Efficacy of Pressure Massage and Topical Gel on Pain During Intra Oral Injections
Primary Purpose
Normal Pulp/ Pulpitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
20% Benzocain (Master-Dent, Monroe, NC)
Topical pressure massage
Sponsored by
About this trial
This is an interventional prevention trial for Normal Pulp/ Pulpitis focused on measuring Anesthesia, injection, pain, pressure massage, topical gel
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Topical Pressure Massage Block injection
Topical Anesthetic Gel Block injection
Topical Pressure Massage Infiltration
Topical Anesthetic Gel Infiltration
Arm Description
Topical pressure massage at site of alveolar nerve block injection.
Topical anesthetic gel (20% Benzocain) at site of inferior alveolar nerve block injection.
Topical pressure massage at site of maxillary anterior infiltration
Topical anesthetic gel (20% Benzocain) at site of maxillary anterior infiltration
Outcomes
Primary Outcome Measures
Pain rate using Visual Analog Scale(VAS)
Topical anesthetic gel / pressure massage will be applied at the site of injection for 1 minute and anesthetic solution will be done during 1 minute
Secondary Outcome Measures
Full Information
NCT ID
NCT02601924
First Posted
November 7, 2015
Last Updated
January 12, 2019
Sponsor
Nahid Mohammadzadeh Akhlaghi
Collaborators
Kerman University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02601924
Brief Title
Efficacy of Pressure Massage and Topical Gel on Pain During Intra Oral Injections
Official Title
Efficacy of Pressure Massage and Topical Gel on Pain During Inferior Alveolar Nerve Block and Maxillary Anterior Injections: A Single-Blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nahid Mohammadzadeh Akhlaghi
Collaborators
Kerman University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Eighty patients with inclusion criteria will participate in this studyEach patient will receive an injection in one of the following groups according to the random number table:
Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)
Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB
Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)
Group TGI: Topical gel with a MAI. Immediately after the injection, patients will be asked to record the amount of pain they felt during needle penetration and injection using VAS form.Data will be analyzed using ANOVA and t-test.
Detailed Description
Eighty patients will be requested to take participate in this study after signing a written consent form. The inclusion criteria for the participants are as follows: 18-65 years old, having no systemic disease, not pregnant or beast feeding, having a mandibular premolar/molar or a maxillary anterior tooth with the diagnosis of normal pulp, reversible pulpitis or asymptomatic irreversible pulpitis (no or mild tenderness to percussion, normal periapical radiographic appearance), not taking analgesics, sedative or anti-anxiety medication and no intra oral injection at the treatment area, during the last 24 hours. By using a 170 mm Visual Analogue Scale (VAS), patients with pain less than or equal to 54 are classified as having asymptomatic irreversible pulpitis. The way to use the VAS will be explained to the patients prior to the procedure.
Each patient will receive an injection in one of the following groups according to the random number table:
Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)
Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB
Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)
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 (N.M.A). Immediately after the injection, patients will be asked to record the amount of pain they felt during needle penetration and injection using VAS form. If the patient is subjected to more than one injection during the root canal treatment, only the first injection will be subjected to the evaluation. Recording of the acquired data from the VAS forms will be done by another operator (P.M) who will be unaware of the patients' categorization.
Data will be analyzed using ANOVA and t-test with the significance level of p<0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pulp/ Pulpitis
Keywords
Anesthesia, injection, pain, pressure massage, topical gel
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Pressure Massage Block injection
Arm Type
Active Comparator
Arm Description
Topical pressure massage at site of alveolar nerve block injection.
Arm Title
Topical Anesthetic Gel Block injection
Arm Type
Active Comparator
Arm Description
Topical anesthetic gel (20% Benzocain) at site of inferior alveolar nerve block injection.
Arm Title
Topical Pressure Massage Infiltration
Arm Type
Active Comparator
Arm Description
Topical pressure massage at site of maxillary anterior infiltration
Arm Title
Topical Anesthetic Gel Infiltration
Arm Type
Active Comparator
Arm Description
Topical anesthetic gel (20% Benzocain) at site of maxillary anterior infiltration
Intervention Type
Drug
Intervention Name(s)
20% Benzocain (Master-Dent, Monroe, NC)
Other Intervention Name(s)
Topical anesthetic gel
Intervention Description
Two topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth.
Intervention Type
Other
Intervention Name(s)
Topical pressure massage
Intervention Description
Two topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection.
Primary Outcome Measure Information:
Title
Pain rate using Visual Analog Scale(VAS)
Description
Topical anesthetic gel / pressure massage will be applied at the site of injection for 1 minute and anesthetic solution will be done during 1 minute
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
-
12. IPD Sharing Statement
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Efficacy of Pressure Massage and Topical Gel on Pain During Intra Oral Injections
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