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Peri-implant Tissues in BLX® Implants (BLX)

Primary Purpose

Dental Implant Failed, Dental Prosthesis Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Implant bed preparation protocol
Implant loading
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, immediate loading, periimplant tissues

Eligibility Criteria

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

Inclusion Criteria:

  • Patients without systemic pathology
  • Adult of age who agree to be part of the study and sign the informed consent.
  • Patients smoking less than 5 cigarettes / day,
  • Patients not being completely edentulous
  • Unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques
  • Area of mature bone healed at least 6 months post-extraction.
  • The minimum torque for early loading will be 25 N. The placement of the implant will be mechanical up to 40 N maximum and manually finished with a surgical dynamometer.
  • The placement of the abutment will be at a minimum of 25 N, in case the primary stability of the implant allows it, it will be placed at 35 N.
  • The placement of the implant must always be 4 mm below the future gingival margi

Exclusion Criteria:

  • Immunosuppressed patients
  • Aesthetic edentulous areas of 13-23 and 33-43
  • Smokers of more than 5 cigarettes
  • Implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study.
  • Index of bleeding greater than 30%
  • Patients with less than 2 mm of keratinized gingiva
  • Implants with ISQ index <55
  • When a margin of 1 mm safety cannot be assumed to the inferior dental nerve

Sites / Locations

  • Mario Pérez Sayáns

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Full preparation

Partial preparation

Deferred loading

Immediate load

Arm Description

Group A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed.

Group B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out.

Code 2: for implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. Impressions will be taken at 6 weeks to place the provisional prosthesis at 8 weeks. At 6 months the final impressions will be taken for the definitive load.

The code 1: to the implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. The impression will be made in the same surgery and the placement of the provisional prosthesis before 7 days. At 6 months the final impressions will be taken for the definitive load.

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 (n = 20) and with the preparation protocol with under-fresh (n = 20). We 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 (n = 20) and with the preparation protocol with under-fresh (n = 20). We will load the crowns in two different groups, code 1: loading the implants before 7 days after surgery; code 2: before 8 weeks after implant surgery. We 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 a periapical radiography will be performed, considering this measure the basal radiological bone level (distance from the neck of the implant to the most crestal level of the alveolar bone). We 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. We will calculate the difference between the basal measure and the future measurements.
Radiological bone implant stability
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the bone level stability at 6 weeks in both groups. 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 temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We 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 gave 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 two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be gave by the differences between both measures, basal and actual.
Clinical tissue levels of definitive prostheses: probing depth
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the clinical probing depth, comparing with previous measurements.
Clinical tissue levels of definitive prostheses: ISQ
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the implant stability through RFA, comparing with previous measurements.
Radiological tissue levels of definitive prostheses: bone implant level
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the bone implant level by measuring the distance from de implant neck to the most apical inserted bone, comparing simultaneously with previous measurements.

Full Information

First Posted
October 5, 2018
Last Updated
July 2, 2020
Sponsor
University of Santiago de Compostela
Collaborators
Manohay Dental SAU
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1. Study Identification

Unique Protocol Identification Number
NCT03720236
Brief Title
Peri-implant Tissues in BLX® Implants
Acronym
BLX
Official Title
Behavior of Peri-implant Tissues in BLX® Implants Placed on Mature Scarred Bone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
June 19, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. To this end, 40 BLX implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. They will be divided into 2 study groups, and these in turn into two subgroups. Group A: complete milling, Group B: partial milling. Each group will be assigned with code 1: early load and code 2: deferred load. Clinical and radiological parameters will be evaluated.

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, immediate loading, periimplant tissues

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Full preparation
Arm Type
Experimental
Arm Description
Group A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed.
Arm Title
Partial preparation
Arm Type
Experimental
Arm Description
Group B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out.
Arm Title
Deferred loading
Arm Type
Experimental
Arm Description
Code 2: for implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. Impressions will be taken at 6 weeks to place the provisional prosthesis at 8 weeks. At 6 months the final impressions will be taken for the definitive load.
Arm Title
Immediate load
Arm Type
Experimental
Arm Description
The code 1: to the implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. The impression will be made in the same surgery and the placement of the provisional prosthesis before 7 days. At 6 months the final impressions will be taken for the definitive load.
Intervention Type
Procedure
Intervention Name(s)
Implant bed preparation protocol
Other Intervention Name(s)
IBP
Intervention Description
This is the first surgical phase, we prepare the implant bed by using different increasing size drills.
Intervention Type
Procedure
Intervention Name(s)
Implant loading
Other Intervention Name(s)
IL
Intervention Description
This is the second phase, based on prosthetic procedures, to design the crown over the dental implant
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 (n = 20) and with the preparation protocol with under-fresh (n = 20). We 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
12 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 (n = 20) and with the preparation protocol with under-fresh (n = 20). We will load the crowns in two different groups, code 1: loading the implants before 7 days after surgery; code 2: before 8 weeks after implant surgery. We 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 a periapical radiography will be performed, considering this measure the basal radiological bone level (distance from the neck of the implant to the most crestal level of the alveolar bone). We 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. We 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 prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the bone level stability at 6 weeks in both groups. The bone stability will be measured as a difference between de basal bone level and the actual one in mm.
Time Frame
6 weeks
Title
Peri-implant tissue stability: probing depth
Description
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We 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 gave by the differences between both measures, basal and actual in mm.
Time Frame
6 weeks
Title
Peri-implant tissue stability: ISQ
Description
After the implantation, we´ll load the temporary prostheses in two different moments, 7 days or 8 weeks depending of the aleatory coding. We will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be gave by the differences between both measures, basal and actual.
Time Frame
6 weeks
Title
Clinical tissue levels of definitive prostheses: probing depth
Description
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the clinical probing depth, comparing with previous measurements.
Time Frame
6 months
Title
Clinical tissue levels of definitive prostheses: ISQ
Description
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the implant stability through RFA, comparing with previous measurements.
Time Frame
6 months
Title
Radiological tissue levels of definitive prostheses: bone implant level
Description
The final or definitive prostheses will be inserted in all groups at 6 months. At this time, we will measure the bone implant level by measuring the distance from de implant neck to the most apical inserted bone, comparing simultaneously with previous measurements.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Long-term evaluation of definitive prostheses
Description
After 6 months of loading of final ceramic restoration, we 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, the intermediate, and final values.
Time Frame
12 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 Adult of age who agree to be part of the study and sign the informed consent. Patients smoking less than 5 cigarettes / day, Patients not being completely edentulous Unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques Area of mature bone healed at least 6 months post-extraction. The minimum torque for early loading will be 25 N. The placement of the implant will be mechanical up to 40 N maximum and manually finished with a surgical dynamometer. The placement of the abutment will be at a minimum of 25 N, in case the primary stability of the implant allows it, it will be placed at 35 N. The placement of the implant must always be 4 mm below the future gingival margi Exclusion Criteria: Immunosuppressed patients Aesthetic edentulous areas of 13-23 and 33-43 Smokers of more than 5 cigarettes Implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study. Index of bleeding greater than 30% Patients with less than 2 mm of keratinized gingiva Implants with ISQ index <55 When a margin of 1 mm safety cannot be assumed to the inferior dental nerve
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Perez Sayans, PhD
Organizational Affiliation
University of Santiago de Compostela
Official's Role
Principal Investigator
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 (n=9)
IPD Sharing Time Frame
From the beginning to sex month after finishing the study
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 in BLX® Implants

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