Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206304
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-01-04
Brief Title:
Relationship of Eye Colour With Anesthetic Success and Post-Operative Pain
Sponsor:
Mustafa Kemal University
Organization:
Mustafa Kemal University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1100000 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
110 adult patients experiencing moderate or severe pain with SIP participated in this prospective study All patients received IANB of 4 articaine with 1100000 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 Patients Eye Color Categorization of the patients 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 18 mL 4 articaine with 1100000 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 05 mm shorter than the 00 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 25 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 2504 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
Categorization Of The Patients Eye Color Categorization of the patients 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 18 mL 4 articaine with 1100000 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 05 mm shorter than the 00 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 25 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 2504 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None