Skip to main content
OpenTrials
Completed

NCT Number: NCT06176287

Assessment of Pain Associated With Insertion Torque and Correlation of Primary Implant Stability Measurement Methods

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

DENTAL IMPLANTATION

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • No contraindications for implant surgery;
  • Bilateral single-tooth loss in the posterior mandible;
  • Sufficient bone amount for implant diameter and height at the implant site;
  • At least 3 months after tooth extraction at the implant site;

Exclusion criteria

  • History of chronic infection or pain at the implant site;
  • History of radiotherapy to the head and neck region for any reason;
  • Local or systemic causes of persistent anti-inflammatory or analgesic medication;
  • Patients with suspicion of pregnancy.

Treatment and study plan

Dental Implantation with high torque

Procedure

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.

Dental Implantation with low torque

Procedure

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.

Primary outcomes

  1. Pain levels assessed with the visual analogue scale (VAS)

    Time frame: 7 days

    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.

Secondary outcomes

  1. Insertion torque values

    Time frame: 1 day

    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).

  2. Periotest measurements

    Time frame: 1 day

    Measurements were made with the Periotest (Siemens AG, Bensheim, Germany) device and recorded as PTV (perio test value).

  3. Resonance frequency analysis values

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • MIS Implant Technologies, Ltd

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2023
Registry last updated
Dec 19, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.