Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills

July 17, 2019 updated by: ARDEC Academy

Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial

The purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixteen volunteer patients will be recruited. Two titanium mini-implants will be installed in the distal segments of the maxilla in recipient sites prepared with either a sonic device or conventional drills. Biopsies containing the mini-implants will be retrieved after 2 weeks in eight patients, and after 6 weeks in the other eight patients. Histomorphometric analyses will be performed

Study Type

Interventional

Enrollment (Actual)

16

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of an edentulous atrophic zone in the posterior segment of the maxilla
  • height of the sinus floor ≥10 mm
  • ≥ 25 years of age;
  • smoking ≤10 cigarettes per day
  • good general health
  • no contraindication for oral surgical procedures
  • not being pregnant.

Exclusion Criteria:

  • presence of systemic disorders
  • chemotherapy or radiotherapy
  • smokers >10 cigarettes per day
  • previous bone augmentation procedures in the same region.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control Site -Drill site
The control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm,
Device: implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Other Names:
  • implant surgery, prosthesis
EXPERIMENTAL: Test site -sonic site
test sites will be prepared with conical diamond inserts of increasing diameter (SFS99.000.014 to SFS99.000.024, Komet-Brasseler-GmbH, Germany) mounted on a sonic-air surgical instrument
Device: implant placement
Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Other Names:
  • implant surgery, prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New bone in contact with the implant surface
Time Frame: After 2 weeks to evaluate the healing prior to load with a prosthesis
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
After 2 weeks to evaluate the healing prior to load with a prosthesis
New bone in contact with the implant surface
Time Frame: After 6 weeks, to evaluate the healing prior to load with a prosthesis
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
After 6 weeks, to evaluate the healing prior to load with a prosthesis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of total mineralized bone in contact with the implant surface.
Time Frame: After 2 weeks to evaluate the healing prior to load with a prosthesis
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
After 2 weeks to evaluate the healing prior to load with a prosthesis
The percentage of total mineralized bone in contact with the implant surface.
Time Frame: After 6 weeks to evaluate the healing prior to load with a prosthesis
The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis
After 6 weeks to evaluate the healing prior to load with a prosthesis

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels
Time Frame: After 2 weeks to evaluate the early haling prior to load with a prosthesis
The percentages of pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants and vessels in contact with the implant surface will be evaluated in the histomorphometric analysis.
After 2 weeks to evaluate the early haling prior to load with a prosthesis
pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels
Time Frame: After 6 weeks to evaluate the early haling prior to load with a prosthesis
The percentages of pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants and vessels in contact with the implant surface will be evaluated in the histomorphometric analysis.
After 6 weeks to evaluate the early haling prior to load with a prosthesis

Collaborators and Investigators

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

Sponsor

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)

February 4, 2016

Primary Completion (ACTUAL)

August 30, 2017

Study Completion (ACTUAL)

December 15, 2017

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 13, 2019

First Posted (ACTUAL)

July 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol #05-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will be shared after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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