Dental CariesNCT03140787
Efficacy and Safety of Primary Teeth Anesthesia Using Nasal Spray in Children
A study testing Nasal Spray of Lidocaine HCL and Infiltration injection of Lidocaine HCL in people with Dental Caries, run by Damascus University at 1 site in Syria.
Trial summary
68 healthy children from the Department of Pediatric Dentistry at Damascus University who require treatment for their primary maxillary second molars will be randomly assigned into one of two groups: experimental or control groups. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Nasal Spray of Lidocaine HCL and Infiltration injection of Lidocaine HCL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSyria
- Study dates
- 15 May 2016to 15 Jun 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children between 7-10 years.
- With a need for pulpotomy or a restorative dental procedure requiring local anesthesia for a single vital primary maxillary second molar with no evidence of pulpal necrosis.
- Normal lip, nose, eyelid, and cheek sensation.
- No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride.
Who cannot join
- Frequent bleeding form the nose (≥ 5 per month)
- Inadequately controlled active thyroid disease of any type.
- Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
- History of allergy to or intolerance of lidocaine or epinephrine.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Peadodontics, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: Assessment of Efficacy and Safety of Primary Maxillary Second Molars Anesthesia Using Nasal Spray in Children
68 healthy children from the Department of Pediatric Dentistry at Damascus University who require treatment for their primary maxillary second molars will be randomly assigned into one of two groups: experimental or control groups. In the experimental group, a lidocaine hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper second molar before the commencement of treatment.
To assess the efficacy of this kind of anesthesia, a specific scale will be used by an external observer after capturing some video files of the performed treatment.
Read more
To assess the safety of this procedure, vital signs will be recorded before and after treatment.
Acceptance of the nasal spray will be recorded based on the child's behavior before and after treatment using Frankl scale.
If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2% with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and acceptance will be assessed in the same manner to what is performed in the experimental group.
Read the detailed description
The most common method for anesthetizing maxillary teeth is infiltration injection of an anesthetic agent. This approach carries several disadvantages. First is the child's fear of pain. Infection is also a risk for providers, through exposure to blood-borne pathogens via needle stick.
Fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist.
Importantly, patients' fear of injections can delay needed dental care. Surveys indicate that 30-40 million people in the US avoid going to the dentist because of fear of pain and anesthetic injections.
Therefore an anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a "shot," would greatly benefit dental patients. Further, for procedures involving more than one maxillary tooth on the same side, a trans-nasally applied anesthetic agent that could anesthetize multiple maxillary teeth at once instead of use of repeated infiltration injections would be a major convenience for patients and dentists.
- Conditions
- Dental Caries
- Being tested
- Nasal Spray of Lidocaine HCL, Infiltration injection of Lidocaine HCL
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Spray of Lidocaine HCLDrug
This spray consists of lidocaine hydrochloride-epinephrine hydrochloride
Infiltration injection of Lidocaine HCLDrug
This is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Spray of Lidocaine HCL | Experimental | This group will receive treatment with an application of nasal spray for anesthetization. Receives: Drug: Nasal Spray of Lidocaine HCL |
| Infiltration injection of Lidocaine HCL | Active comparator | Each patient in this group will receive an infiltration injection for anesthetization Receives: Drug: Infiltration injection of Lidocaine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure
Systolic and diastolic blood pressure will be measured.
Measured: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Change in Oxygen Saturation
Oxygen saturation will be measured using a specific device.
Measured: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Change in Respiration Rate
Respiration rate will be measured clinically in the conventional manner.
Measured: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Change in Heart Pulse Rate
Heart pulse rate will be measured clinically in the conventional manner.
Measured: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Change in FLACC scale
This scale will be used to evaluate efficacy. It will be studied by an external observer at 5 stages; first stage: during administration of the drug, second stage: while probing the gingiva around the tooth "buccally, palatally", third stage: when penetration of the dentino-enamel junction occurs, fourth stage: when exposure of the dental pulp occurs, fifth stage: during the removal of the coronal pulp.
Measured: (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20
Change in Frankl scale
This scale will be used to evaluate children's acceptance and will be measured by an external observer at five assessment times.
