NCT05478044

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 24, 2022

Last Update Submit

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

EXPERIMENTAL

Ascorbic acid IV ampoules 20% as a final flush irrigation 3ml after cleaning and shaping.

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.

Other: saline

Interventions

Ascorbic acid IV ampoules (20%).

Also known as: Vitamin C
Ascorbic acid
salineOTHER

saline (0.9%)

Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ascorbic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

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