Effect of Ascorbic Acid Final Flush on Post-operative Pai... | NCT05478044

Studies
Effect of Ascorbic Acid Final Flush on Post-operative Pain in Mandibular Molars.

NCT05478044

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 1, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Post Operative Pain

Interventions

Ascorbic acid
saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2022Estimated

Primary Completion Date

Aug 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Jul 24, 2022

First Submission Date that Met QC Criteria

Jul 26, 2022

First Posted Date

Jul 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2022

Last Update Posted Date

Aug 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ascorbic acid	Drug	Ascorbic acid IV ampoules (20%).	Ascorbic acid	Vitamin C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
If there are analgesics taken by the patient after root canal treatment and that will be measured by a questionnaire.		up to 48 hours.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kariman Amin Ismaiel, B.D.S faculty of dentistry	Contact	+20 1013665586		kariman.ameen@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided