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

NCT06176287 | Completed

• 1 other identifier: 16-3.2/9
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Dental Implantation

Keywords

dental implants; dental implantation; pain assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Insertion torque values

  1 day

• Periotest measurements

  1 day

• Resonance frequency analysis values

  1 day

Study Arms (2)

High insertion torque group

ACTIVE COMPARATOR

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

Low insertion torque group

ACTIVE COMPARATOR

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

Interventions

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.

High insertion torque group

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.

Low insertion torque group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead
• MIS Implant Technologies, Ltd: collaborator

MeSH Terms

Interventions

Dental Implantation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: December 19, 2023
• Study Start: April 19, 2016
• Primary Completion: September 9, 2016
• Study Completion: October 14, 2016
• Last Updated: December 19, 2023

Record last verified: 2023-12