Post Operative PainNCT05478044
Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.
A study testing Ascorbic acid and saline in people with Post Operative Pain, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ascorbic acid and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Aug 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
Kariman Amin Ismaiel, B.D.S faculty of dentistry contact
About this study
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.
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.
- Conditions
- Post Operative Pain
- Being tested
- Ascorbic acid, saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Also called Vitamin C
Ascorbic acid IV ampoules (20%).
salineOther
saline (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid | Experimental | Ascorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping. Receives: Drug: Ascorbic acid |
| Saline | Placebo comparator | A mixture of sodium chloride and water (0.9%) as a final flush irrigation 3 ml after cleaning and shaping. Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by numerical rating scale where 0= no pain, 1-3= mild pain, 4-6= moderate pain and 7-10= severe pain.
Measured: 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.
Measured: up to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kariman Mohammed Mohammed Amin Ismaiel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478044
- Sponsor's protocol ID
- ENDO 3 - 7 - 1
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05478044
- Acronym / sponsor ID
- ENDO 3 - 7 - 1
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 28 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid | Experimental | Drug: Ascorbic acidAscorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping. |
| Saline | Placebo comparator | Other: salineA mixture of sodium chloride and water (0.9%) as a final flush irrigation 3 ml after cleaning and shaping. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Ascorbic acidAlso: Vitamin CAscorbic acid IV ampoules (20%). | Drug | Ascorbic acid |
| salinesaline (0.9%) | Other | Saline |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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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.
Kariman Amin Ismaiel, B.D.S faculty of dentistry contact
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic acid and saline in people with Post Operative Pain, run by Cairo University.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kariman Amin Ismaiel, B.D.S faculty of dentistry (+20 1013665586, kariman.ameen@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2022.