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

Behavior of the Peri-implant Tissues on the Multiposition Abutment Straight Aesthetic Slim Anti-rotational Galimplant

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 months post-prosthetic loading.

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed; Dental Prosthesis Failure
• Intervention / Treatment: Procedure: Straight abutment; Procedure: Slim abutment

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15785
      • Mario Pérez Sayáns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Group; The control group is considered, using the company's classic multi-position straight anti-rotational abutment	Procedure: Straight abutment; This is the classic abutment, straight and anti-rotational for dental implants which have been tested before
EXPERIMENTAL: Test group; The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used	Procedure: Slim abutment; This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basal Peri-implant tissue level: implant stability	Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. We will load the crowns 8 weeks after implant surgery. Investigators will evaluate the stability at different moments, 8 weeks, 6 months and 12 months. 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. ISQ values are obtained using resonance frequency analysis (RFA).	1 day
Basal Radiological Bone Implant level	At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.	1 day
Basal Peri-implant tissue level: probing depth	At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.	1 day
Radiological bone implant stability	After the implantation, we´ll load the temporary 8 weeks after the implantation. Investigators will evaluate the bone level stability at 6 weeks in both groups, through a dental X-ray radiography. The bone stability will be measured as a difference between de basal bone level and the actual one in mm.	8 weeks
Peri-implant tissue stability: probing depth	After the implantation, we´ll load the definitive prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be given by the differences between both measures, basal and actual in mm.	8 weeks
Peri-implant tissue stability: ISQ	After the implantation, we´ll load the temporary prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be given by the differences between both measures, basal and actual.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term evaluation of definitive prostheses	After 6 months of loading of final ceramic restoration, investigators will evaluate the differences of clinical (mm of probing depth, ISQ implant stability) and radiological aspects (bone implant level in mm calculated from the neck to the actual bone level, comparing on the basal and final values.	6 months

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Galimplant Dental Implants

Publications and helpful links

Helpful Links

• GI-1319

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): January 8, 2020

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: dental implant; periimplant tissues
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: CT-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will anonymize and categorize the clinical and radiological data of the patients to share the information with the other researchers of the group
• IPD Sharing Time Frame: Time Frame:
• IPD Sharing Access Criteria: under request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No