Influence of Scaler Tip Design on Patients' Pain Perception

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: PS (DS-016A, EMS® Piezon, Switzerland) scaler tips. ); Other: Conventional (FS-407, EMS® Piezon, Switzerland)

• Registration Number: NCT04623723
• Lead Sponsor: University of Malaya

Brief Summary

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.

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 Timeline

• Study Start: 2017-03-14
• Primary Completion: 2017-10-14
• Study Completion: 2017-12-14
• Status Verified: 2020-11
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-09
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Perio Slim (PS)	PS (DS-016A, EMS® Piezon, Switzerland) scaler tips. )	Supragingival scaling with a portable ultrasonic scaler device (EMS®) with PS (DS-016A, EMS® Piezon, Switzerland) scaler tip
Conventional scaler tip	Conventional (FS-407, EMS® Piezon, Switzerland)	Supragingival scaling with a portable ultrasonic scaler device (EMS®) with conventional (FS-407, EMS® Piezon, Switzerland) scaler tip

Primary Outcome Measures

Name	Time	Method
Pain perception	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

Trial Locations

Locations (1)

Faculty of Dentistry; 🇲🇾 Kuala Lumpur, Malaysia