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How Successful is Supplemental Intraseptal Anaesthesia in Patients With Mandibular Teeth Extraction or Irreversible Pulpitis

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ClinicalTrials.gov Identifier: NCT03880409
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Giath Gazal, Taibah University

Brief Summary:

Introduction:

Local anesthetic failure is an unavoidable aspect of dental practice. A number of factors contribute to this, which may be related to either the patient or the operator. Patient-dependent factors may be anatomical, pathological or psychological1-3. Work is still going on by dental clinicians and researchers in order to find an optimal local anesthetic agent which it has a high potency and rapid onset of action.4-6. However, pain free injection also play a role in improving the patient perceptions toward the dentist and dental treatments and encouraging patients to attend a regular checkup5-8.

Failure of the local anaesthetic injections using Inferior Alveolar Nerve Block (IANB) for lower teeth in asymptomatic and symptomatic patients requires additional buck-up strategies to achieve pain free dental treatment. Otherwise, the patient complains of severe pain and hindering the clinician to proceed to the dental treatment.

Mechanism of action for intraseptal injection The route of diffusion and distribution of the anaesthetic solution in the intraseptal technique is most likely through the medullary bone (Fig. 1). It offers anaesthesia to the bone, delicate/soft tissues, root structure in the region of infusion. It is best when both pain control and haemostasis are wanted for delicate /soft tissue and bony periodontal treatment.

Figure 1: Represents the point of needle insertion for the Intraseptal Injection and the position of the needle 3mm apical to the apex of the papillary triangle5.

Advantages of intraseptal injection In contrast to IANB and local infiltration, the intraseptal technique prevents the anaesthesia of tissues such as lips and tongue hence, decreases the chances of cheek or lip biting (self-trauma). It necessitates minimum or least dosage of local anaesthetic and minimizes bleeding during the surgical procedure. This technique being less traumatic, has immediate or instantaneous (<30-sec) onset of action and comparatively less number of postsurgical complications14. Intravascular injection is extremely unlikely to occur15compared to IANB or infiltration. Assertions that intraseptal anaesthesia is immediate are properly consistent with previous clinical results. Their findings reported that the onset of action for anaesthesia was within one minute after injection. So the onset time can be considered rapid if not immediate.

Disadvantages of intraseptal Injection Clinical experience and multiple tissue punctures may be necessary to perform this technique. During the anaesthetic procedure, the anaesthetic solution may leak in to the oral cavity resulting discomfort and an unpleasant or bitter taste. The effective period anaesthesia for pulpal and soft-tissues is very limited20 hence multiple repeats may be required for longer surgical procedures.

The aim of this prospective clinical study is to determine the anesthetic efficacy of the supplemental intraseptal technique in mandibular teeth diagnosed with extraction when the conventional inferior alveolar


Condition or disease Intervention/treatment Phase
Overcoming the Failure of Anesthesia in the Mandibular Teeth Drug: 2% lidocaine with 1:000,000 epinephrine Drug: 4% articaine with 1:000,000 epinephrine Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: How Successful is Supplemental Intraseptal Anaesthesia in Patients With Mandibular Teeth Extraction or Irreversible Pulpitis
Estimated Study Start Date : April 9, 2019
Estimated Primary Completion Date : July 3, 2019
Estimated Study Completion Date : July 30, 2019


Arm Intervention/treatment
Active Comparator: 2% lidocaine with 1:000,000 epinephrine
supplemental intraseptal injections using 0.8 mL 2% lidocaine with 1:000,000 epinephrine
Drug: 2% lidocaine with 1:000,000 epinephrine
2% lidocaine with 1:000,000 epinephrine is dental local anesthesia

Active Comparator: 4% articaine with 1:000,000 epinephrine
buccal infiltration of 1.8 ml 4% articaine with 1:000,000 epinephrine
Drug: 2% lidocaine with 1:000,000 epinephrine
2% lidocaine with 1:000,000 epinephrine is dental local anesthesia

Drug: 4% articaine with 1:000,000 epinephrine
4% articaine with 1:000,000 epinephrine is dental local anesthesia




Primary Outcome Measures :
  1. Assessment the success of inferior alveolar nerve block during the extraction of mandible teeth will be assessed by using a 170-mm Heft-Parker visual analog scale (VAS) [ Time Frame: 6 months ]
    The success of the IAN block will be defined as the ability to carry on the tooth extraction with no or mild pain (VAS score of 0 or ≤ 54 mm, respectively).


Secondary Outcome Measures :
  1. assessment of Injection discomfort [ Time Frame: 6 months ]
    The discomfort of the injections will be recorded by the patients following IAN block and intraseptal injections on standard 100mm visual analogue scales (VAS), tagged at the endpoints with "no pain" (0 mm) and "unbearable pain" (100 mm).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-70 years of age,
  • In good health (American Society of Anesthesiologists classification I or II) and
  • Having one non-surgical tooth for extraction.

Exclusion Criteria:

  • Allergy to local anesthetics,
  • History of significant medical problems (American Society of Anesthesiologists classification III or greater),
  • Having recently taken central nervous system depressants (including alcohol or any analgesic medications within 6 hours before treatment),
  • Pregnancy, lactating, or
  • Inability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880409


Contacts
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Contact: Giath Gazal, PhD 00966532158597 gazal73@yahoo.co.uk
Contact: Mahmod Alkayyal, BDS m.alkayyal94@hotmail.com

Locations
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Saudi Arabia
Taibah University Recruiting
Medina, Saudi Arabia, 41311
Contact: Giath Gazal, PhD         
Sponsors and Collaborators
Taibah University

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Responsible Party: Giath Gazal, Associate Professor, Taibah University
ClinicalTrials.gov Identifier: NCT03880409     History of Changes
Other Study ID Numbers: IRB#00010037
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Lidocaine
Carticaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics