Efficacy of Pressure Massage and Topical Gel on Pain During Inferior Alveolar Nerve Block and Maxillary Anterior Injections.A prospective, randomized, double-blind, clinical trial study.
Aim: This study aimed to evaluate the efficacy of topical pressure massage and anesthetic gel on pain of dental injections. Design: In this double-blind, prospective, randomized clinical trial, eighty healthy volunteers will be participated. Methods: All the patients who have including criteria and have a mandibular premolar/molar or a maxillary anterior tooth with the diagnosis of normal pulp, reversible pulpitis or asymptomatic irreversible pulpitis will receive an injection in one of the following groups according to the random number table:
1. Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)
2. Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB
3. Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)
4. Group TGI: Topical gel with a MAI
All the injections will be performed using an aspirating syringes containing 1.8 ml of lidocaine with 1:80000 epinephrine (2%Persocaine_E; Darupakhsh, Tehran, Iran) and 28-guage needles by a single operator. Immediately after the injection, patients will be asked to record the amount of pain they felt during needle penetration and injection using visual analog scal(VAS) form. Only the first injection will be subjected to the evaluation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111916845N5
Registration date:2015-12-11, 1394/09/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Nahid Akhlaghi
Name of organization / entity
Tehran Dental Branch Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2201 1751
Email address
n_akhlaghi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2015-09-20, 1394/06/29
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Pressure Massage and Topical Gel on Pain During Inferior Alveolar Nerve Block and Maxillary Anterior Injections.A prospective, randomized, double-blind, clinical trial study.
Public title
Efficacy of Pressure Massage and Topical Gel on Pain During Intra Oral Injections
Purpose
Prevention
Inclusion/Exclusion criteria
Patients ranged18-65 years old; No systemic disease; Non pregnant or beast feeding; A mandibular premolar/molar or a maxillary anterior tooth with the diagnosis of
normal pulp, reversible pulpitis or asymptomatic irreversible pulpitis (Heft Parker
visual analogue scale ≤ 54); Need dental treatment; Not taking analgesics, sedative or anti-anxiety medication during the last 24 hours; No intra oral injection at the treatment area during the last 24 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02601924
Registration date
1394-08-23, 777/01/-1304
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Jomhouri Blvd
City
Kerman
Postal code
Approval date
2015-07-13, 1394/04/22
Ethics committee reference number
ir.kum.1394.215
Health conditions studied
1
Description of health condition studied
reversible/Irreversible pulpitis
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
Pain during dental injection
Timepoint
2 minutes
Method of measurement
Pain rate using Visual Analog Scale(VAS) form
Secondary outcomes
empty
Intervention groups
1
Description
Topical Anesthetic Gel for Inferior Alveolar Nerve Block injection
Category
Prevention
2
Description
Topical Anesthetic Gel Maxillary Anterior Infiltration