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

NCT06779448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-11

No results posted yet for this study

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).

Conditions

  • Dental Anxiety
  • Dental Fear
  • Rubberdam
  • Anesthesia, Dental
  • Dental Pain

Interventions

OTHER

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.

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.

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.

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.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Principal Investigators

  • TUGBA OZDEMIR, RES ASİST · İZMİR KATIP CELEBI UNİVERSİTY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-09-01
Completion
2024-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06779448 on ClinicalTrials.gov