Bone Healing at Non-submerged Implants Installed With Different Insertion Torques.

July 11, 2019 updated by: ARDEC Academy

Bone Healing at Non-submerged Implants Installed With Different Insertion Torques. A Split Mouth Histomorphometric Randomized Controlled Trial.

The objective of the study is to evaluate histomorphometrically the healing at implants installed with standard or very low insertion torque values.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Very high insertion torque values have been recommended when immediate loading is applied to implants.1 However, it has been shown that similar clinical outcomes may be achieved even with insertion torque values ≤15 Ncm when implants are splinted together. Due to the contradictory outcomes on the influence of the torque on osseointegration and a lack of histological data in humans, there is a need of more evidences that may support the clinicians in the decision making when an unintentional low insertion torque occur at implants during the daily practice. So the aim of the study i evaluate histomorphometrically the healing at implants installed in Twelve volunteer patients that will be recruited. Two screw-shaped titanium devices will be installed in the distal segments of the mandible using insertion torque values of either <10 Ncm or ~30 Ncm. The implants were left to heal in a non-submerged fashion. After 8 weeks, biopsies will be retrieved and ground sections will be prepared for histological evaluation.

Study Type

Interventional

Enrollment (Actual)

24

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of at least two edentulous zone in the posterior segment of the mandible
  • ≥ 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 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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test site (torque of <10 Ncm)
The test sites (<10 Ncm) will be over-prepared with drills of larger diameter
Procedure: implant installation
All site preparations will be performed deeper compared to the length of the implant so that the implant apex cannot reach the bottom of the osteotomy.
Other Names:
  • implant surgery
Other: Control site (torque of ~30 Ncm)
the standard sites (~30 Ncm)will be prepared with the corresponding drills suggested by the manufacturer
Procedure: implant installation
All site preparations will be performed deeper compared to the length of the implant so that the implant apex cannot reach the bottom of the osteotomy.
Other Names:
  • implant surgery

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 8 weeks of healing
The percentages of new bone will be evaluated both in contact with the implant surface
After 8 weeks of healing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density around the implant surface
Time Frame: After 8 weeks of healing
The total mineralized bone will be assessed as sum of new and old bone
After 8 weeks of healing

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue)
Time Frame: After 8 weeks of healing
The percentages of pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue) will be evaluated all in contact with the implant surface
After 8 weeks of healing

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)

July 20, 2016

Primary Completion (Actual)

November 22, 2016

Study Completion (Actual)

October 17, 2017

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol #04-2014

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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