Influence of Scaler Tip Design on Patients' Pain Perception

• ClinicalTrials.gov Identifier: NCT04623723
• Recruitment Status: Completed
• First Posted: November 10, 2020
• Last Update Posted: November 12, 2020
• Sponsor: University of Malaya
• Information provided by (Responsible Party): Nor Adinar Baharuddin, University of Malaya

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Other: PS (DS-016A, EMS® Piezon, Switzerland) scaler tips. ); Other: Conventional (FS-407, EMS® Piezon, Switzerland)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Masking Description: Single blinded (subject)
• Primary Purpose: Prevention
• Official Title: Influence of Scaler Tip Design on Patients' Pain Perception
• Actual Study Start Date: March 14, 2017
• Actual Primary Completion Date: October 14, 2017
• Actual Study Completion Date: December 14, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Malaysia

Faculty of Dentistry

Kuala Lumpur, Malaysia, 50603

Sponsors and Collaborators

University of Malaya

More Information

Publications of Results:

Berggren U, Meynert G. Dental fear and avoidance: causes, symptoms, and consequences. J Am Dent Assoc. 1984 Aug;109(2):247-51.

Jepsen S, Ayna M, Hedderich J, Eberhard J. Significant influence of scaler tip design on root substance loss resulting from ultrasonic scaling: a laserprofilometric in vitro study. J Clin Periodontol. 2004 Nov;31(11):1003-6.

Kawashima H, Sato S, Kishida M, Ito K. A comparison of root surface instrumentation using two piezoelectric ultrasonic scalers and a hand scaler in vivo. J Periodontal Res. 2007 Feb;42(1):90-5.

Teughels W, Van Assche N, Sliepen I, Quirynen M. Effect of material characteristics and/or surface topography on biofilm development. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:68-81.

von Troil B, Needleman I, Sanz M. A systematic review of the prevalence of root sensitivity following periodontal therapy. J Clin Periodontol. 2002;29 Suppl 3:173-7; discussion 195-6. Review.

Lea SC, Landini G, Walmsley AD. Displacement amplitude of ultrasonic scaler inserts. J Clin Periodontol. 2003 Jun;30(6):505-10.

Lea SC, Landini G, Walmsley AD. Ultrasonic scaler tip performance under various load conditions. J Clin Periodontol. 2003 Oct;30(10):876-81.

Lea SC, Landini G, Walmsley AD. The effect of wear on ultrasonic scaler tip displacement amplitude. J Clin Periodontol. 2006 Jan;33(1):37-41.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abdul Hayei NA, Yahya NA, Safii SH, Saub R, Vaithilingam RD, Baharuddin NA. Influence of scaler tip design on root surface roughness, tooth substance loss and patients' pain perception: an in vitro and a randomised clinical trial. BMC Oral Health. 2021 Mar 31;21(1):169. doi: 10.1186/s12903-021-01540-0.

• Responsible Party: Nor Adinar Baharuddin, Associate Professor, University of Malaya
• ClinicalTrials.gov Identifier: NCT04623723
• Other Study ID Numbers: 101269-5
• First Posted: November 10, 2020
• Last Update Posted: November 12, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No