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

Not Applicable

Completed

• Conditions: Dental Implantation
• Interventions: Procedure: Dental Implantation with high torque; Procedure: Dental Implantation with low torque

• Registration Number: NCT06176287
• Lead Sponsor: Ege University

Brief 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)

Detailed 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.

Study Timeline

• Study Start: 2016-04-19
• Primary Completion: 2016-09-09
• Study Completion: 2016-10-14
• Study First Submitted: 2023-10-09
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-09
• Last Update Submitted: 2023-12-09
• Study First Posted: 2023-12-19
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High insertion torque group	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 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.
Low insertion torque group	Dental Implantation with low 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.

Primary Outcome Measures

Name	Time	Method
Pain levels assessed with the visual analogue scale (VAS)	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 Outcome Measures

Name	Time	Method
Insertion torque values	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).
Periotest measurements	1 day	Measurements were made with the Periotest (Siemens AG, Bensheim, Germany) device and recorded as PTV (perio test value).
Resonance frequency analysis values	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.