Influence of Scaler Tip Design on Patients' Pain Perception

November 9, 2020 updated by: Nor Adinar Baharuddin, University of Malaya
Ultrasonic scalers have been shown effective in removing subgingival calculus. However, it may cause alteration to the tooth surface as well as discomfort to patients. Advances in scaler tip designs may reduce these effects. Limited studies have investigated the influence of scaler tip designs on tooth surface and patients' comfort. This study aimed to evaluate the influence of scaler tip designs on patients' pain perception.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Scaling is a common procedure performed by general dental practitioners and dental specialists. Unfortunately, scaling has been associated with unpleasant dental treatment and to some extent, a painful experience (Berggren & Meynert, 1984). Studies also have demonstrated that scaling using ultrasonic scalers can cause tooth surface roughness and tooth substance loss (Jepsen et al., 2004; Kawashima et al., 2007). Rough tooth surface will increase retention of plaque and has been shown associated with early biofilm formation (Teughels et al., 2006). Subsequently, this would increase the risk for development and progression of periodontal disease. Whereas, tooth substance loss may lead to exposed dentinal tubules, and subsequently root sensitivity. Root sensitivity was reported to affect half of patients receiving periodontal therapy (Von Troil et al., 2002). This led to discomfort among patients and avoidance to dental treatment in future.

Advanced development in scaler tip designs has provided opportunities to deliver scaling treatment that is less aggressive to tooth surfaces and most importantly, to reduce the discomfort to patients. The design of the scaler tip has influenced the performance of ultrasonic scalers characterised by the displacement amplitude (Lea et al., 2003b). Displacement amplitude is the lateral movement of scaler tip that is thought to contribute to the aggressiveness of scaling procedure. Several studies have investigated the factors that may influence displacement amplitude, such as power setting and type of generator (Lea et al., 2003a), tip wear (Lea et al., 2006) and scaler tip designs (Lea et al., 2003a). However, to date, there were limited studies that investigated the effect of ultrasonic scaler tip design particularly slim and wide scaler tip on tooth surface roughness, tooth substance loss, and patients' pain perception.

In a clinical setting, if there were two treatment methods that provide similar levels of effectiveness but different levels of discomfort and damage to tooth surface patient will opt for the more comfortable and conservative method. Therefore, this study investigated the influence of scaler tip designs on tpatients' pain perception following scaling.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy patients aged 20-40 years who had anterior maxillary teeth from teeth #13 to #23.
  • Diagnosed with chronic gingivitis and/or mild chronic periodontitis and presented with bleeding on probing (BOP) and minimal calculus from teeth #13 to #23

Exclusion Criteria:

  • Smokers,
  • Patients who had dentinal hypersensitivity, crowns, large restorations, non-vital teeth, acute dental infections or cervical lesions involving teeth #13 to #23.
  • Patients who were on long-term non-steroidal anti-inflammatory drug therapy, undergoing orthodontic treatment or using removable partial dentures involving teeth from teeth #13 to #23

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Perio Slim (PS)
Supragingival scaling with a portable ultrasonic scaler device (EMS®) with PS (DS-016A, EMS® Piezon, Switzerland) scaler tip
Other: PS (DS-016A, EMS® Piezon, Switzerland) scaler tips. )
Supragingival scaling with a portable ultrasonic scaler device (EMS®) with Piezon, Switzerland using PS (DS-016A, EMS® Piezon, Switzerland) scaler tips
Active Comparator: Conventional scaler tip
Supragingival scaling with a portable ultrasonic scaler device (EMS®) with conventional (FS-407, EMS® Piezon, Switzerland) scaler tip
Other: Conventional (FS-407, EMS® Piezon, Switzerland)
Supragingival scaling with a portable ultrasonic scaler device (EMS®) with Piezon, Switzerland using Conventional (FS-407, EMS® Piezon, Switzerland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception
Time Frame: 6 months
Pain perception was assessed using the Visual Analogue Scale (VAS), which consists of a line numbered from 0 to 10. Scale '0' indicates no pain, whereas scale '10' indicates the worst possible pain. Participants were asked to score any number between these two ends that described the pain they experienced during treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2017

Primary Completion (Actual)

October 14, 2017

Study Completion (Actual)

December 14, 2017

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 101269-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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