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

NCT06779448 | Completed

• 1 other identifier: 2024/0242
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• blood pressure

  systolic blood pressure and diastolic blood pressure for the children recorded. Systolic and diastolic blood pressure were measured using an automatic blood pressure monitor (mmHg). (min 20 mmHg- max 320 mmHg) The mean values and standard deviations of these measured values be taken into account.

  one week intervals about observation/treatment sessions (total time is 2 weeks)

• pulse rate

  pulse rate for the children and the operator recorded. Pulse rate was evaluated with a fingertip pulse oximeter (unit per minute) (min 60- max 160). The mean values and standard deviations of these measured values be taken into account.

  one week intervals about observation/treatment sessions (total time is 2 weeks)

Secondary Outcomes (2)

• pain perception

  one week intervals about observation/treatment sessions (total time is 2 weeks)

• pain perception

  one week intervals about observation/treatment sessions (total time is 2 weeks)

Study Arms (4)

local anesthesia

ACTIVE COMPARATOR

local anesthesia application before rubber dam isolation

Other: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist; Other: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

topical anesthesia

ACTIVE COMPARATOR

topical anesthesia application before rubber dam isolation

Other: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist; Other: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

rubber dam

ACTIVE COMPARATOR

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

Other: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist; Other: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

cotton roll

ACTIVE COMPARATOR

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

Other: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments; Other: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist; Other: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist

Interventions

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

cotton roll; local anesthesia; rubber dam; topical anesthesia

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

cotton roll; local anesthesia; rubber dam; topical anesthesia

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

Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist 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; local anesthesia; rubber dam; topical anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İzmir Katip Celebi University

Izmir, 35640, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 22404253 BACKGROUND

• 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.

  PMID: 37328861 BACKGROUND

• 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.

  PMID: 27648846 BACKGROUND

• 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.

  PMID: 40448060 DERIVED

MeSH Terms

Conditions

Toothache

Interventions

Dentists

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Staff; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• TUGBA OZDEMIR, RES ASİST

  İZMİR KATIP CELEBI UNİVERSİTY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: randomized, controlled, single-blinded, split mouth clinical study

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: January 16, 2025
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)