Back to resultsEffect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.
Primary Purpose
Post Operative Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ascorbic acid
saline
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Inability to perceive the given instructions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ascorbic acid
Saline
Arm Description
Ascorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping.
A mixture of sodium chloride and water (0.9%) as a final flush irrigation 3 ml after cleaning and shaping.
Outcomes
Primary Outcome Measures
Pain intensity measured by numerical rating scale where 0= no pain, 1-3= mild pain, 4-6= moderate pain and 7-10= severe pain.
Secondary Outcome Measures
If there are analgesics taken by the patient after root canal treatment and that will be measured by a questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05478044
Brief Title
Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ascorbic acid
Arm Type
Experimental
Arm Description
Ascorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
A mixture of sodium chloride and water (0.9%) as a final flush irrigation 3 ml after cleaning and shaping.
Intervention Type
Drug
Intervention Name(s)
Ascorbic acid
Other Intervention Name(s)
Vitamin C
Intervention Description
Ascorbic acid IV ampoules (20%).
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
saline (0.9%)
Primary Outcome Measure Information:
Title
Pain intensity measured by numerical rating scale where 0= no pain, 1-3= mild pain, 4-6= moderate pain and 7-10= severe pain.
Time Frame
up to 48 hours after root canal treatment.
Secondary Outcome Measure Information:
Title
If there are analgesics taken by the patient after root canal treatment and that will be measured by a questionnaire.
Time Frame
up to 48 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Inability to perceive the given instructions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kariman Amin Ismaiel, B.D.S faculty of dentistry
Phone
+20 1013665586
Email
kariman.ameen@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.
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