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

NCT07310979 | Enrolling By Invitation

• 1 other identifier: 5957583
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants; Dental Prosthesis, Implant-Supported

Keywords

Abutment design; Dental Implants; Biomechanics

Outcome Measures

Primary Outcomes (1)

• 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)

  baseline vs. 3 months

Secondary Outcomes (11)

• Changes in Marginal Bone Level (mm)

  baseline vs. 12-18 months after prosthetic loading

• Changes in Peri-Implant Probing Depth

  baseline versus 3-4 months (T2) after prosthetic loading

• Changes in Peri-Implant Probing Depth

  baseline versus 12-18 months (T2) after prosthetic loading

• Presence of Bleeding on Probing

  baseline versus 3-4 months (T2) after prosthetic loading

• Presence of Bleeding on Probing

  baseline versus 12-18 months (T2) after prosthetic loading

Interventions

Triple-Abutment System with Hyperbolic Paraboloid Geometry DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais, Dental School

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Study Officials

• Fernando O Costa, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 29, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)