Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System

NCT04392804 | Unknown DMC

• 1 other identifier: UBelgrade 36/8
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. In addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the ISA achieved by 4% articaine with 1:100,000 epinephrine, using CCLAD system.

Conditions

Anesthesia, Local; Periodontitis

Keywords

intraseptal anesthesia; ISA; CCLADS

Outcome Measures

Primary Outcomes (9)

• Number of success anesthesia

  The number of success anesthesia

  1 day

• Duration of soft tissue anesthesia

  Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.

  1 day

• Width of the anesthetic field

  Distance between two needles that were not causing pain on pinprick test, measured in millimeters.

  1 day

• Onset time for anesthesia

  Time started after completion of the injection until profound anesthesia is establish, measured in seconds.

  1 day

• Rate of pain during anesthetic delivery by VAS

  Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is labeled for the minimum feel of pain or no pain, and 100 is labeled for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.

  1 day

• Rate of pain during scaling and root planing by VAS

  Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is score for the minimum feel of pain or no pain, and 100 is score for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.

  1 day

• Presence of side effects

  Record any side effects.

  1 day

• Analgesic medication consumption

  Record number of analgesic medications.

  1 day

• Wich day analgesic medication is used

  Wich day from intervention a analgesic medication is used

  7 days

Secondary Outcomes (5)

• Pocket probing depths

  1 day

• Gingival margin level

  1 day

• Clinical attachment level

  1 day

• Percentage of bleeding sites

  1 day

• Percentage of plaque index

  1 day

Study Arms (3)

0.1 ml 4% articaine

single dose of 0.1 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing

Procedure: scaling and root planing

0.2 ml 4% articaine

single dose of 0.2 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing

Procedure: scaling and root planing

0.3 ml 4% articaine

single dose of 0.3 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing

Procedure: scaling and root planing

Interventions

scaling and root planing PROCEDURE

one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution

0.1 ml 4% articaine; 0.2 ml 4% articaine; 0.3 ml 4% articaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Systemically healthy periodontitis patients having the indication for scaling and root planing.

You may qualify if:

• age ≥ 18 years
• confirmed diagnosis of periodontitis
• presence of minimum 20 teeth
• absence of decay
• preserved tooth vitality
• good systematic health

You may not qualify if:

• allergy to articaine with 1: 100,000 epinephrine
• pregnancy
• lactation
• medication uptake that affects the periodontal supporting tissues
• acute pain, swelling, presence of gingival lesions

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (2)

• Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Patient discomfort and intensity of intraseptal anesthesia of computer-controlled articaine/epinephrine delivery for scaling and root planing. Clin Oral Investig. 2023 Oct;27(10):6221-6234. doi: 10.1007/s00784-023-05238-1. Epub 2023 Aug 29.

  PMID: 37644233 DERIVED

• Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Efficacy of intraseptal anesthesia obtained by computer-controlled articaine with epinephrine delivery in scaling and root planing. Clin Oral Investig. 2023 Jun;27(6):2913-2922. doi: 10.1007/s00784-023-04889-4. Epub 2023 Feb 6.

  PMID: 36746819 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, DDS, MSc, PhD

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 19, 2020
• Study Start: May 19, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)