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Influence of Scaler Tip Design on Patients' Pain Perception

NCT ID: NCT04623723

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-14

Study Completion Date

2017-12-14

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single blinded (subject)

Study Groups

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Perio Slim (PS)

Supragingival scaling with a portable ultrasonic scaler device (EMS®) with PS (DS-016A, EMS® Piezon, Switzerland) scaler tip

Group Type SHAM_COMPARATOR

PS (DS-016A, EMS® Piezon, Switzerland) scaler tips. )

Intervention Type OTHER

Supragingival scaling with a portable ultrasonic scaler device (EMS®) with Piezon, Switzerland using PS (DS-016A, EMS® Piezon, Switzerland) scaler tips

Conventional scaler tip

Supragingival scaling with a portable ultrasonic scaler device (EMS®) with conventional (FS-407, EMS® Piezon, Switzerland) scaler tip

Group Type ACTIVE_COMPARATOR

Conventional (FS-407, EMS® Piezon, Switzerland)

Intervention Type OTHER

Supragingival scaling with a portable ultrasonic scaler device (EMS®) with Piezon, Switzerland using Conventional (FS-407, EMS® Piezon, Switzerland)

Interventions

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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

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Nor Adinar Baharuddin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

References

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Berggren U, Meynert G. Dental fear and avoidance: causes, symptoms, and consequences. J Am Dent Assoc. 1984 Aug;109(2):247-51. doi: 10.14219/jada.archive.1984.0328.

Reference Type RESULT
PMID: 6590605 (View on PubMed)

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. doi: 10.1111/j.1600-051X.2004.00601.x.

Reference Type RESULT
PMID: 15491317 (View on PubMed)

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. doi: 10.1111/j.1600-0765.2006.00924.x.

Reference Type RESULT
PMID: 17214645 (View on PubMed)

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. doi: 10.1111/j.1600-0501.2006.01353.x.

Reference Type RESULT
PMID: 16968383 (View on PubMed)

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. doi: 10.1034/j.1600-051x.29.s3.10.x.

Reference Type RESULT
PMID: 12787217 (View on PubMed)

Lea SC, Landini G, Walmsley AD. Displacement amplitude of ultrasonic scaler inserts. J Clin Periodontol. 2003 Jun;30(6):505-10. doi: 10.1034/j.1600-051x.2003.00012.x.

Reference Type RESULT
PMID: 12795788 (View on PubMed)

Lea SC, Landini G, Walmsley AD. Ultrasonic scaler tip performance under various load conditions. J Clin Periodontol. 2003 Oct;30(10):876-81. doi: 10.1034/j.1600-051x.2003.00395.x.

Reference Type RESULT
PMID: 14629574 (View on PubMed)

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. doi: 10.1111/j.1600-051X.2005.00861.x.

Reference Type RESULT
PMID: 16367854 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33789646 (View on PubMed)

Other Identifiers

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101269-5

Identifier Type: -

Identifier Source: org_study_id