Peri-implant Tissues in BLX® Implants (BLX)

Behavior of Peri-implant Tissues in BLX® Implants Placed on Mature Scarred Bone

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed; Dental Prosthesis Failure
• Intervention / Treatment: Procedure: Implant bed preparation protocol; Procedure: Implant loading

• Study Type: Interventional
• Enrollment (Actual): 40
• 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full preparation; Group A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed.	Procedure: Implant bed preparation protocol; This is the first surgical phase, we prepare the implant bed by using different increasing size drills.; Other Names: IBP
Experimental: Partial preparation; Group B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out.	Procedure: Implant bed preparation protocol; This is the first surgical phase, we prepare the implant bed by using different increasing size drills.; Other Names: IBP
Experimental: Deferred loading; 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.	Procedure: Implant loading; This is the second phase, based on prosthetic procedures, to design the crown over the dental implant; Other Names: IL
Experimental: Immediate 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.	Procedure: Implant loading; This is the second phase, based on prosthetic procedures, to design the crown over the dental implant; Other Names: IL

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 (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	12 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 (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).	1 day
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.	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. We 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 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.	6 weeks
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.	6 weeks
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.	6 weeks
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.	6 months
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.	6 months
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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term evaluation of definitive prostheses	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.	12 months

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Manohay Dental SAU
• Investigators: Principal Investigator: Mario Perez Sayans, PhD, University of Santiago de Compostela

Publications and helpful links

Helpful Links

• GI-1319

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): June 19, 2020

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: dental implant; immediate loading; periimplant tissues
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: CT-2018-05

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 (n=9)
• IPD Sharing Time Frame: From the beginning to sex month after finishing the study
• IPD Sharing Access Criteria: Under request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• 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