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

NCT03880409 | Completed Phase 1

• 1 other identifier: IRB#00010037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Overcoming the Failure of Anesthesia in the Mandibular Teeth

Outcome Measures

Primary Outcomes (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)

  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).

  6 months

Secondary Outcomes (1)

• assessment of Injection discomfort

  6 months

Study Arms (2)

2% lidocaine with 1:000,000 epinephrine

ACTIVE COMPARATOR

supplemental intraseptal injections using 0.8 mL 2% lidocaine with 1:000,000 epinephrine

Drug: 2% lidocaine with 1:000,000 epinephrine

4% articaine with 1:000,000 epinephrine

ACTIVE COMPARATOR

buccal infiltration of 1.8 ml 4% articaine with 1:000,000 epinephrine

Drug: 2% lidocaine with 1:000,000 epinephrine; Drug: 4% articaine with 1:000,000 epinephrine

Interventions

2% lidocaine with 1:000,000 epinephrine DRUG

2% lidocaine with 1:000,000 epinephrine is dental local anesthesia

2% lidocaine with 1:000,000 epinephrine; 4% articaine with 1:000,000 epinephrine

4% articaine with 1:000,000 epinephrine DRUG

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

4% articaine with 1:000,000 epinephrine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taibah University: lead

Study Sites (1)

Taibah University

Madinah, 41311, Saudi Arabia

Location

MeSH Terms

Interventions

Lidocaine; Carticaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: February 9, 2019
• Primary Completion: September 3, 2019
• Study Completion: September 8, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)