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

Sponsor
ARDEC Academy (Other)
Overall Status
Completed
CT.gov ID
NCT04017156
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
14.9
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: implant installation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Clinical TrialClinical Trial
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The two recipient sites will be selected prior the surgery, while the type of site preparation will be randomly decided. The randomization will be performed electronically (randomization.com) by a researcher neither involved in the selection of the patients nor in installation of the devices (DB). Sealed opaque envelopes will be prepared and opened at the time of surgery by an author not involved in the surgery (DB). Surgeon and patients will be blinded.
Primary Purpose:
Treatment
Official Title:
Bone Healing at Non-submerged Implants Installed With Different Insertion Torques. A Split Mouth Histomorphometric Randomized Controlled Trial.
Actual Study Start Date :
Jul 20, 2016
Actual Primary Completion Date :
Nov 22, 2016
Actual Study Completion Date :
Oct 17, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. New bone in contact with the implant surface [After 8 weeks of healing]

      The percentages of new bone will be evaluated both in contact with the implant surface

    Secondary Outcome Measures

    1. Bone density around the implant surface [After 8 weeks of healing]

      The total mineralized bone will be assessed as sum of new and old bone

    Other Outcome Measures

    1. pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colombia Cartagena de Indias Cartagena Colombia 5710

    Sponsors and Collaborators

    • ARDEC Academy

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    ARDEC Academy
    ClinicalTrials.gov Identifier:
    NCT04017156
    Other Study ID Numbers:
    • protocol #04-2014
    First Posted:
    Jul 12, 2019
    Last Update Posted:
    Jul 12, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrophy

    Study Results

    No Results Posted as of Jul 12, 2019