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OpenTrials
Completed

NCT Number: NCT04017156

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

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

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colombia

Cartagena, 5710, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

implant installation

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

ARDEC Academy

Network

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 12, 2019
Registry last updated
Jul 12, 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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