 months (T2) after prosthetic loading
Changes in Keratinized Mucosa Height
Time frame: baseline versus 3-4 months (T2) after prosthetic loading
Changes in Keratinized Mucosa Height
Time frame: baseline versus 12-18 months (T2) after prosthetic loading
Level of Patient Satisfaction
Time frame: baseline versus 3-4 months (T2) after prosthetic loading
Level of Patient Satisfaction
Time frame: baseline versus 12-18 months (T2) after prosthetic loading
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 2 Jan 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Fernando O Costa, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants and Dental Prosthesis, Implant-Supported, run by Federal University of Minas Gerais 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 4 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: enrolling by invitation, as of the sponsor's last update on 2 Jan 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 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?
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?
Changes in Marginal Bone Level (mm) (time frame: baseline vs. 3 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 2 Jan 2026.