Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children

July 31, 2026 updated by: DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital

Evaluation of the Effects of Different Local Anesthesia Techniques on Dental Anxiety and Pain During Vital Pulp Therapy

This prospective observational study aims to evaluate the effects of different local anesthesia techniques on dental anxiety and pain in children undergoing vital pulp therapy of permanent mandibular first molars. Conventional inferior alveolar nerve block and two computer-controlled local anesthetic delivery (CCLAD) systems used in routine clinical practice will be compared. The choice of anesthesia technique will be based on the clinician's routine decision-making, and no additional intervention or modification of standard treatment will be performed for research purposes. Dental anxiety, pain, physiological parameters, and postoperative complications will be assessed using validated clinical scales and routine clinical measurements. The findings may help improve pain and anxiety management during pediatric dental treatment while supporting evidence-based selection of local anesthesia techniques.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of children aged 8-10 years who require vital pulp therapy of permanent mandibular first molars and attend the Department of Pediatric Dentistry at Recep Tayyip Erdoğan University Faculty of Dentistry. Eligible participants will be systemically healthy children with appropriate cognitive and communication abilities and acceptable cooperation levels according to the Frankl Behavior Rating Scale (scores 3 or 4). Participants will be evaluated according to the routine clinical care provided, and the effects of different local anesthesia techniques on dental anxiety, pain response, physiological parameters, and postoperative outcomes will be assessed.

Description

Inclusion Criteria:

  • Children aged 8-10 years.
  • Children and parents/legal guardians who agree to participate in the study and provide informed consent.
  • Patients requiring vital pulp therapy of a permanent mandibular first molar.
  • Patients classified as Frankl Behavior Rating Scale score 3 or 4. Systemically healthy children (ASA I).
  • Children with adequate cognitive and communication abilities to understand the study procedures and pain/anxiety assessment scales.
  • Permanent mandibular first molars without clinical or radiographic signs of abscess, fistula, or periapical pathology.

Exclusion Criteria:

  • Children with systemic diseases or medical conditions affecting dental treatment.
  • Children classified as Frankl Behavior Rating Scale score 1 or 2.
  • Patients with known allergy or hypersensitivity to local anesthetic agents (e.g., lidocaine, articaine).
  • Teeth with acute dental infection signs, including abscess, cellulitis, or extensive infection.
  • Teeth showing clinical or radiographic evidence of periapical pathology.
  • Children unable to understand or complete pain and anxiety assessment scales due to cognitive, visual, hearing, or communication limitations.
  • Patients who do not comply with the study procedures or withdraw consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Conventional Inferior Alveolar Nerve Block
Participants in this cohort receive conventional inferior alveolar nerve block anesthesia as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the anesthesia procedure is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
QuickSleeper Computer-Controlled Local Anesthesia
Participants in this cohort receive computer-controlled local anesthetic delivery using the QuickSleeper system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the routine treatment protocol is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
Controlled Local Anesthetic Delivery System Group
Participants in this cohort receive computer-controlled local anesthetic delivery using the SOAN system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The SOAN system allows controlled administration of local anesthetic solution with regulated flow and pressure during the injection procedure. The anesthesia technique is selected by the treating clinician according to standard clinical practice and clinical requirements. No additional intervention, modification of the routine treatment protocol, or procedure solely for research purposes is performed. Dental anxiety, pain responses, physiological parameters, and postoperative outcomes are evaluated and recorded during and after the routine dental treatment process.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Response During Local Anesthesia Administration
Time Frame: During local anesthesia administration
Pain response during local anesthesia administration will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale evaluates behavioral pain responses in children based on five domains: facial expression, leg movement, activity, crying, and consolability. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
During local anesthesia administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dental Anxiety Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf)
Time Frame: Baseline (before treatment) and immediately after completion of treatment
Dental anxiety levels will be evaluated using the Modified Child Dental Anxiety Scale-Faces version (MCDASf). The scale includes eight dental situations rated on a five-point Likert scale ranging from 1 (relaxed/not anxious) to 5 (very anxious). Total scores range from 8 to 40, with higher scores indicating higher levels of dental anxiety.
Baseline (before treatment) and immediately after completion of treatment
Immediate Emotional Status Assessed by the Facial Image Scale (FIS)
Time Frame: Before anesthesia administration and after local anesthesia administration
The Facial Image Scale (FIS) will be used to evaluate children's immediate emotional status and dental anxiety. The scale consists of five facial expressions ranging from very happy to very unhappy. Higher scores indicate increased anxiety levels.
Before anesthesia administration and after local anesthesia administration
Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale
Time Frame: Immediately after completion of treatment
Pain intensity after completion of vital pulp therapy will be assessed using the Wong-Baker Faces Pain Rating Scale. The scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.
Immediately after completion of treatment
Heart Rate
Time Frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Heart rate (beats per minute) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Postoperative Complications After Vital Pulp Therapy
Time Frame: 24 hours after treatment
Postoperative complications following vital pulp therapy will be assessed by contacting parents 24 hours after treatment. The presence or absence of postoperative symptoms will be recorded.
24 hours after treatment
Blood Pressure
Time Frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Systolic and diastolic blood pressure (mmHg) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Peripheral Oxygen Saturation (SpO₂)
Time Frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Peripheral oxygen saturation (%) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Body Temperature
Time Frame: Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Body temperature (°C) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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