Clinical Evaluation of a Hyperbolic Paraboloid Triple-Abutment on Morse Taper Dental Implants

NCT ID: NCT07310979

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-29
• Study Completion Date: 2028-12-29

Brief 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. 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.

Conditions

Dental Implants; Dental Prosthesis, Implant-Supported

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Triple-Abutment System with Hyperbolic Paraboloid Geometry

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• diabetes mellitus (any type) or uncontrolled systemic disease.
• current or recent tobacco/nicotine use
• bisphosphonates or other antiresorptives,
• immunosuppressive therapy,
• osteoporosis
• pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Fernando O Costa

Titular professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando O Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Federal University of Minas Gerais, Dental School

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

5957583

Identifier Type: -

Identifier Source: org_study_id