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OpenTrials
Completed

NCT Number: NCT04022265

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

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

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colombia

Cartagena, 5710, Colombia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant placement

Device

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

ARDEC Academy

Network

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2019
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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