Dental Caries Clinical Trial
Official title:
Assessment of Efficacy and Safety of Primary Maxillary Second Molars Anesthesia Using Nasal Spray in Children
Verified date | July 2017 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | June 15, 2017 |
Est. primary completion date | May 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 10 Years |
Eligibility |
Inclusion Criteria: 1. Healthy children between 7-10 years. 2. 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. 3. Normal lip, nose, eyelid, and cheek sensation. 4. No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride. Exclusion Criteria: 1. Frequent bleeding form the nose (= 5 per month) 2. Inadequately controlled active thyroid disease of any type. 3. Having received dental care requiring a local anesthetic within the 24 hours preceding study entry. 4. History of allergy to or intolerance of lidocaine or epinephrine. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Department of Peadodontics, University of Damascus Dental School | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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. — View Citation
Hersh 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. — View Citation
Kanaa 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. — View Citation
Kanaa 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. — View Citation
Pandey 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. — View Citation
Reed 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Blood Pressure | Systolic and diastolic blood pressure will be 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. | |
Primary | Change in Oxygen Saturation | Oxygen saturation will be measured using a specific device. | (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. | |
Primary | Change in Respiration Rate | Respiration rate will be measured clinically in the conventional manner. | (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. | |
Primary | Change in Heart Pulse Rate | Heart pulse rate will be measured clinically in the conventional manner. | (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. | |
Primary | 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. | (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 | |
Primary | 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. | (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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04127929 -
Investigation of Glass Carbomer Performance
|
N/A | |
Completed |
NCT04769882 -
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
|
N/A | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Active, not recruiting |
NCT04475679 -
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
|
N/A | |
Completed |
NCT05438381 -
Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars
|
N/A | |
Not yet recruiting |
NCT03037814 -
Clinical Performance of Restorative Materials in Primary Teeth
|
N/A | |
Active, not recruiting |
NCT05202665 -
Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion
|
N/A | |
Terminated |
NCT01147835 -
Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
|
N/A | |
Not yet recruiting |
NCT04033263 -
Maintaining Oral Health With Bio-products
|
N/A | |
Enrolling by invitation |
NCT04438252 -
Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions
|
N/A | |
Not yet recruiting |
NCT03609034 -
Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
|
||
Completed |
NCT02912000 -
TEACH: Technology Evaluation to Address Child Health
|
N/A | |
Completed |
NCT02473107 -
Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
|
N/A | |
Active, not recruiting |
NCT02537184 -
Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children
|
N/A | |
Completed |
NCT01950546 -
Nanosilver Fluoride to Prevent Dental Biofilms Growth
|
Phase 1 | |
Recruiting |
NCT02734420 -
Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial
|
Phase 1 | |
Completed |
NCT02020681 -
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
|
N/A | |
Completed |
NCT02426619 -
Arresting Active Dental Caries in Preschool Children by Topical Fluorides
|
Phase 2/Phase 3 | |
Completed |
NCT02234609 -
Effectiveness of Modified Class IV Atraumatic Restorative Treatment
|
N/A | |
Withdrawn |
NCT01224002 -
A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
|
N/A |