NCT03720236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

November 2, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

October 5, 2018

Last Update Submit

July 2, 2020

Conditions

Dental Implant FailedDental Prosthesis Failure

Keywords

dental implantimmediate loadingperiimplant 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 (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 Outcomes (9)

  • 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

    6 weeks

  • Peri-implant tissue stability: probing depth

    6 weeks

  • +4 more secondary outcomes

Other Outcomes (1)

  • Long-term evaluation of definitive prostheses

    12 months

Study Arms (4)

Full preparation

EXPERIMENTAL

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

Partial preparation

EXPERIMENTAL

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

Deferred loading

EXPERIMENTAL

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

Immediate load

EXPERIMENTAL

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

Interventions

Implant bed preparation protocolPROCEDURE

This is the first surgical phase, we prepare the implant bed by using different increasing size drills.

Also known as: IBP
Full preparationPartial preparation
Implant loadingPROCEDURE

This is the second phase, based on prosthetic procedures, to design the crown over the dental implant

Also known as: IL
Deferred loadingImmediate load

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mario Pérez Sayáns

Santiago de Compostela, A Coruña, 15785, Spain

Location

Related Links

MeSH Terms

Interventions

O,O-diisopropyl-S-benzylthiophosphateImmediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Officials

  • Mario Perez Sayans, PhD

    University of Santiago de Compostela

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 25, 2018

Study Start

November 2, 2018

Primary Completion

January 10, 2019

Study Completion

June 19, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
From the beginning to sex month after finishing the study
Access Criteria
Under request

Locations

ES(1)