Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment

NCT04563351 | Completed DMC

• 1 other identifier: BB 174/18
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare the effectiveness and complications of intraligamentary anesthesia (ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental treatment of mandibular posterior teeth. Materials and Methods: In this randomized, prospective clinical trial, 72 patients (39 males, 33 females) patients scheduled for dental treatment of mandibular posterior teeth, were randomly allocated to ILA group (n=35) received ILA injection or IANB group (n=37) received the conventional IANB. Our primary outcome was to assess pain during the injection as well as pain and stress (discomfort) during dental treatment, using the Numeric Rating Scale (NRS) from 0 to 10 (0 = no pain, 10= the worst pain imaginable). Whereas; recording 24 hours postoperative complications were our Secondary outcomes.

Conditions

Dental Caries

Keywords

local anesthetic; dentistry; pain; techniques

Outcome Measures

Primary Outcomes (3)

• The intensity of pain during the injection

  The intensity of pain during the injection of the LA to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.

  immediately after the injection of LA

• The intensity of pain during the dental treatment

  The intensity of pain during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.

  immediately after the dental treatment

• The intensity of stress (discomfort)

  The intensity of stress during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no discomfortable at all and 10 representing the maximal discomfortable very imaginable) is a valid instrument to measure stress (discomfort)

  immediately after the dental treatment

Secondary Outcomes (1)

• Postoperative complications

  24 hours

Study Arms (2)

conventional inferior alveolar nerve block (IANB)

ACTIVE COMPARATOR

37 patients received Inferior Alveolar Nerve Block (IANB) for dental treatment of mandibular posterior teeth.

Other: local anaesthetic techniques

Intraligamentary Anesthesia (ILA)

EXPERIMENTAL

35 patients received Intraligamentary Anesthesia (ILA) for dental treatment of mandibular posterior teeth.

Other: local anaesthetic techniques

Interventions

local anaesthetic techniques OTHER

The patients were anesthetized with two different local anaesthetic techniques.

Intraligamentary Anesthesia (ILA); conventional inferior alveolar nerve block (IANB)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia

You may not qualify if:

• Patients with a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology
• Patients with a systemic disease requiring special considerations during their dental treatment
• Patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite)

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine of Greifswald

Greifswald, 17487, Germany

Location

Related Publications (20)

• Pradhan R, Kulkarni D, Shetty L. Evaluation of Efficacy of Intraligamentary Injection Technique for Extraction of Mandibular Teeth-A Prospective Study. J Clin Diagn Res. 2017 Jan;11(1):ZC110-ZC113. doi: 10.7860/JCDR/2017/22204.9302. Epub 2017 Jan 1.

  PMID: 28274058 RESULT

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 RESULT

• Siegel K, Schrimshaw EW, Kunzel C, Wolfson NH, Moon-Howard J, Moats HL, Mitchell DA. Types of dental fear as barriers to dental care among African American adults with oral health symptoms in Harlem. J Health Care Poor Underserved. 2012 Aug;23(3):1294-309. doi: 10.1353/hpu.2012.0088.

  PMID: 24212175 RESULT

• Bahl R. Local anesthesia in dentistry. Anesth Prog. 2004;51(4):138-42. No abstract available.

  PMID: 15675263 RESULT

• Shabazfar N, Daublander M, Al-Nawas B, Kammerer PW. Periodontal intraligament injection as alternative to inferior alveolar nerve block--meta-analysis of the literature from 1979 to 2012. Clin Oral Investig. 2014;18(2):351-8. doi: 10.1007/s00784-013-1113-1. Epub 2013 Sep 29.

  PMID: 24077785 RESULT

• Kaufman E, Weinstein P, Milgrom P. Difficulties in achieving local anesthesia. J Am Dent Assoc. 1984 Feb;108(2):205-8. doi: 10.14219/jada.archive.1984.0470. No abstract available.

  PMID: 6584494 RESULT

• Pogrel MA. Permanent nerve damage from inferior alveolar nerve blocks--an update to include articaine. J Calif Dent Assoc. 2007 Apr;35(4):271-3.

