Dental AnxietyNCT06779448
The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children
A study testing Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments, Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments and Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist in people with Dental Anxiety and Dental Fear, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Fear, Rubberdam
- What is being tested?
- Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments, Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments and Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments, Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments, Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist, Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist
- Keywords
- dental anxiety, local anesthesia, topical anesthesia, rubber dam, cotton roll, dental stress, stress parameters
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of objective and subjective stress parameters caused by local anesthesia during treatmentsOther
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 treatmentsOther
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 dentistOther
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 dentistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| local anesthesia | Active comparator | local anesthesia application before rubber dam isolation Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one week intervals about observation/treatment sessions (total time is 2 weeks)
Secondary outcomes (2)
pain perception
Pain perception assessed subjectively post-procedure using the Wong-Baker FACES Pain Rating Scale (WBFPRS). The aforementioned assessments conducted through the assignment of scores. Wong-baker (WBFPRS) is realised as scoring from facial expressions. The lowest score selected from 6 different and graded facial expressions gives the lowest anxiety value (min 0- max 6).
Measured: one week intervals about observation/treatment sessions (total time is 2 weeks)
pain perception
Pain perception is going to assess subjectively post-procedure using the Visual Analogue Scale (VAS). The aforementioned assessments conducted through the assignment of scores. VAS takes values ranging from 0-10 and higher values indicate an increase in patients pain perception. 0 is indicated no pain and 10 is indicated worst possible pain.
Measured: one week intervals about observation/treatment sessions (total time is 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jul 2024
- Primary completion1 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, single-blinded, split mouth clinical study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru KUCUKYİLMAZ, Izmir Katip Celebi University
- Investigators
- TUGBA OZDEMIR, RES ASİST, Principal investigator, İZMİR KATIP CELEBI UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779448
- Sponsor's protocol ID
- 2024/0242
- Status last verified
- Jul 2025
- First submitted
- 4 Dec 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to concerns about the security of unpublished data
Publications
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.
PubMed 22404253Afshari 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.
PubMed 37328861Wang 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.
PubMed 27648846Kucukyilmaz 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.
PubMed 40448060
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children
- ClinicalTrials.gov ID
- NCT06779448
- Acronym / sponsor ID
- 2024/0242
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized, controlled, single-blinded, split mouth clinical study
| Arm | Type | Receives |
|---|---|---|
| local anesthesia | Active comparator | 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 dentistlocal anesthesia application before rubber dam isolation |
| topical anesthesia | Active comparator | 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 dentisttopical anesthesia application before rubber dam isolation |
| rubber dam | Active comparator | 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 dentistRubber dam isolation and evaluation of the associated objective and subjective stress parameters |
| cotton roll | Active comparator | 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 dentistcotton roll insulation and evaluation of the associated objective and subjective stress parameters |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of objective and subjective stress parameters caused by local anesthesia during treatmentsPatients 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 | cotton roll, local anesthesia, rubber dam, topical anesthesia |
| Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatmentsPatients 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 | 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 dentistPatients 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 | 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 dentistPatients 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 | cotton roll, local anesthesia, rubber dam, topical anesthesia |
Primary outcome
blood pressure
Time frame: one week intervals about observation/treatment sessions (total time is 2 weeks)
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.
pulse rate
Time frame: one week intervals about observation/treatment sessions (total time is 2 weeks)
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.
2 secondary outcomes
pain perception
Time frame: one week intervals about observation/treatment sessions (total time is 2 weeks)
pain perception
Time frame: one week intervals about observation/treatment sessions (total time is 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 22404253Ammann 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.
- Background: PubMed 37328861Afshari 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.
- Background: PubMed 27648846Wang 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.
- Derived from this study: PubMed 40448060Kucukyilmaz 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.
- Individual participant dataSharing planned: No. due to concerns about the security of unpublished data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA OZDEMIR, RES ASİST principal investigator
İZMİR KATIP CELEBI UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments, Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments and Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist in people with Dental Anxiety and Dental Fear, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: one week intervals about observation/treatment sessions (total time is 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06779448, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.