Clinical trial NCT06779448: The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children
Official title: The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Dental Fear
Rubberdam
Anesthesia, Dental
Dental Pain
Keywords: dental anxiety
local anesthesia
topical anesthesia
rubber dam
cotton roll
dental stress
stress parameters
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, single-blinded, split mouth clinical study
Primary purpose: OTHER

Brief summary: Although rubber dam application provides many advantages, several pediatric dentists avoid using it, arguing that it may increase stress for young patients.

The purpose of this clinical study was to evaluate the effect of rubber dam on the subjective and objective stress in children and the effects of preferred anesthesia methods during use of the rubber dam on the same parameters.

A total of 100 children, aged 6-12 years old participated in this study. The selected site of the patients divided cotton roll and rubber dam application group, and the rubber dam group divided also two subgroups as topical and infiltration anesthesia application. Objective parameters of stress of the patients and pulse rate of the operator were measured at three different time points. Pain perception was also evaluated subjectively. The data were statistically analyzed (p\<0.05).

Detailed description: This randomized, controlled, single-blinded study included 100 healthy, cooperative children (Frankl Scale, Rating 3-4) aged 6-12 years, classified as ASA I (american assossiation of anesthesiologist), 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. 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: immediately after sitting in the treatment chair and prior to the beginning of the treatment (T1), after light curing of the fissure sealant with cotton roll isolation (T2), and following the completion of treatment and removal of the cotton rolls. Systolic and diastolic blood pressure were measured using an automatic blood pressure monitor (OMRON M2, Omron Healthcare Co., Kyoto, Japan). Pulse rate was evaluated with a fingertip pulse oximeter (LYG88 Pulse Oximeter, China). 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. At this stage, the teeth were cleaned like in cotton roll group, and the patients were divided into two groups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp. The topical anesthetic agent (EMLA, AstraZeneca, Cotia, São Paulo, Brazil) was applied using a disposable dental Q-tip for 10-20 seconds and infiltration anesthesia (Maxicaine Forte, Artikain, VEM Drug, Turkey) was performed with a 20-gauge needle. Following the administration of anesthetics, an appropriate size rubber dam and metal clamp was placed in the mandibular arch, and pit and fissure sealant was applied to the opposite arch. The stress parameters of the subjects were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Eligibility criteria: Inclusion Criteria:

* 6-12 years child,
* classified as ASA I (american assossiation of anesthesiologist)
* cooperative children
* child with bilateral fully erupted mandibular first permanent molars requiring pit and fissure sealant procedures.

Exclusion Criteria:

* patients/guardians who do not meet the inclusion criteria
* patients/guardians who do not agree to participate in the study.
* child with chronic systemic disease
* non-cooperative children

Primary outcomes:
measure: blood pressure
timeFrame: one week intervals about observation/treatment sessions (total time is 2 weeks)
measure: pulse rate
timeFrame: one week intervals about observation/treatment sessions (total time is 2 weeks)
Secondary outcomes:
measure: pain perception
timeFrame: one week intervals about observation/treatment sessions (total time is 2 weeks)
measure: pain perception
timeFrame: one week intervals about observation/treatment sessions (total time is 2 weeks)
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: İzmir Katip Celebi University
Study officials:
affiliation: İZMİR KATIP CELEBI UNİVERSİTY
name: TUGBA OZDEMIR, RES ASİST
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ammann P, Kolb A, Lussi A, Seemann R. Influence of rubber dam on objective and subjective parameters of stress during dental treatment of children and adolescents - a randomized controlled clinical pilot study. Int J Paediatr Dent. 2013 Mar;23(2):110-5. doi: 10.1111/j.1365-263X.2012.01232.x. Epub 2012 Mar 8.
citation: Afshari E, Sabbagh S, Khorakian F, Sarraf Shirazi A, Akbarzadeh Baghban A. Reducing pain and discomfort associated with rubber dam clamp placement in children and adolescents: a systematic review and meta-analysis of effectiveness. BMC Oral Health. 2023 Jun 16;23(1):398. doi: 10.1186/s12903-023-03115-7.
citation: Wang Y, Li C, Yuan H, Wong MC, Zou J, Shi Z, Zhou X. Rubber dam isolation for restorative treatment in dental patients. Cochrane Database Syst Rev. 2016 Sep 20;9(9):CD009858. doi: 10.1002/14651858.CD009858.pub2.