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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
Nahid Mohammadzadeh Akhlaghi
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 7, 2015
    Last Updated
    January 12, 2019
    Sponsor
    Nahid Mohammadzadeh Akhlaghi
    Collaborators
    Kerman University of Medical Sciences
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    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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