Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.

NCT ID: NCT05284461

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-09-01

Brief Summary

The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.

Conditions

Edentulous; Alveolar Process, Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mechanized parallel abutments

Implants were immediately covered with this type of abutments after insertion. This is the most common procedure. It would be the gold standard

Group Type: PLACEBO_COMPARATOR

dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

Intervention Type: DEVICE

Dental implants with transepithelial abutments with distinct morphology

Anodized parallel abutments

Implants were immediately covered with this kind of abutments after insertion. Only the surface treatment varies to the gold standard

Group Type: EXPERIMENTAL

dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

Intervention Type: DEVICE

Dental implants with transepithelial abutments with distinct morphology

Mechanized convergent abutments

Implants were immediately covered with this kind of abutments after insertion. Only the geometry of the emergence profile varies with regards to the gold standard

Group Type: EXPERIMENTAL

dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

Intervention Type: DEVICE

Dental implants with transepithelial abutments with distinct morphology

Anodized convergent abutments

Implants were immediately covered with this kind of abutments after insertion. Both the surface treatment and the geometry vary with regards to the gold standard

Group Type: EXPERIMENTAL

dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

Intervention Type: DEVICE

Dental implants with transepithelial abutments with distinct morphology

Interventions

dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

Dental implants with transepithelial abutments with distinct morphology

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders

Exclusion Criteria

• evidence of systemic or psychic pathology that contraindicates implant treatment.

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

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

JAVIER MONTERO

Professor in Prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica Odontológica de la Universidad de Salamanca

Salamanca, , Spain

Countries

Spain

Other Identifiers

USAL_2021_JMONT

Identifier Type: -

Identifier Source: org_study_id