  PMID: 17612365 RESULT

• Marniemi J, Parkki MG. Radiochemical assay of glutathione S-epoxide transferase and its enhancement by phenobarbital in rat liver in vivo. Biochem Pharmacol. 1975 Sep 1;24(17):1569-72. doi: 10.1016/0006-2952(75)90080-5. No abstract available.

  PMID: 9 RESULT

• Kämmerer PW, Palarie V, Schiegnitz E, Ziebart T, Al-Nawas B, Daubländer M. Clinical and histological comparison of pulp anesthesia and local diffusion after periodontal ligament injection and intrapapillary infiltration anaesthesia. J Pain Relief. 2012;1(10.4172):2167-0846.

  RESULT

• Walton RE, Garnick JJ. The periodontal ligament injection: histologic effects on the periodontium in monkeys. J Endod. 1982 Jan;8(1):22-6. doi: 10.1016/S0099-2399(82)80312-9. No abstract available.

  PMID: 6948904 RESULT

• Dreyer WP, van Heerden JD, de V Joubert JJ. The route of periodontal ligament injection of local anesthetic solution. J Endod. 1983 Nov;9(11):471-4. doi: 10.1016/S0099-2399(83)80161-7. No abstract available.

  PMID: 6586974 RESULT

• Kammerer PW, Adubae A, Buttchereit I, Thiem DGE, Daublander M, Frerich B. Prospective clinical study comparing intraligamentary anesthesia and inferior alveolar nerve block for extraction of posterior mandibular teeth. Clin Oral Investig. 2018 Apr;22(3):1469-1475. doi: 10.1007/s00784-017-2248-2. Epub 2017 Oct 15.

  PMID: 29034443 RESULT

• Meechan JG. Intraligamentary anaesthesia. J Dent. 1992 Dec;20(6):325-32. doi: 10.1016/0300-5712(92)90018-8.

  PMID: 1452871 RESULT

• Endo T, Gabka J, Taubenheim L. Intraligamentary anesthesia: benefits and limitations. Quintessence Int. 2008 Jan 1;39(1):e15-25.

  PMID: 18551207 RESULT

• Kammerer PW, Schiegnitz E, von Haussen T, Shabazfar N, Kammerer P, Willershausen B, Al-Nawas B, Daublander M. Clinical efficacy of a computerised device (STA) and a pressure syringe (VarioJect INTRA) for intraligamentary anaesthesia. Eur J Dent Educ. 2015 Feb;19(1):16-22. doi: 10.1111/eje.12096. Epub 2014 Mar 20.

  PMID: 24646115 RESULT

• Reed KL, Malamed SF, Fonner AM. Local anesthesia part 2: technical considerations. Anesth Prog. 2012 Fall;59(3):127-36; quiz 137. doi: 10.2344/0003-3006-59.3.127.

  PMID: 23050753 RESULT

• Dumbrigue HB, Lim MV, Rudman RA, Serraon A. A comparative study of anesthetic techniques for mandibular dental extraction. Am J Dent. 1997 Dec;10(6):275-8.

  PMID: 9590915 RESULT

• Prama R, Padhye L, Pawar H, Rajput N. Efficacy of Intraligamentary Injections as a Primary Anesthetic Technique for mandibular molars & a comparison with inferior alveolar nerve block. Indian Journal of Multidisciplinary Dentistry. 2013 Aug 1;3(4).

  RESULT

• Malamed SF. Handbook of local anesthesia. Elsevier Health Sciences; 2004 Jun 8.

  RESULT

• Youssef BR, Sohnel A, Welk A, Abudrya MH, Baider M, Alkilzy M, Splieth C. RCT on the effectiveness of the intraligamentary anesthesia and inferior alveolar nerve block on pain during dental treatment. Clin Oral Investig. 2021 Aug;25(8):4825-4832. doi: 10.1007/s00784-021-03787-x. Epub 2021 Feb 1.

  PMID: 33527192 DERIVED

MeSH Terms

Conditions

Dental Caries; Pain

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian splieth, PHD

  University Medicine of Greifswald

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 24, 2020
• Study Start: December 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: June 15, 2019
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)