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

Primary Purpose

Dental Implant Failed, Dental Prosthesis Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Straight abutment
Slim abutment
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implant Failed focused on measuring dental implant, periimplant tissues

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Mario Pérez Sayáns

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Test group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.

Full Information

First Posted
January 3, 2019
Last Updated
March 31, 2020
Sponsor
University of Santiago de Compostela
Collaborators
Galimplant Dental Implants
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1. Study Identification

Unique Protocol Identification Number
NCT03796494
Brief Title
Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)
Acronym
(PSG)
Official Title
Behavior of the Peri-implant Tissues on the Multiposition Abutment Straight Aesthetic Slim Anti-rotational Galimplant
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela
Collaborators
Galimplant Dental Implants

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 months post-prosthetic loading.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant Failed, Dental Prosthesis Failure
Keywords
dental implant, periimplant tissues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group is considered, using the company's classic multi-position straight anti-rotational abutment
Arm Title
Test group
Arm Type
Experimental
Arm Description
The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used
Intervention Type
Procedure
Intervention Name(s)
Straight abutment
Intervention Description
This is the classic abutment, straight and anti-rotational for dental implants which have been tested before
Intervention Type
Procedure
Intervention Name(s)
Slim abutment
Intervention Description
This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space
Primary Outcome Measure Information:
Title
Primary stability of implants and peri-implant tissues
Description
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
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Basal Peri-implant tissue level: implant stability
Description
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).
Time Frame
1 day
Title
Basal Radiological Bone Implant level
Description
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.
Time Frame
1 day
Title
Basal Peri-implant tissue level: probing depth
Description
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.
Time Frame
1 day
Title
Radiological bone implant stability
Description
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.
Time Frame
8 weeks
Title
Peri-implant tissue stability: probing depth
Description
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.
Time Frame
8 weeks
Title
Peri-implant tissue stability: ISQ
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Long-term evaluation of definitive prostheses
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mario Pérez Sayáns
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15785
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
http://imaisd.usc.es/grupoficha.asp?idpersoatipogrupo=75189&i=es&s=-2-26-148
Description
GI-1319

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

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