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Completed

NCT Number: NCT02601924

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

20% Benzocain (Master-Dent, Monroe, NC)

Drug

Two topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth.

Other names: Topical anesthetic gel

Topical pressure massage

Other

Two topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nahid Mohammadzadeh Akhlaghi

Other

Collaborators

  • Kerman University of Medical Sciences

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 11, 2015
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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