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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02601924
Enrollment
80
Registered
2015-11-11
Start date
2016-02-29
Completion date
2018-04-30
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pulp/ Pulpitis

Keywords

Anesthesia, injection, pain, pressure massage, topical gel

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: 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.

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.

Interventions

OTHERTopical pressure massage

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

DRUG20% Benzocain (Master-Dent, Monroe, NC)

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

Sponsors

Kerman University of Medical Sciences
CollaboratorOTHER
Nahid Mohammadzadeh Akhlaghi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Pain rate using Visual Analog Scale(VAS)2 minutesTopical anesthetic gel / pressure massage will be applied at the site of injection for 1 minute and anesthetic solution will be done during 1 minute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026