Normal Pulp/ PulpitisPhase 2NCT02601924
Efficacy of Pressure Massage and Topical Gel on Pain During Intra Oral Injections
A Phase 2 study testing 20% Benzocain (Master-Dent, Monroe, NC) and Topical pressure massage in people with Normal Pulp/ Pulpitis, run by Nahid Mohammadzadeh Akhlaghi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Pulp/ Pulpitis
- What is being tested?
- 20% Benzocain (Master-Dent, Monroe, NC) and Topical pressure massage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
About this study
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
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.
Read the 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.
- Conditions
- Normal Pulp/ Pulpitis
- Being tested
- 20% Benzocain (Master-Dent, Monroe, NC), Topical pressure massage
- Keywords
- Anesthesia, injection, pain, pressure massage, topical gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% Benzocain (Master-Dent, Monroe, NC)Drug
Also called Topical anesthetic gel
Two topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth.
Topical pressure massageOther
Two topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection.
| Study group | Role | What they receive |
|---|---|---|
| Topical Pressure Massage Block injection | Active comparator | Topical pressure massage at site of alveolar nerve block injection. Receives: Other: Topical pressure massage |
| Topical Anesthetic Gel Block injection | Active comparator | Topical anesthetic gel (20% Benzocain) at site of inferior alveolar nerve block injection. Receives: Drug: 20% Benzocain (Master-Dent, Monroe, NC) |
| Topical Pressure Massage Infiltration | Active comparator | Topical pressure massage at site of maxillary anterior infiltration Receives: Other: Topical pressure massage |
| Topical Anesthetic Gel Infiltration | Active comparator | Topical anesthetic gel (20% Benzocain) at site of maxillary anterior infiltration Receives: Drug: 20% Benzocain (Master-Dent, Monroe, NC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pulp/ PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nahid Mohammadzadeh Akhlaghi
- Sponsor type
- University, hospital or other
- Collaborators
- Kerman University of Medical Sciences
- Responsible party
- Sponsor-investigator, Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601924
- Sponsor's protocol ID
- KMU 1394.215
- Status last verified
- Jan 2019
- First submitted
- 7 Nov 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02601924
- Acronym / sponsor ID
- KMU 1394.215
- Conditions
- Normal Pulp/ Pulpitis
- Keywords
- Anesthesia, injection, pain, pressure massage, topical gel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nahid Mohammadzadeh AkhlaghiUniversity, hospital or other
- Collaborators
- Kerman University of Medical Sciences
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Topical Pressure Massage Block injection | Active comparator | Other: Topical pressure massageTopical pressure massage at site of alveolar nerve block injection. |
| Topical Anesthetic Gel Block injection | Active comparator | Drug: 20% Benzocain (Master-Dent, Monroe, NC)Topical anesthetic gel (20% Benzocain) at site of inferior alveolar nerve block injection. |
| Topical Pressure Massage Infiltration | Active comparator | Other: Topical pressure massageTopical pressure massage at site of maxillary anterior infiltration |
| Topical Anesthetic Gel Infiltration | Active comparator | Drug: 20% Benzocain (Master-Dent, Monroe, NC)Topical anesthetic gel (20% Benzocain) at site of maxillary anterior infiltration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20% Benzocain (Master-Dent, Monroe, NC)Also: Topical anesthetic gelTwo topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth. | Drug | Topical Anesthetic Gel Block injection, Topical Anesthetic Gel Infiltration |
| Topical pressure massageTwo topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection. | Other | Topical Pressure Massage Block injection, Topical Pressure Massage Infiltration |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 20% Benzocain (Master-Dent, Monroe, NC) and Topical pressure massage in people with Normal Pulp/ Pulpitis, run by Nahid Mohammadzadeh Akhlaghi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain rate using Visual Analog Scale(VAS) (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.