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Completed

NCT Number: NCT03714139

Immediate Loading a Histological Study

Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. One site will be used as a test and one as a control where experimental mini-implants will be installed. Reconstructive surgical procedures will be applied at the biopsy sites.

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Key information

Conditions

Edentulous Alveolar Ridge

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

Objective: - To evaluate histologically the influence of the functional load on implants, both immediate and delayed.

Material and methods: 12 participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments to obtain a high degree of torque to ensure optimum primary stability. At least one site will be used as a test and one as a control where experimental mini-implants will be installed. Test sites will be loaded immediately. The control sites will remain unloaded. After 2 months, mini-implants will be recovered as planned for each group. Reconstructive surgical procedures will be applied at the biopsy sites, if necessary, using autologous bone or bone substitutes and membranes. Standard implants will be installed during the same surgical session and, after 2 months, the planned prosthesis will be performed. Patients will be followed for at least 2 years for evaluation and intervention, if necessary.

Biopsies will be included in resin to obtain wear cuts for histomorphometric analysis. The bone histomorphometry will be evaluated and statistical analysis will be carried out.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included.
  • Natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts

Exclusion criteria

  • untreated rampant caries or uncontrolled periodontal disease of the remaining teeth
  • diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration
  • need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration
  • inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators
  • pregnancy

Treatment and study plan

Immediate loading

Procedure

The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden & Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed.

Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day.

Other names: implant surgery, prosthesis

non implant loading

Procedure

Control implants will receive a healing screw and will remain unloaded

Other names: control site

Primary outcomes

  1. bone to implant contact

    Time frame: 2 months

    The linear distances between IS and B (IS-B) and CM and X (CM-X) were measured parallel to the long axis of the implant at both sides of the implant at a magnification of x100.

    Moreover, the amount of new bone, old bone, total bone (new + old bone = BIC%

Secondary outcomes

  1. Bone density

    Time frame: 2 months

    The total amount of mineralized bone in contact with the implant surface measured histomorphometrically

Sponsors and collaborators

Lead sponsor

ARDEC Academy

Network

Registry information

Official study title

Immediate Loading-A Histological Study in Humans

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 22, 2018
Registry last updated
Oct 5, 2020

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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