Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2024
Source Mustafa Kemal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Female patients with no systemic diseases (ASA 1-2); aged between 18-45 years; eye colors with brown, hazel, green, or blue; mandibular molar teeth diagnosed SIP were included in this study. Categorization Of The Patient's Eye Color Categorization of the patient's eye color was made by an independent researcher. Patients were also asked to indicate their own eye color. If a consensus could not be reached between the researcher and the patient regarding eye color, the patient was excluded from the study. Blue-green colors were categorized as light; all shades of brown were categorized as dark. Root Canal Treatment Procedures All dental procedures, including anesthesia injection, were performed by a single endodontist. 119 patients received IANB injections of 1.8 mL 4% articaine with 1:100,000 epinephrine (Ultracain D-S; Sanofi, Paris, France) using Halstead method. 27-gauge needle (Beybi Medical Co., Istanbul, Turkey) were used for all injections. Anesthetic solution was slowly deposited to the target area for 60 seconds. 10 minutes after IANB anesthesia, patients were asked whether their lip were numb. Patients who reported no profound lip numbness were excluded from the study. An access cavity was prepared using a high speed steril diamond bur #801G (Meisinger) under abundant water coolant after isolation with a rubber dam. Patients were instructed to inform the operator if they felt pain during acces cavity preparation. Pain intensity was rated into 4 categories using the HP VAS. Level 1: No pain (0) Level 2: Mild pain (1-3 mm) Level 3: Moderate pain (4-6mm) Level 4: Severe pain (7-10 mm). The IANB anesthesia was defined as successful when the patient reported no pain or mild pain during cavity preparation. The IANB anesthesia was considered unsuccessful in patients with moderate or severe pain; in these cases, an intrapulpal anesthesia was performed. After localizing the canal orifices, the working length (WL) was determined using a 10 K file (VDW, Munich, Germany), to be 0.5 mm shorter than the "0.0" reading on the apex locator (Morita Root ZX, Japan), and confirmed by radiographs. Root canal were prepared using the R25 (Reciproc, VDW) file in the mesial root canals and the R25, R40, and R50 files in the distal root canals, respectively, with crown-down technique. After 3 pecking motions the file was removed from the root canal and debris on the file surface was cleaned. The pecking depth for the pecking motions were 3-4 mm. Each root canals was irrigated a total of 20 ml of 2,5% sodium hypochlorite (NaOCl; Wizard, RehberKimya, Istanbul, Turkey) solution using 30 G irrigation needle (Medic; Shangai Carelife, China). After NaOCl. 5 ml of distilled water used to neutralize the effect of NaOCl. The final irrigation was performed with 3 mL 17% ethylenediaminetetraacetic acid (EDTA; Coltene, Altstatten, Switzerland) solution. The Endoactivator (EA; Dentsply Tulsa Dental Specialties, Tulsa, OK) 25/04 tip placed 2 mm behind the WL was used in 3 cycles of 20 s each. EDTA was activated with 2-4 mm vertical movements for 1 min using the EA. 5 ml of distilled water used to neutralize the effect of EDTA followed by the root canals were dried with paper points (VDW). The root canals were filled with the lateral condensation using gutta-percha cones (VDW) and epoxy-resin-based sealer (AH Plus; Dentsply DeTrey GmbH, Konstanz, Germany) in a single visit. All teeth were restored with resin composite (Estelıte Sıgma Quıck; Tokuyama, Tokyo, Japan). The root canal filling was checked by radiographs. If any complications such as broken file, ledging, could not be reached to the WL; overfilling (filling beyond the radiographic apex) or short filling (>2 mm from the radiographic apex) the patient was excluded from the study. The patients were prescribed 400 mg of ibuprofen, and instructed to take it only in the presence of pain. Patients were asked to rate their post-op pain on the HP VAS scale at hours 24h, 48 h, 72h and on day 7 after the treatment and to record analgesic drugs they used.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
Turkey Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University Hatay Antakya
Turkey Mustafa Kemal University Hatay Antakya

Sponsors (1)

Lead Sponsor Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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

Outcome

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).
1 week
See also
  Status Clinical Trial Phase
Completed NCT02489526 - Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery Phase 2
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Terminated NCT05146453 - Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology Phase 4
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Not yet recruiting NCT03591172 - Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization N/A
Completed NCT01667445 - Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty Phase 4
Completed NCT01686802 - Post-operative Oral Morphine Versus Ibuprofen Phase 2
Completed NCT01444924 - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery Phase 2
Completed NCT00968955 - Effect of Local Infiltration Analgesia in Total Hip Arthroplasty Phase 4
Completed NCT00830089 - Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery N/A
Completed NCT00847093 - LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery Phase 4
Terminated NCT00875862 - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks Phase 4
Completed NCT00390312 - Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction Phase 2
Recruiting NCT05278494 - Dextromethorphan for Treatment of Postoperative Pain N/A
Recruiting NCT05973045 - Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy N/A
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A
Enrolling by invitation NCT04346407 - Dronabinol for Post-operative Pain After Lumbar Fusion Phase 4
Completed NCT03635515 - Occurrence of Post-op Pain Following Gentlewave N/A
Terminated NCT03201809 - Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial N/A
Completed NCT03254056 - Fascial Closure Techniques Post-Operative Pain Laparoscopy N/A