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Investigating the effect of needle entry angle on the amount of pain during premaxilla labial infiltration injection in patients referred to the special oral and maxillofacial surgery

Investigating the effect of needle entry angle on the amount of pain during premaxilla labial infiltration injection in patients referred to the special oral and maxillofacial surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230719058849N1
Enrollment
36
Registered
2023-07-31
Start date
2023-08-23
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

This study is not done on specific patients. Only the amount of pain after different injection techniques will be investigated and compared..

Interventions

Intervention 1: Intervention group: Group A: injection of labial infiltration in the anterior of the maxilla parallel to the longitudinal axis of the tooth with a normal syringe - in this group anesth

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy individuals (ASA 1 & ASA 2 based on American society of anesthesiologist classification) who are healthy in terms of written records (based on the individual's records in their medical record) and oral question (interview). The GHQ-28 general health questionnaire (available in the appendix) is used to equalize the participants psychologically. The validity and reliability of the questionnaire in Persian version is confirmed. Participants should not take any medication that alters their perception of pain. All participants have healthy systemic conditions and no active infection in the injection area. Individuals are volunteers to participate in the study. Candidates must be 20 to 60 years old.

Exclusion criteria

Exclusion criteria: Individuals who take drugs that change their perception of pain. Individuals who have an active infection in the injection area. Patients with cardiovascular, respiratory and blood pressure (over 15) diseases.

Design outcomes

Primary

MeasureTime frame
The amount of pain after injection. Timepoint: Immediately after injection. Method of measurement: Using a numerical rating scale (NRS 0-10), the pain level is evaluated. This scale has points from 0 to 10 and the patient is asked to specify the level of pain in the index [61].

Secondary

MeasureTime frame
Blood pressure. Timepoint: Before, during and after injection. Method of measurement: When the patient sits on the dental chair, we wait 10 minutes until the patient's heart rate, blood pressure, and respiratory rate return to normal. Then the vital sign device (CMS 6000 brand made in China) is connected to the patient to measure heart rate, blood pressure and respiratory rate and the patient is monitored. For adults, normal blood pressure is defined as 120/80 (mmHg). After the patient is connected to the vital sign measuring device, blood pressure is recorded before the injection. Then once during the injection and finally immediately after the injection blood pressure is recorded and compared with the initial level.;Heart beat. Timepoint: Before, during and after injection. Method of measurement: When the patient sits on the dental chair, we wait 10 minutes until the patient's heart rate, blood pressure, and respiratory rate return to normal. Then the vital sign device (CMS 6000 brand made in China) is connected to the patient to measure heart rate, blood pressure and respiratory rate and the patient is monitored. For adults, a normal heart rate is defined as 80 to 100 beats per minute (bpm). After the patient is connected to the vital sign measuring device, the heart rate is recorded before the injection. Then, once during the injection and finally immediately after the injection, the heart rate is recorded and compared with the initial rate.;Respiratory rate. Timepoint: Before, during and after injection. Method of measurement: When the patient sits on the dental chair, we wait 10 minutes until the patient's heart rate, blood pressure, and respiratory rate return to normal. Then the vital sign device (CMS 6000 brand made in China) is connected to the patient to measure heart rate, blood pressure and respiratory rate and the patient is monitored. For adults, normal breathing is defined as 12 to 20 breaths per minute. After the patient is connected to the vital si

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Moaddabi

Mazandaran University of Medical Sciences

a.moaddabi2@gmail.com+98 11 3324 4894

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026