The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children

NCT ID: NCT06779448

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-11-01

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.

Conditions

Dental Anxiety; Dental Fear; Rubberdam; Anesthesia, Dental; Dental Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

local anesthesia

local anesthesia application before rubber dam isolation

Group Type: ACTIVE_COMPARATOR

Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments

Intervention Type: OTHER

Patients were divided according to the randomization procedure. infiltration anesthesia (Maxicaine Forte, Artikain, VEM Drug, Turkey) was performed with a 20-gauge needle. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments

Intervention Type: OTHER

Patients were divided i according to the randomization procedure. The topical anesthetic agent (EMLA, AstraZeneca, Cotia, São Paulo, Brazil) was applied using a disposable dental Q-tip for 10-20 seconds. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

topical anesthesia

topical anesthesia application before rubber dam isolation

Group Type: ACTIVE_COMPARATOR

Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments

Intervention Type: OTHER

Patients were divided according to the randomization procedure. infiltration anesthesia (Maxicaine Forte, Artikain, VEM Drug, Turkey) was performed with a 20-gauge needle. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments

Intervention Type: OTHER

Patients were divided i according to the randomization procedure. The topical anesthetic agent (EMLA, AstraZeneca, Cotia, São Paulo, Brazil) was applied using a disposable dental Q-tip for 10-20 seconds. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

rubber dam

Rubber dam isolation and evaluation of the associated objective and subjective stress parameters

Group Type: ACTIVE_COMPARATOR

Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments

Intervention Type: OTHER

Patients were divided according to the randomization procedure. infiltration anesthesia (Maxicaine Forte, Artikain, VEM Drug, Turkey) was performed with a 20-gauge needle. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments

Intervention Type: OTHER

Patients were divided i according to the randomization procedure. The topical anesthetic agent (EMLA, AstraZeneca, Cotia, São Paulo, Brazil) was applied using a disposable dental Q-tip for 10-20 seconds. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

cotton roll

cotton roll insulation and evaluation of the associated objective and subjective stress parameters

Group Type: ACTIVE_COMPARATOR

Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments

Intervention Type: OTHER

Patients were divided according to the randomization procedure. infiltration anesthesia (Maxicaine Forte, Artikain, VEM Drug, Turkey) was performed with a 20-gauge needle. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments

Intervention Type: OTHER

Patients were divided i according to the randomization procedure. The topical anesthetic agent (EMLA, AstraZeneca, Cotia, São Paulo, Brazil) was applied using a disposable dental Q-tip for 10-20 seconds. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

Intervention Type: OTHER

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Interventions

Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments

Patients were divided according to the randomization procedure. infiltration anesthesia (Maxicaine Forte, Artikain, VEM Drug, Turkey) was performed with a 20-gauge needle. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Intervention Type: OTHER

Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments

Patients were divided i according to the randomization procedure. The topical anesthetic agent (EMLA, AstraZeneca, Cotia, São Paulo, Brazil) was applied using a disposable dental Q-tip for 10-20 seconds. Following the administration of anesthetic, an appropriate size rubber dam and metal clamp was placed i and pit and fissure sealant was applied. 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.

Intervention Type: OTHER

Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Intervention Type: OTHER

Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

Patients were divided into 4 subgroups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp and also cotton roll application other side of the arch. 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 and dentist were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

Intervention Type: OTHER

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.

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Ebru KUCUKYİLMAZ

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TUGBA OZDEMIR, RES ASİST

Role: PRINCIPAL_INVESTIGATOR

İZMİR KATIP CELEBI UNİVERSİTY

Locations

İzmir Katip Celebi University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 22404253 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37328861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27648846 (View on PubMed)

Kucukyilmaz E, Ozdemir T, Savas S. The effect of rubber dam on objective and subjective parameters of stress during dental treatment in children: a randomized clinical trial. BMC Oral Health. 2025 May 30;25(1):855. doi: 10.1186/s12903-025-06250-5.

Reference Type: DERIVED

PMID: 40448060 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2024/0242

Identifier Type: -

Identifier Source: org_study_id