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

NCT ID: NCT02601924

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-04-30

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.

Conditions

Normal Pulp/ Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Topical Pressure Massage Block injection

Topical pressure massage at site of alveolar nerve block injection.

Group Type: ACTIVE_COMPARATOR

Topical pressure massage

Intervention Type: OTHER

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

Topical Anesthetic Gel Block injection

Topical anesthetic gel (20% Benzocain) at site of inferior alveolar nerve block injection.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Topical Pressure Massage Infiltration

Topical pressure massage at site of maxillary anterior infiltration

Group Type: ACTIVE_COMPARATOR

Topical pressure massage

Intervention Type: OTHER

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

Topical Anesthetic Gel Infiltration

Topical anesthetic gel (20% Benzocain) at site of maxillary anterior infiltration

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Topical pressure massage

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

Intervention Type: OTHER

Other Intervention Names

Topical anesthetic 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kerman University of Medical Sciences

OTHER

Sponsor Role: collaborator

Nahid Mohammadzadeh Akhlaghi

OTHER

Sponsor Role: lead

Responsible Party

Nahid Mohammadzadeh Akhlaghi

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

KMU 1394.215

Identifier Type: -

Identifier Source: org_study_id