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

NCT02601924 | Completed Phase 2 DMC

• 1 other identifier: KMU 1394.215
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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. 1.Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)
2. 2.Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB
3. 3.Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)
4. 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.

Conditions

Normal Pulp/ Pulpitis

Keywords

Anesthesia; injection; pain; pressure massage; topical gel

Outcome Measures

Primary Outcomes (1)

• 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

  2 minutes

Study Arms (4)

Topical Pressure Massage Block injection

ACTIVE COMPARATOR

Topical pressure massage at site of alveolar nerve block injection.

Other: Topical pressure massage

Topical Anesthetic Gel Block injection

ACTIVE COMPARATOR

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

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

Topical Pressure Massage Infiltration

ACTIVE COMPARATOR

Topical pressure massage at site of maxillary anterior infiltration

Other: Topical pressure massage

Topical Anesthetic Gel Infiltration

ACTIVE COMPARATOR

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

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

Interventions

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.

Also known as: Topical anesthetic gel

Topical Anesthetic Gel Block injection; Topical Anesthetic Gel Infiltration

Topical pressure massage OTHER

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

Topical Pressure Massage Block injection; Topical Pressure Massage Infiltration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Nahid Mohammadzadeh Akhlaghi: lead
• Kerman University of Medical Sciences: collaborator

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 11, 2015
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01