Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.
Effect of Ascorbic Acid as a Final Flush on Post-operative Pain After Single Visit Root Canal Treatment for Patients With Symptomatic Irreversible Pulpits Related to Mandibular Molars: Randomized Controlled Trial.
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The study is conducted to evaluate the effect of Ascorbic acid as a final flush on post operative pain after single visit root canal treatment in cases with symptomatic irreversible pulpits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedAugust 1, 2022
July 1, 2022
1 year
July 24, 2022
July 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity measured by numerical rating scale where 0= no pain, 1-3= mild pain, 4-6= moderate pain and 7-10= severe pain.
up to 48 hours after root canal treatment.
Secondary Outcomes (1)
If there are analgesics taken by the patient after root canal treatment and that will be measured by a questionnaire.
up to 48 hours.
Study Arms (2)
Ascorbic acid
EXPERIMENTALAscorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping.
Saline
PLACEBO COMPARATORA mixture of sodium chloride and water (0.9%) as a final flush irrigation 3 ml after cleaning and shaping.
Interventions
Eligibility Criteria
You may qualify if:
- Patients above 18 years old and to 60.
- Male or female.
- Patients seeking root canal treatment.
- mandibular molar teeth with symptomatic irreversible pulpits with preoperative acute or moderate pain with hot and cold stimulation with normal periapical radiographic appearance .
- healthy patient (ASA I,II).
- Patient who can understand NRS and sign informed consent.
You may not qualify if:
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- External root resorption.
- Internal root resorption.
- Vertical root fracture.
- Periapical lesion.
- Pregnancy.
- Use of ibuprofen in the last 12 hour.
- Bleeding disorder.
- Long term corticosteroid use.
- Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal therapy.
- Non-restorability.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Kariman Amin Ismaiel, B.D.S faculty of dentistry
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research assistant of endodontics
Study Record Dates
First Submitted
July 24, 2022
First Posted
July 28, 2022
Study Start
August 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
August 1, 2022
Record last verified: 2022-07