The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children
Phase: NA
Conditions: Dental Anxiety, Dental Fear, Rubberdam, Anesthesia, Dental, Dental Pain
Sponsor: Izmir Katip Celebi University

STUDY PROTOCOL AND STATİSTİCAL ANALYSİS PLAN 
 
TİTLE: The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During 
Dental Treatment in Children 
DOCUMENT DATE: 14.11.2024 
 
RCT: The study was approved by the Medical Ethics Committee of Izmir Katip Celebi 
University, under report No. 2024/0242 
 
STUDY PROTOCOL:  
This randomized, controlled, single-blinded study included 100 healthy, cooperative children 
(Frankl Scale, Rating 3-4) aged 6-12 years, classified as ASA I, with bilateral fully erupted 
mandibular first permanent molars requiring pit and fissure sealant procedures. The inclusion 
criteria were based on the International Caries Detection and Assessment System II,including 
deep and retentive pits and fissures, no restorations, and no evidence of carious lesions.  
The study was planned as split mouth design: For each patient, one tooth was selected 
for rubber dam isolation, while the corresponding tooth from the opposite quadrant was chosen 
for cotton roll isolation. The Rubber dam application group divided also into two groups as 
topical EMLA application, and infiltration anesthesia application. Randomization was 
performed using manually generated sealed envelopes containing information about which 
isolation method and anesthesia technique would be used on which side of the jaw (right or 
left). Random numbers were written on separate papers, folded, and placed in opaque sealed 
envelopes. Each participant chose an envelope and was assigned the printed participant number. 
Each number identified the teeth included in the study, the isolation technique specified for 
each tooth, and the anesthesia method to be used during the rubber dam application.  
After the cleaning procedure, following the randomization result and determination of which 
isolation method would be applied to which side of the patient's jaw, to ensure that the local 
anesthetics used would not affect the patient's cooperation, in the first session, the selected tooth 
was isolated with standard cotton rolls and high-volume suction for the pit and fissure sealing 
procedure on one side of the patient. Cotton rolls were placed in both the lingual and mucco-
buccal side of the arch and the suction was positioned on the lingual side of the tooth. Cotton 
rolls were changed following enamel etching and, in every case, where they became excessively 
moisture throughout the treatment. The fissure sealant procedure was carried out following the 
manufacturer's instructions. Objective stress parameters (pulse rate, systolic blood pressure and 
diastolic blood pressure) for the children and the pulse rate of the operator were recorded at 
three different points. Systolic and diastolic blood pressure were measured using an automatic 
blood pressure monitor. Pulse rate was evaluated with a fingertip pulse oximeter. The operator's 
pulse rate was also recorded. Pain perception was assessed subjectively post-procedure using 
the Wong-Baker FACES Pain Rating Scale (WBFPRS) and Visual Analogue Scale (VAS). One 
week later, the patient was invited to a second appointment for the treatment of the 
corresponding tooth from the opposite side. 
STATİSTİCAL ANALYSİS PLAN 
All statistical analyses of the data were conducted using SPSS statistical software 
Version 21.0 (SPSS Inc., Chicago, IL, USA), with 0.05 selected as the level of significance (α). 
The normality test was conducted using Shapiro-Wilk and the Kolmogorov-Smirnov tests. Data 
were analyzed using Mann-Whitney U and independent samples t-tests. For within-group 
comparisons, Wilcoxon Signed Rank and the Friedman tests were employed.