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

NCT03796494 | Completed DMC

• 1 other identifier: CT-2019-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant Failed; Dental Prosthesis Failure

Keywords

dental implant; periimplant tissues

Outcome Measures

Primary Outcomes (1)

• Primary stability of implants and peri-implant tissues

  Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. Investigators will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ

  10 months

Secondary Outcomes (6)

• Basal Peri-implant tissue level: implant stability

  1 day

• Basal Radiological Bone Implant level

  1 day

• Basal Peri-implant tissue level: probing depth

  1 day

• Radiological bone implant stability

  8 weeks

• Peri-implant tissue stability: probing depth

  8 weeks

Other Outcomes (6)

• 6-months clinical evaluation of probing depth

  6 months

• 6-months ISQ evaluation

  6 months

• 6-months radiological evaluation of definitive prostheses

  6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Procedure: Straight abutment

Test group

EXPERIMENTAL

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

Procedure: Slim abutment

Interventions

Straight abutment PROCEDURE

This is the classic abutment, straight and anti-rotational for dental implants which have been tested before

Control Group

Slim abutment PROCEDURE

This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space

Test group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Galimplant Dental Implants: collaborator

Study Sites (1)

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, 15785, Spain

Location

Related Links

• GI-1319

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Mario Perez Sayans MD, PhD (Principal investigator)

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 8, 2019
• Study Start: March 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: January 8, 2020
• Last Updated: December 2, 2024

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Time Frame:
• Access Criteria: under request

Locations

ES (1)