Post-operative PainNCT06206304
Relationship of Eye Colour With Anesthetic Success and Post-Operative Pain
An observational study of Post-operative Pain and Irreversible Pulpitis, run by Mustafa Kemal University at 2 sites in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Irreversible Pulpitis
- What is being tested?
- Root canal therapy
- How many people
- 110 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Jun 2023to 11 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: University endodontics clinic
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
Hatay, Antakya, 31000
Mustafa Kemal University
Hatay, Antakya, 31000
About this study
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
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.
Read the detailed 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.
- Conditions
- Post-operative Pain, Irreversible Pulpitis
- Being tested
- Root canal therapy
- Keywords
- eye color, inferior alveolar nerve block, irreversible pulpitis, phenotype, post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal therapyOther
Traditional root canal therapy was performed with rubber-dam isolation.
| Study group | Role | What they receive |
|---|---|---|
| Light-eyed females | Blue-green colors were categorized as light Receives: Other: Root canal therapy | |
| Dark-eyed females | All shades of brown were categorized as dark. Receives: Other: Root canal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start18 Jun 2023
- Primary completion4 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sari, Mustafa Kemal University
- Investigators
- Merve Sarı, DDS, Principal investigator, Mustafa Kemal UniversityKoray Yılmaz, DDS,MSc, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206304
- Sponsor's protocol ID
- 231412
- Status last verified
- May 2024
- First submitted
- 4 Jan 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23146638Liem 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.
PubMed 15731586SUTTON 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.
PubMed 13835852Hyde 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.
PubMed 29506886Mogil 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.
PubMed 12663858Liem 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.
PubMed 15277908Sari 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.
PubMed 39479199
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06206304
- Acronym / sponsor ID
- 231412
- Conditions
- Post-operative Pain, Irreversible Pulpitis
- Keywords
- eye color, inferior alveolar nerve block, irreversible pulpitis, phenotype, post-operative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 18 Jun 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light-eyed females | – | Other: Root canal therapyBlue-green colors were categorized as light |
| Dark-eyed females | – | Other: Root canal therapyAll shades of brown were categorized as dark. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University endodontics clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root canal therapyTraditional root canal therapy was performed with rubber-dam isolation. | Other | Dark-eyed females, Light-eyed females |
Primary outcome
post-operative pain
Time frame: 1 week
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 23146638Droll 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.
- Background: PubMed 15731586Liem 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.
- Background: PubMed 13835852SUTTON 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.
- Background: PubMed 29506886Hyde 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.
- Background: PubMed 12663858Mogil 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.
- Background: PubMed 15277908Liem 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.
- Derived from this study: PubMed 39479199Sari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Sarı, DDS principal investigator
Mustafa Kemal University
Koray Yılmaz, DDS,MSc study director
Cukurova University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Pain and Irreversible Pulpitis, run by Mustafa Kemal University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06206304, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.