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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06081335
Other study ID # 945
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2023
Est. completion date June 5, 2023

Study information

Verified date November 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 5, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Single rooted mandibular second premolar teeth with complete root formation - Pulpal diagnosis: Symptomatic irreversible pulpitis - Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area - Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization Exclusion Criteria: 1. The presence of any systemic disease or allergic reactions 2. Pregnant and lactating females 3. Patients on antibiotic or anti-inflammatory medication 4. Use of analgesics a week prior to treatment 5. A radiographically untraceable canal or an excessively curved root 6. The presence of periapical radiolucency or sinus tract. 7. Teeth with open apices 8. Severe periodontal disease (generalized or localized to the tooth in question) 9. Absence of bleeding in the pulp chamber on access cavity preparation 10. Internal or external resorption

Study Design


Intervention

Device:
EdgeEndo x7 continuous rotation files
endodontic files operating in continuous rotation
EdgeOne Fire reciprocating files
endodontic files operating in reciprocating motion

Locations

Country Name City State
Egypt Ain Shams University Cairo Select A State Or Province
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary difference in substance P levels tested by radioimmunacy (ELISA) pre-operatively and after 5 days at the beginning of the second visit
Primary post operative pain levels Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours
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