Post-operative Pain Clinical Trial
Official title:
Evaluation of the Relationship Between Eye Color and Post-Operative Pain in Female Patients Experiencing Symptomatic Irreversible Pulpitis in A Mandibular Molar: A Prospective, Parallel-Group, Observational Clinical Study
NCT number | NCT06206304 |
Other study ID # | 231412 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 18, 2023 |
Est. completion date | December 11, 2023 |
Verified date | May 2024 |
Source | Mustafa Kemal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 11, 2023 |
Est. primary completion date | December 4, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University | Hatay | Antakya |
Turkey | Mustafa Kemal University | Hatay | Antakya |
Lead Sponsor | Collaborator |
---|---|
Mustafa Kemal University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
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