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Evaluation of Bone Quality and Primary and Secondary Stability of Implants Installed in Alveolar Regeneration Area by Three Different Techniques

NCT03973190 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-06-04

No results posted yet for this study

Summary

The objective of this randomized controlled clinical study was to compare bone quality between three different alveolar ridge preservation methods, also with the evaluation of primary and secondary dental implant stabilities at these sites.

Conditions

  • Alveolar Osseous Loss

Interventions

PROCEDURE

Immediate alveolar regeneration after exodontia

The extractions will be performed under local anesthesia, without making a mucoperiosteal flap, making an intraassucular incision and using appropriate periotomes, elevators and forcépes, minimizing the surgical trauma of surrounding tissues. Thorough curettage of the alveolus will be performed at the time of extraction to ensure removal of all granulation tissue and stimulate bleeding from the bone base, to form blood clot and promote healing. The sutures will be removed after 7 days of surgery, except for patients in group 3, in which sutures will not be made.

PROCEDURE

installation of dental implant and collection of biological material

The material was collected for histological analysis, extracted with trephine drill of 2.0 mm in diameter. Samples were removed before the incision. A linear incision was then made on the alveolar ridge in the region and flap detachment. The initial insertion of the implant was performed using the contra-angle at 30 rpm, the final insertion of the implant was performed with manual torque wrench, where the insertion torque was measured and the value was tabulated, not exceeding 60 N. cm. The component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. The prosthetic component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. the tabulated values and the incision was sutured.

DEVICE

ISQ analysis

The prosthetic component already installed. On it is adapted the SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden). According to the manufacturer, the device generates a series of signals with different frequencies in Hertz (Hz) and these values are immediately converted to ISQ (Implantation Stability Coefficient), providing fast and accurate monitoring. The calibration is performed on the buccal and palatal surfaces of the intermediaries, that is, each implant was submitted to 2 readings. The readings were captured and tabulated for further analysis. were repeated at intervals of 7 to 10 days, 30 days and 60 days, for evaluation of SSI in the period of osseointegration. With the objective of not subjecting the implant to torque and torque during this period and to avoid interfering with the osseointegration process, the micro-pillars were covered with the micro-pillar protection screws with digital pressure only.

Sponsors & Collaborators

  • Federal University of Juiz de Fora

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-06-25
Completion
2020-08-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973190 on ClinicalTrials.gov