No registrations found.
ID
Source
Health condition
Ultrasonic scalers, EMS, Satelec, Symmetry, periodontal maintenance, supportive periodontal therapy, pain perception
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Pain;
2. Visual Analogue Scale.
Secondary outcome
1. Comfort;
2. Visual Analogue Scale.
Background 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.
Study objective
Patients will prefer power scalers over hand instruments.
Study design
After each quadrant.
Intervention
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).
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.
Vrije Universiteit Amsterdam<br>
Academisch Centrum Tandheelkunde Amsterdam
Armin Soltanpour
Amsterdam 1081
The Netherlands
+31 (0)6 83574294
a.soltanpour@student.acta.nl
Vrije Universiteit Amsterdam<br>
Academisch Centrum Tandheelkunde Amsterdam
Armin Soltanpour
Amsterdam 1081
The Netherlands
+31 (0)6 83574294
a.soltanpour@student.acta.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3538 |
NTR-old | NTR3693 |
Other | METc VUmc : 12/264 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |