|- candidate number||13720|
|- NTR Number||NTR3693|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-nov-2012|
|- Secondary IDs||12/264 METc VUmc|
|- Public Title||Is there a difference in pain perception between ultrasonic scalers?|
|- Scientific Title||Comparison of ultrasonic devices with regard to comfort in periodontal patients during recall.|
|- hypothesis||Patients will prefer power scalers over hand instruments.|
|- Healt Condition(s) or Problem(s) studied||Ultrasonic scalers, Periodontal maintenance, Supportive periodontal therapy, Pain perception|
|- Inclusion criteria||1. 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 criteria||1. Dental implants;|
2. Fixed orthodontic device;
3. Artificial cardiac pacemaker.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2013|
|- planned closingdate||31-mrt-2013|
|- Target number of participants||100|
|- Interventions||Using 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).
There will be a group of 100 selected patients which reveive SOT (supportive periodontal therapy).
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.
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 outcome||1. Pain;|
2. Visual Analogue Scale.
|- Secondary outcome||1. Comfort;|
2. Visual Analogue Scale.
|- Timepoints||After each quadrant.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Armin Soltanpour|
|- CONTACT for SCIENTIFIC QUERIES|| Armin Soltanpour|
|- Sponsor/Initiator ||Academic Center Dentistry Amsterdam (ACTA)|
(Source(s) of Monetary or Material Support)
|- Brief summary||The 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)|
|- RECORD||6-nov-2012 - 24-nov-2012|