Relationship of Eye Colour With Anesthetic Success and Post-Operative Pain

NCT06206304 | Completed

• 1 other identifier: 231412
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

Current evidence indicates that some phenotypic characteristics, such as eye or hair color, might be associated with the experience of pain. We therefore compared the anaesthetic success rate of inferior alveolar nerve block (IANB), and post-operative pain scores between light and dark eyed in female patients experiencing symptomatic irreversible pulpitis (SIP) in a mandibular molar. 110 adult patients, experiencing moderate or severe pain with SIP, participated in this prospective study. All patients received IANB of 4% articaine with 1:100.000 epinephrine. Endodontic access cavity preparation was initiated after confirmed of IANB with numbness of the lower lip. Pain during treatment was recorded by using a Heft Parker Visual Analog Scale. Anaesthetic success was recorded as ''none'' or ''mild'' pain. Root canal treatment was performed, with standardized protocols. Post-operative pain scores were also recorded 24, 48, 72 hours and 7 days after treatment.

Conditions

Post-operative Pain; Irreversible Pulpitis

Keywords

eye color; inferior alveolar nerve block; irreversible pulpitis; phenotype; post-operative pain

Outcome Measures

Primary Outcomes (1)

• post-operative pain

  Pre-operative and post-operative pain scores were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories: No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm).

  1 week

Study Arms (2)

Light-eyed females

Blue-green colors were categorized as light

Other: Root canal therapy

Dark-eyed females

All shades of brown were categorized as dark.

Other: Root canal therapy

Interventions

Root canal therapy OTHER

Traditional root canal therapy was performed with rubber-dam isolation.

Dark-eyed females; Light-eyed females

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participant eligibility was based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

University endodontics clinic

You may qualify if:

• Patients with no systemic diseases
• Eye colors with brown, hazel, green, or blue; mandibular molar teeth diagnosed with SIP The diagnosis of SIP was confirmed by a a prolonged response to cold test (Endo Ice; Coltene, Altstatten, Switzerland) and positive response to electric pulp testing. Only patients with moderate (4-6 mm) or severe pain (7-10 mm) according to HP VAS were included.
• Teeth with no periodontal problem (probing pocket depth ≤3 mm and mobility within normal limit) and without periapical radiolucency (except for a widened periodontal ligament with an intact lamina dura) were included.

You may not qualify if:

• \- Patients using colored contact lenses; any surgical operation to change iris color; neurophysiological disease; taking any medications that may affect pain or anxiety assessment (nonsteroidal anti-inflammatory drugs, opioids, antidepressants, and alcohol), pregnancy

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (2)

Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University

Hatay, Antakya, 31000, Turkey (Türkiye)

Location

Mustafa Kemal University

Hatay, Antakya, 31000, Turkey (Türkiye)

Location

Related Publications (7)

• Droll B, Drum M, Nusstein J, Reader A, Beck M. Anesthetic efficacy of the inferior alveolar nerve block in red-haired women. J Endod. 2012 Dec;38(12):1564-9. doi: 10.1016/j.joen.2012.08.014. Epub 2012 Oct 3.

  PMID: 23146638 BACKGROUND

• Liem EB, Joiner TV, Tsueda K, Sessler DI. Increased sensitivity to thermal pain and reduced subcutaneous lidocaine efficacy in redheads. Anesthesiology. 2005 Mar;102(3):509-14. doi: 10.1097/00000542-200503000-00006.

  PMID: 15731586 BACKGROUND

• SUTTON PR. Association between colour of the iris of the eye and reaction to dental pain. Nature. 1959 Jul 11;184:122. doi: 10.1038/184122a0. No abstract available.

  PMID: 13835852 BACKGROUND

• Hyde J, Fowler S, Drum M, Reader A, Nusstein J, Beck M. Is Eye Color Related to Dental Injection Pain? A Prospective, Randomized, Single-blind Study. J Endod. 2018 May;44(5):734-737. doi: 10.1016/j.joen.2018.01.009. Epub 2018 Mar 2.

  PMID: 29506886 BACKGROUND

• Mogil JS, Wilson SG, Chesler EJ, Rankin AL, Nemmani KV, Lariviere WR, Groce MK, Wallace MR, Kaplan L, Staud R, Ness TJ, Glover TL, Stankova M, Mayorov A, Hruby VJ, Grisel JE, Fillingim RB. The melanocortin-1 receptor gene mediates female-specific mechanisms of analgesia in mice and humans. Proc Natl Acad Sci U S A. 2003 Apr 15;100(8):4867-72. doi: 10.1073/pnas.0730053100. Epub 2003 Mar 27.

  PMID: 12663858 BACKGROUND

• Liem EB, Lin CM, Suleman MI, Doufas AG, Gregg RG, Veauthier JM, Loyd G, Sessler DI. Anesthetic requirement is increased in redheads. Anesthesiology. 2004 Aug;101(2):279-83. doi: 10.1097/00000542-200408000-00006.

  PMID: 15277908 BACKGROUND

• Sari M, Yilmaz K. Association Between Eye Color and Postoperative Pain in Female Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Prospective, Parallel-Group, Observational Study. Pain Res Manag. 2024 Oct 23;2024:8824366. doi: 10.1155/2024/8824366. eCollection 2024.

  PMID: 39479199 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Root Canal Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Merve Sarı, DDS

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

• Koray Yılmaz, DDS,MSc

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: June 18, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 11, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)