Measured: (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start15 May 2016
- Primary completion15 May 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Raslan Alzein, DDS, Principal investigator, MSc student, Department of Paedodontics, University of Damascus Dental SchoolShadi Azzawi, DDS MSc PhD, Study director, Senior Lecturer in Paedodontics, Department of Paedodontics, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140787
- Sponsor's protocol ID
- UDDS-Pedo-01-2017
- Status last verified
- Jul 2017
- First submitted
- 14 Apr 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ciancio SG, Hutcheson MC, Ayoub F, Pantera EA Jr, Pantera CT, Garlapo DA, Sobieraj BD, Almubarak SA. Safety and efficacy of a novel nasal spray for maxillary dental anesthesia. J Dent Res. 2013 Jul;92(7 Suppl):43S-8S. doi: 10.1177/0022034513484334. Epub 2013 May 20.
PubMed 23690356Reed KL, Malamed SF, Fonner AM. Local anesthesia part 2: technical considerations. Anesth Prog. 2012 Fall;59(3):127-36; quiz 137. doi: 10.2344/0003-3006-59.3.127.
PubMed 23050753Pandey RK, Bahetwar SK, Saksena AK, Chandra G. A comparative evaluation of drops versus atomized administration of intranasal ketamine for the procedural sedation of young uncooperative pediatric dental patients: a prospective crossover trial. J Clin Pediatr Dent. 2011 Fall;36(1):79-84. doi: 10.17796/jcpd.36.1.1774746504g28656.
PubMed 22900449Hersh EV, Pinto A, Saraghi M, Saleh N, Pulaski L, Gordon SM, Barnes D, Kaplowitz G, Bloom I, Sabti M, Moore PA, Lee S, Meharry M, He DY, Li Y. Double-masked, randomized, placebo-controlled study to evaluate the efficacy and tolerability of intranasal K305 (3% tetracaine plus 0.05% oxymetazoline) in anesthetizing maxillary teeth. J Am Dent Assoc. 2016 Apr;147(4):278-87. doi: 10.1016/j.adaj.2015.12.008. Epub 2016 Jan 25.
PubMed 26822100Kanaa MD, Whitworth JM, Meechan JG. A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. J Endod. 2012 Mar;38(3):279-82. doi: 10.1016/j.joen.2011.11.010. Epub 2011 Dec 22.
PubMed 22341059Kanaa MD, Whitworth JM, Meechan JG. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod. 2012 Apr;38(4):421-5. doi: 10.1016/j.joen.2011.12.006. Epub 2012 Feb 2.
PubMed 22414822
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety of Primary Maxillary Second Molars Anesthesia Using Nasal Spray in Children
- ClinicalTrials.gov ID
- NCT03140787
- Acronym / sponsor ID
- UDDS-Pedo-01-2017
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 4 May 2017 (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.
68 healthy children from the Department of Pediatric Dentistry at Damascus University who require treatment for their primary maxillary second molars will be randomly assigned into one of two groups: experimental or control groups. In the experimental group, a lidocaine hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper second molar before the commencement of treatment.
To assess the efficacy of this kind of anesthesia, a specific scale will be used by an external observer after capturing some video files of the performed treatment.
To assess the safety of this procedure, vital signs will be recorded before and after treatment.
Acceptance of the nasal spray will be recorded based on the child's behavior before and after treatment using Frankl scale.
If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2% with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and acceptance will be assessed in the same manner to what is performed in the experimental group.
Detailed description
The most common method for anesthetizing maxillary teeth is infiltration injection of an anesthetic agent. This approach carries several disadvantages. First is the child's fear of pain. Infection is also a risk for providers, through exposure to blood-borne pathogens via needle stick.
Fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist.
Importantly, patients' fear of injections can delay needed dental care. Surveys indicate that 30-40 million people in the US avoid going to the dentist because of fear of pain and anesthetic injections.
Therefore an anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a "shot," would greatly benefit dental patients. Further, for procedures involving more than one maxillary tooth on the same side, a trans-nasally applied anesthetic agent that could anesthetize multiple maxillary teeth at once instead of use of repeated infiltration injections would be a major convenience for patients and dentists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Spray of Lidocaine HCL | Experimental | Drug: Nasal Spray of Lidocaine HCLThis group will receive treatment with an application of nasal spray for anesthetization. |
| Infiltration injection of Lidocaine HCL | Active comparator | Drug: Infiltration injection of Lidocaine HCLEach patient in this group will receive an infiltration injection for anesthetization |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children between 7-10 years.
- With a need for pulpotomy or a restorative dental procedure requiring local anesthesia for a single vital primary maxillary second molar with no evidence of pulpal necrosis.
- Normal lip, nose, eyelid, and cheek sensation.
- No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride.
Key exclusion criteria (4 listed)
- Frequent bleeding form the nose (≥ 5 per month)
- Inadequately controlled active thyroid disease of any type.
- Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
- History of allergy to or intolerance of lidocaine or epinephrine.
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 |
|---|---|---|
| Nasal Spray of Lidocaine HCLThis spray consists of lidocaine hydrochloride-epinephrine hydrochloride | Drug | Nasal Spray of Lidocaine HCL |
| Infiltration injection of Lidocaine HCLThis is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries. | Drug | Infiltration injection of Lidocaine HCL |
Primary outcome
Change in Blood Pressure
Time frame: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Systolic and diastolic blood pressure will be measured.
Change in Oxygen Saturation
Time frame: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Oxygen saturation will be measured using a specific device.
Change in Respiration Rate
Time frame: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Respiration rate will be measured clinically in the conventional manner.
Change in Heart Pulse Rate
Time frame: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.
Heart pulse rate will be measured clinically in the conventional manner.
Change in FLACC scale
Time frame: (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20
This scale will be used to evaluate efficacy. It will be studied by an external observer at 5 stages; first stage: during administration of the drug, second stage: while probing the gingiva around the tooth "buccally, palatally", third stage: when penetration of the dentino-enamel junction occurs, fourth stage: when exposure of the dental pulp occurs, fifth stage: during the removal of the coronal pulp.
Change in Frankl scale
Time frame: (1) within the first minute of drug administration, (2) when probing the gingiva at approx. Minute 5, (3) when entering the dentin at approx. Minute 10, (4) when exposing the pulp at approx. Minute 15, (5) during the removal of the pulp at Minute 20
This scale will be used to evaluate children's acceptance and will be measured by an external observer at five assessment times.
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 27 Jul 2017.
- Background: PubMed 23690356Ciancio SG, Hutcheson MC, Ayoub F, Pantera EA Jr, Pantera CT, Garlapo DA, Sobieraj BD, Almubarak SA. Safety and efficacy of a novel nasal spray for maxillary dental anesthesia. J Dent Res. 2013 Jul;92(7 Suppl):43S-8S. doi: 10.1177/0022034513484334. Epub 2013 May 20.
- Background: PubMed 23050753Reed KL, Malamed SF, Fonner AM. Local anesthesia part 2: technical considerations. Anesth Prog. 2012 Fall;59(3):127-36; quiz 137. doi: 10.2344/0003-3006-59.3.127.
- Background: PubMed 22900449Pandey RK, Bahetwar SK, Saksena AK, Chandra G. A comparative evaluation of drops versus atomized administration of intranasal ketamine for the procedural sedation of young uncooperative pediatric dental patients: a prospective crossover trial. J Clin Pediatr Dent. 2011 Fall;36(1):79-84. doi: 10.17796/jcpd.36.1.1774746504g28656.
- Background: PubMed 26822100Hersh EV, Pinto A, Saraghi M, Saleh N, Pulaski L, Gordon SM, Barnes D, Kaplowitz G, Bloom I, Sabti M, Moore PA, Lee S, Meharry M, He DY, Li Y. Double-masked, randomized, placebo-controlled study to evaluate the efficacy and tolerability of intranasal K305 (3% tetracaine plus 0.05% oxymetazoline) in anesthetizing maxillary teeth. J Am Dent Assoc. 2016 Apr;147(4):278-87. doi: 10.1016/j.adaj.2015.12.008. Epub 2016 Jan 25.
- Background: PubMed 22341059Kanaa MD, Whitworth JM, Meechan JG. A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. J Endod. 2012 Mar;38(3):279-82. doi: 10.1016/j.joen.2011.11.010. Epub 2011 Dec 22.
- Background: PubMed 22414822Kanaa MD, Whitworth JM, Meechan JG. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod. 2012 Apr;38(4):421-5. doi: 10.1016/j.joen.2011.12.006. Epub 2012 Feb 2.
- Individual participant dataSharing planned: No
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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.
Mohammad Raslan Alzein, DDS principal investigator
MSc student, Department of Paedodontics, University of Damascus Dental School
Shadi Azzawi, DDS MSc PhD study director
Senior Lecturer in Paedodontics, Department of Paedodontics, University of Damascus Dental School, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Spray of Lidocaine HCL and Infiltration injection of Lidocaine HCL in people with Dental Caries, run by Damascus University at 1 site in Syria.
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 27 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 Syria. 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?
Change in Blood Pressure (time frame: (1) five minutes before drug administration, (2) after 10 minutes of anesthesia, and (3) at the completion of the dental treatment, an average of 40 minutes.). The study lists 6 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 NCT03140787, which also lists 6 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 27 Jul 2017.