Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)

University of Santiago de Compostela

Status: Completed

Conditions: Dental Implant Failed; Dental Prosthesis Failure

Treatments: Procedure: Straight abutment; Procedure: Slim abutment

Study type: Interventional

Funder types: Other

Identifiers

NCT03796494

CT-2019-01

Details and patient eligibility

About

This is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12-24 months post-prosthetic loading.

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients without systemic pathology that are grounds for absolute contraindication
• Older adults who agree to be part of the study and sign the informed consent
• Consumption of tobacco less than 5 cigarettes / day
• Do not be completely toothless
• Absences of at least two pieces in posterior area with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques. In case of odd absences (3,5,7), a Slim pillar will be placed, being the group to always be the majority.
• Area of mature bone healed at least 6 months post-extraction.
• Patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm long

Exclusion criteria

• Immunosuppressed
• Aesthetic edentulous areas of 13-23 and 33-43
• Smokers of more than 5 cigarettes
• Index of bleeding greater than 30%
• Patients with less than 2 mm of keratinized gingiva
• Implants with primary stability with ISQ <55
• Implants with ISQ index <55 at 8 weeks
• When a margin of safety can not be assumed to the inferior dental nerve of at least 1 mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Control Group

Active Comparator group

Description:

The control group is considered, using the company's classic multi-position straight anti-rotational abutment

Treatment:

Procedure: Straight abutment

Test group

Experimental group

Description:

The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used

Treatment:

Procedure: Slim abutment