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Is there a difference in pain perception between ultrasonic scalers?


- candidate number13720
- NTR NumberNTR3693
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2012
- Secondary IDs12/264 METc VUmc
- Public TitleIs there a difference in pain perception between ultrasonic scalers?
- Scientific TitleComparison of ultrasonic devices with regard to comfort in periodontal patients during recall.
- ACRONYM
- hypothesisPatients will prefer power scalers over hand instruments.
- Healt Condition(s) or Problem(s) studiedUltrasonic scalers, Periodontal maintenance, Supportive periodontal therapy, Pain perception
- Inclusion criteria1. Supportive periodontal therapy patient;
2. ≥ 18 years;
3. ≥ 5 teeth each quadrant;
4. Probing pocket depths ≤ 6 mm;
5. ASA I / ASA II (American Society of Anesthesiologists).
- Exclusion criteria1. Dental implants;
2. Fixed orthodontic device;
3. Artificial cardiac pacemaker.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate31-mrt-2013
- Target number of participants100
- InterventionsUsing 3 power devices en manual cleaning. Each device will be used in one quadrant (randomly assigned). After each quadrant the patient will fill out a pain scale (VAS).

Research group:
There will be a group of 100 selected patients which reveive SOT (supportive periodontal therapy).

Clinical procedures:
Each patient will be treated with hand instruments and 3 power scalers during SOT. Each method will be used in 1 quadrant, this will be randomly assigned. Order of treatment of the teeth will be Q1 (quadrant), subsequently Q2, Q3, Q4.

Randomization:
The study is designed as a prospective single session, randomized cross-over clinical trial. 100 subjects will be treated with 4 different methods during SOT. Order of the methods will be randomly assigned.

Lost to follow-up:
With respect to possibility of drop out, the short study period does not have a serious risk of a considerable number of subject that may be lost to follow-up.
- Primary outcome1. Pain;
2. Visual Analogue Scale.
- Secondary outcome1. Comfort;
2. Visual Analogue Scale.
- TimepointsAfter each quadrant.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Armin Soltanpour
- CONTACT for SCIENTIFIC QUERIES Armin Soltanpour
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
HU-Friedy
- PublicationsN/A
- Brief summaryThe standard non-surgical treatment for periodontal disease is supra- and subgingival scaling to disrupt and thoroughly remove biofilm, calculus deposits, periodontal pathogens, and debris. Supra- and subgingival scaling can be performed with hand instruments or with power scalers. A less painful treatment might increase patient compliance and may give a better prognosis for periodontal therapy.

The purpose of the study is to document pain perception on a visual analogue scale (VAS) during supportive periodontal therapy with hand instruments and three different power scalers. In order to investigate which method is of most comfort for the patient.
- Main changes (audit trail)
- RECORD6-nov-2012 - 24-nov-2012


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