Dental AnxietyNCT02591797
Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children
A study testing inferior alveolar and lingual nerve block procedure in people with Dental Anxiety and Pain, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of "Hands/Eyes/mouth" behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool… Read more about this study
- Who is it for?
- Ages 36 to 71 months
- Conditions the study is for
- Dental Anxiety, Pain, Infant Behavior
- What is being tested?
- inferior alveolar and lingual nerve block procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Jul 2017
- 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 36 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars
Who cannot join
- Preschool children with history of allergies to lidocaine (local anesthetic)
- Preschool children with systemic or neurological diseases
- Preschool children who have received local dental anesthesia before this study
- Preschool children who do not understand Spanish or Valencian language
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Odontología. Universidad Cardenal Herrera CEU
Valencia, 46010
About this study
Official title: Effectiveness of Hand/Eyes/Mouth Behavior Management Technique in Anxiety, Pain and Behavior Levels During an Inferior Alveolar and Lingual Nerve Block Procedure in Preschool Children: a Randomized Clinical Trial
This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of "Hands/Eyes/mouth" behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.
Read the detailed description
Children will be randomly allocated to treatment groups (n=26 for each group) according to the technique: 1)"Hands/Eyes/mouth" and 2) Conventional. Anxiety and pain will be evaluated by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral Scale Frank
- Conditions
- Dental Anxiety, Pain, Infant Behavior, Heart Rate and Rhythm Disorders
- Being tested
- inferior alveolar and lingual nerve block procedure
- Keywords
- pain, Infant Behavior, Heart rate, Dental Anxiety
- Medical subject headings
- Pain, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior alveolar and lingual nerve block procedureProcedure or surgery
Also called inferior alveolar and lingual nerve block
The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution.
The application of anesthesia shall be in accordance with the following guidelines:
- Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain).
- Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain)
- anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain).
- Syringe: carpule syringe-conventional harpoon with suction system.
| Study group | Role | What they receive |
|---|---|---|
| "hand-eye-mouth" technique | Experimental | "hand-eye-mouth" (MOB) seeks to focus the patient in performing a sequence of movements in a fun way so that your attention is diverted from the puncture dental needle, also it seeks to the patient does not see the needle. The operator prior to infiltrate local anesthetic teaches the child a "game" to put "the sleepy little water".After explain a first time, the sequence once or twice is repeated until the patient has mastered. We call this test. When we apply the anesthetic, the entire sequence must be repeated as in trials with the same tranquility and in the same tone of the game. The operator will use this technique during the inferior alveolar and lingual nerve block procedure Receives: Procedure: inferior alveolar and lingual nerve block procedure |
| Conventional technique | Active comparator | the operator will explain how he/she will do the inferior alveolar and lingual nerve block procedure in phrases appropriates to the child. Then quietly cover the child´s field of view by hand during the inferior alveolar and lingual nerve block Receives: Procedure: inferior alveolar and lingual nerve block procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preschool children´s anxiety levels-Facial Image Scale (FIS)
The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy-FIS)
Measured: Baseline
Secondary outcomes (1)
Preschool children´s pain levels-Wong Baker Faces Pain Scale
The children will be asked to point at which face they felt most like at that moment (row of six faces ranging from very happy-does not hurt to very unhappy-hurt as much as you can imagine)
Measured: At the end of local anesthesia procedure (2 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María Leyda Menéndez, Cardenal Herrera University
- Investigators
- Marta Ribelles Llop, PhD, Study director, Director of Pediatric Dentistry Master. Cardenal Herrera CEU University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591797
- Sponsor's protocol ID
- AMLUCHBR
- Status last verified
- Jul 2017
- First submitted
- 28 Oct 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Leyda-Menendez AM, Vidigal EA, Abanto J, Ribelles-Llop M. Efficacy of two behavioural management techniques during inferior alveolar nerve block administration in pre-school children: a randomised clinical trial. Eur Arch Paediatr Dent. 2023 Feb;24(1):85-93. doi: 10.1007/s40368-022-00758-y. Epub 2022 Oct 19.
PubMed 36260279
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hand/Eyes/Mouth Behavior Management Technique in Anxiety, Pain and Behavior Levels During an Inferior Alveolar and Lingual Nerve Block Procedure in Preschool Children: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02591797
- Acronym / sponsor ID
- AMLUCHBR
- Conditions
- Dental Anxiety, Pain, Infant Behavior, Heart Rate and Rhythm Disorders
- Keywords
- pain, Infant Behavior, Heart rate, Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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.
This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of "Hands/Eyes/mouth" behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.
Detailed description
Children will be randomly allocated to treatment groups (n=26 for each group) according to the technique: 1)"Hands/Eyes/mouth" and 2) Conventional. Anxiety and pain will be evaluated by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral Scale Frank
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "hand-eye-mouth" technique | Experimental | Procedure: inferior alveolar and lingual nerve block procedure"hand-eye-mouth" (MOB) seeks to focus the patient in performing a sequence of movements in a fun way so that your attention is diverted from the puncture dental needle, also it seeks to the patient does not see the needle. The operator prior to infiltrate local anesthetic teaches the child a "game" to put "the sleepy little water".After explain a first time, the sequence once or twice is repeated until the patient has mastered. We call this test. When we apply the anesthetic, the entire sequence must be repeated as in trials with the same tranquility and in the same tone of the game. The operator will use this technique during the inferior alveolar and lingual nerve block procedure |
| Conventional technique | Active comparator | Procedure: inferior alveolar and lingual nerve block procedurethe operator will explain how he/she will do the inferior alveolar and lingual nerve block procedure in phrases appropriates to the child. Then quietly cover the child´s field of view by hand during the inferior alveolar and lingual nerve block |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars
Key exclusion criteria (4 listed)
- Preschool children with history of allergies to lidocaine (local anesthetic)
- Preschool children with systemic or neurological diseases
- Preschool children who have received local dental anesthesia before this study
- Preschool children who do not understand Spanish or Valencian language
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 |
|---|---|---|
| inferior alveolar and lingual nerve block procedureAlso: inferior alveolar and lingual nerve blockThe needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines: 1. Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). 2. Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) 3. anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). 4. Syringe: carpule syringe-conventional harpoon with suction system. | Procedure or surgery | "hand-eye-mouth" technique, Conventional technique |
Primary outcome
Preschool children´s anxiety levels-Facial Image Scale (FIS)
Time frame: Baseline
The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy-FIS)
1 secondary outcome
Preschool children´s pain levels-Wong Baker Faces Pain Scale
Time frame: At the end of local anesthesia procedure (2 minutes)
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 19 Jul 2017.
- Derived from this study: PubMed 36260279Leyda-Menendez AM, Vidigal EA, Abanto J, Ribelles-Llop M. Efficacy of two behavioural management techniques during inferior alveolar nerve block administration in pre-school children: a randomised clinical trial. Eur Arch Paediatr Dent. 2023 Feb;24(1):85-93. doi: 10.1007/s40368-022-00758-y. Epub 2022 Oct 19.
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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.
Marta Ribelles Llop, PhD study director
Director of Pediatric Dentistry Master. Cardenal Herrera CEU University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inferior alveolar and lingual nerve block procedure in people with Dental Anxiety and Pain, run by Cardenal Herrera University at 1 site in Spain.
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 1 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 19 Jul 2017. 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 Spain. 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?
Preschool children´s anxiety levels-Facial Image Scale (FIS) (time frame: Baseline). 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 NCT02591797, which also lists 1 linked publication.
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 19 Jul 2017.