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

Dental Implantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06176287
• Other study ID #: 16-3.2/9
• Status: Completed
• Phase: N/A
• Start date: April 19, 2016
• Est. completion date: October 14, 2016

Study information

• Verified date: December 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 14, 2016
• Est. primary completion date: September 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implantation

Intervention

Procedure:
• Dental Implantation with high 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.
• 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 low insertion torque in each patient. A total of 15 implants will be placed, and insertion torque values will be recorded.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	MIS Implant Technologies, Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	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).	1 day
Secondary	Periotest measurements	Measurements were made with the Periotest (Siemens AG, Bensheim, Germany) device and recorded as PTV (perio test value).	1 day
Secondary	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.	1 day