Effect of Professional Prophylaxis on Clinical Parameters and Patient Comfort: Randomized Slipt-Mouth Clinical Trial
Phase: NA
Conditions: Dental Plaque, Gum Bleed
Sponsor: University of Lisbon

Effect of Professional Prophylaxis on Clinical Parameters and Patient Comfort: 
Randomized Clinical Trial 
 
 
12/01/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol: 
After the initial evaluation of the participants and their inclusion in the study, the 
participants were randomized in blocks into group A where a conventional protocol was 
used in quadrants I and III and the test protocol in quadrants II and IV, and group B where 
a conventional protocol was used in quadrants II and IV and the test protocol in quadrants 
I and III. 
The observations were made at three different times: baseline, one week after the 
intervention, and three weeks after the intervention. (Figure 1)  
The clinical assessment of each participant was performed using the the Ainamo 
& Bay gingival bleeding index (GBI), the O'Leary plaque control record (PCR) and the 
Silness and Löe plaque index (PI). (26–28) The primary outcome variable of the study 
was the Gingival Bleeding Index (GBI) with the Plaque Index (PI) as a secondary 
outcome variable.  
Hard and soft deposits were removed according to the protocol assigned in one 
appointment performed by the principal investigator the day after the first data collection. 
The control protocol consisted of mechanical scaling with Woodpecker® scaler (Guilin, 
Guangxi, 541004 P.R.China) at power 1, followed by stain removal and polishing with 
R&S RUBBER DOME (R&S® Dental products 25, Rue Bleue - 75009 Paris) with 
Prophy Paste CCS® polishing paste RDA 250 (Directa AB P.O. Box 723, SE-194 27 
Upplands Väsby, Sweden) at a speed of 10,000 rotations per minute.  
The test protocol consisted in an assessment of the periodontal status following 
the application of the plaque discloser (Biofilm Discloser, Dr. Wittmann GmbH & Co 
KG 64673 Zwingenberg - Germany), followed by oral hygiene instructions and biofilm 
removal with an erythritol jet (Airflow Plus Powder®, Electro Medical Systems S.A.), 
Chemin de la Vuarpillière, 31, 1260 Nyon - Switzerland) with the Airflow Prophylaxis 

Master® device (Electro Medical Systems S.A., Chemin de la Vuarpillière, 31, 1260 
Nyon - Switzerland). The jet stream was used at a power of 3 and the irrigation at a power 
of 10. Calculus removal was then performed with the piezon scaller of the same device 
using a PS scaler tip (Electro Medical Systems® S.A., Chemin de la Vuarpillière, 31, 
1260 Nyon - Switzerland). 
The first follow-up assessment (T1) was performed one week after the 
intervention, and the second follow-up assessment (T2) was performed 3 weeks after the 
intervention performed by the same research assistant that performed the initial 
assessment (T0). indecesThe precision and accuracy of the data collection was ensured 
by calibrating the instruments used and the investigators to minimize and control possible 
measurement errors. The assistant investigator underwent calibration before the start of 
the study to train the indeces, followed by a discussion of the criteria with the principal 
investigator.  
After the appointment the participant rated comfort using a Visual Analog Scale 
measured on a Likert scale of 0 to 10 for each quadrant.  
 
Statistical Analysis Plan: 
The sample size was calculated for a power of 80% to allow the study to detect a 
difference at the 0.05 significance level when the true difference between treatments is 
0.5 units.  
Data were entered into SPSS® software (Statistical Package for the Social 
Sciences, IBM, Armonk, NY, USA), version 27. 
Descriptive and inferential statistics were performed to evaluate the results of the 
two protocols, with a significance level of 5%. The mean values and standard deviations 
of the clinical parameters were calculated per protocol and per study group, and for the 3 

evaluation moments: for the initial moment (T0), for the evaluation at 1 week (T1), and 
for the final evaluation (T2). 
Comparisons between evaluation moments in each protocol were evaluated using 
the nonparametric Wilcoxon test for paired samples. 
The Mann-Whitney U test was used to analyze differences between protocols.  
The Friedman test was used to analyze the differences between the different evaluation 
periods.