Immediate Loading a Histological Study

September 30, 2020 updated by: ARDEC Academy

Immediate Loading-A Histological Study in Humans

Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. One site will be used as a test and one as a control where experimental mini-implants will be installed. Reconstructive surgical procedures will be applied at the biopsy sites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: - To evaluate histologically the influence of the functional load on implants, both immediate and delayed.

Material and methods: 12 participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments to obtain a high degree of torque to ensure optimum primary stability. At least one site will be used as a test and one as a control where experimental mini-implants will be installed. Test sites will be loaded immediately. The control sites will remain unloaded. After 2 months, mini-implants will be recovered as planned for each group. Reconstructive surgical procedures will be applied at the biopsy sites, if necessary, using autologous bone or bone substitutes and membranes. Standard implants will be installed during the same surgical session and, after 2 months, the planned prosthesis will be performed. Patients will be followed for at least 2 years for evaluation and intervention, if necessary.

Biopsies will be included in resin to obtain wear cuts for histomorphometric analysis. The bone histomorphometry will be evaluated and statistical analysis will be carried out.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Cartagena
      • Cartagena de Indias, Cartagena, Colombia, 5710
        • Colombia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included.
  • Natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts

Exclusion Criteria:

  • untreated rampant caries or uncontrolled periodontal disease of the remaining teeth
  • diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration
  • need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration
  • inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate implant Loading
Immediate loading is defined as the placement of the implant and immediate prosthetic restoration
Procedure: immediate loading

The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden & Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed.

Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day.

Other Names:
  • implant surgery, prosthesis
Procedure: non implant loading
Control implants will receive a healing screw and will remain unloaded
Other Names:
  • control site
No Intervention: non implant loading
there is not immediate prosthetic restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone to implant contact
Time Frame: 2 months

The linear distances between IS and B (IS-B) and CM and X (CM-X) were measured parallel to the long axis of the implant at both sides of the implant at a magnification of x100.

Moreover, the amount of new bone, old bone, total bone (new + old bone = BIC%
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density
Time Frame: 2 months
The total amount of mineralized bone in contact with the implant surface measured histomorphometrically
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARDEC Academy

Investigators

  • Study Director: Daniele Botticelli, PHd, ARDEC Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dental implants

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

there is a plan to save all the data to do the follow up

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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