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

NCT ID: NCT06176287

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-19
• Study Completion Date: 2016-10-14

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.

Conditions

Dental Implantation

Keywords

dental implants; dental implantation; pain assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High insertion torque group

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.

Group Type: ACTIVE_COMPARATOR

Dental Implantation with high torque

Intervention Type: 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.

Low insertion torque group

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.

Group Type: ACTIVE_COMPARATOR

Dental Implantation with low torque

Intervention Type: 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.

Interventions

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.

Intervention Type: 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 low insertion torque in each patient. A total of 15 implants will be placed, and insertion torque values will be recorded.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MIS Implant Technologies, Ltd

INDUSTRY

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Gumus Kanmaz

DDS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

16-3.2/9

Identifier Type: -

Identifier Source: org_study_id