Effect of Commiphora Myrrh Solution as a Root Canal Irrig... | NCT06310044

Studies
Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth

NCT06310044

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 13, 2024Actual

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Necrotic Pulp

Interventions

Root canal irrigant Commiphora Myrrh 50%

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

Mar 2024

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

May 1, 2024Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Mar 7, 2024

First Submission Date that Met QC Criteria

Mar 7, 2024

First Posted Date

Mar 13, 2024Actual

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

Mar 7, 2024

Last Update Posted Date

Mar 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit.

Detailed Description

The patients will be randomly divided into 2 groups. Intervention group (50% Commiphora Myrrh solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant)

Post-operative pain will be measured at 6,12,24,48 hours post-operatively The pain will be recorded using numerical rating scale

Post-operative swelling will be measured at 6,12,24,48 hours post-operatively The swelling will be receded using visual swelling rating scale

Number of analgesic tablets taken by the patient post-operatively. Up to 48 hours

Amount of bacteria load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFI /ml) before and after root canal preparation.

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

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Commiphora Myrrh	Experimental	50% Commiphora Myrrh	Other: Root canal irrigant Commiphora Myrrh 50%
Sodium hypochlorite	Active Comparator	2.5% NaOCl	Other: Root canal irrigant Commiphora Myrrh 50%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Root canal irrigant Commiphora Myrrh 50%	Other	Root canal irrigant	Commiphora Myrrh Sodium hypochlorite

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative pain	Categorical None 0 Mild 1-3 Moderate 4-6 Sever 7-10	Post-operative pain measured at 6,12,24,48 hours after single visit Treatment

Secondary Outcomes

Measure	Description	Time Frame
incidence of Post-operative swelling	Categorical Of visual swelling scale of post- operative	Up to 48 hours post-

Other Outcomes

Measure	Description	Time Frame
Amount of intracanal Bacterial CFUs/ml	Intra canal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/ml) before and after root canal preparation	Pre-intervention, pre-instrumentation after access cavity. Post-instrumentation up to 10min

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Systemically healthy patient (ASA I, II).
Age between 20 and 40 years.
Male or female.
Patient who is able to sign and comprehend the pain scale (committed patient).
Mandibular single rooted premolars having the following criteria:
- With single root canal.
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pulpal pain.
- Positive pain on percussion denoting apical periodontitis.
- Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm)

Exclusion Criteria:

Medically compromised patients (ASA III or IV).
Teeth with:
Patients who could not interpret the NRS.
- Immature roots.
- Vital pulp tissues.
- Association with swelling.
- Acute peri-apical abscess or acute exacerbation of a chronic abscess.
- Mobility Grade II or III.
- Previously accessed or endodontically treated.
- Deep periodontal pockets more than 4 mm.
- Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
History of intolerance to NSAIDs.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003788	Dental Pulp Diseases
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D009336	Necrosis