Efficacy of Pressure Massage and Topical Gel on Pain During Intra Oral Injections

January 12, 2019 updated by: Nahid Mohammadzadeh Akhlaghi

Efficacy of Pressure Massage and Topical Gel on Pain During Inferior Alveolar Nerve Block and Maxillary Anterior Injections: A Single-Blind Randomized Clinical Trial

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:

  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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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 (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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topical Pressure Massage Block injection
Topical pressure massage at site of alveolar nerve block injection.
Other: Topical pressure massage
Two topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection.
Active Comparator: Topical Anesthetic Gel Block injection
Topical anesthetic gel (20% Benzocain) at site of inferior alveolar nerve block injection.
Drug: 20% Benzocain (Master-Dent, Monroe, NC)
Two topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth.
Other Names:
  • Topical anesthetic gel
Active Comparator: Topical Pressure Massage Infiltration
Topical pressure massage at site of maxillary anterior infiltration
Other: Topical pressure massage
Two topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection.
Active Comparator: Topical Anesthetic Gel Infiltration
Topical anesthetic gel (20% Benzocain) at site of maxillary anterior infiltration
Drug: 20% Benzocain (Master-Dent, Monroe, NC)
Two topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth.
Other Names:
  • Topical anesthetic gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain rate using Visual Analog Scale(VAS)
Time Frame: 2 minutes
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
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nahid Mohammadzadeh Akhlaghi

Collaborators

Kerman University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 7, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 12, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU 1394.215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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