An interventional study of Dental Implantation with high torque and Dental Implantation with low torque in Dental Implantation, sponsored by Ege University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Ege University · Not applicable, Interventional, and Treatment
The objective of this observational study is to evaluate the primary stability of dental implants and the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (VAS)
Primary implant stability plays a key role in providing osseointegration. Higher insertion torque indicates higher primary stability. However, the effect of increased insertion torque on patient pain levels has not been clearly demonstrated. Several methods for measuring primary stability have been defined so far. Insertion torque, periotest measurements, and resonance frequency analysis are mostly preferred due to their ease of use and non-invasiveness.
The aim of the present study is to evaluate the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (VAS) and to assess the relationship between insertion torque, periotest measurements, and resonance frequency analysis.
Ege University is the lead sponsor of 375 studies on the registry; 47 are open to participants now.
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Exclusion Criteria
Fifteen patients (eight females and seven males) with a single-tooth deficiency bilaterally in the molar region of the lower jaw were included in the study. Implant placement with high insertion torque was planned on one side of the jaw. The implant drills were applied as recommended by the company. To achieve high insertion torque, the single-use final drill from the implant box was not used in the high torque group.
Procedure: Dental Implantation with high torque
Fifteen patients (eight females and seven males) with a single-tooth deficiency bilaterally in the molar region of the lower jaw were included in the study. Implant placement with low insertion torque was planned on the otherside of the jaw. The implant drills were applied as recommended by the company. To achieve low insertion torque, the single-use final drill was applied two times.
Procedure: Dental Implantation with low torque
Fifteen patients with bilateral single-tooth loss in the posterior mandible will be included in the study. One implant was randomly placed with high insertion torque in each patient. A total of 15 implants will be placed, and insertion torque values will be recorded.
Fifteen patients with bilateral single-tooth loss in the posterior mandible will be included in the study. One implant was randomly placed with low insertion torque in each patient. A total of 15 implants will be placed, and insertion torque values will be recorded.
Pain levels assessed with the visual analogue scale (VAS)
Patients will be asked to record the number of painkillers taken each day and evaluate their pain levels using a 0-10 VAS form before and after the operation. A score of 0 indicated no pain while 10 indicated the worst pain possible. A VAS score of 1-3 indicated mild pain, 4-6 indicated moderate pain, and 7-10 indicated very severe pain.
Time frame: 7 days
Insertion torque values
After the implant slots were prepared, the coronal part of the implants (MIS Implant Technologies, Bar Lev Industrial Park, Israel) were placed into the slots at 25 rpm without irrigation until the coronal part was at the same level with the ridge top. The maximum insertion torque was recorded while the implants were placed with the help of a physiodispenser that can measure the insertion torque (Kavo Expertsurg lux physiodispenser, KaVo Dental GmbH, Biberach, Germany).
Time frame: 1 day
Periotest measurements
Measurements were made with the Periotest (Siemens AG, Bensheim, Germany) device and recorded as PTV (perio test value).
Time frame: 1 day
Resonance frequency analysis values
A SmartPeg (Integration Diagnostics AB; Gothenburg, Sweden) suitable for the implant was attached to measure primary implant stability with radiofrequency. Radiofrequency analysis was performed in both mesiodistal and buccolingual directions with the Osstell Mentor (Integration Diagnostics AB; Gothenburg, Sweden) device and the measurements were recorded.
Time frame: 1 day
No study locations are listed for this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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