NCT06006663

Brief Summary

this study aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases.

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
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_2

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

August 17, 2023

Last Update Submit

August 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • measurment of microbial reduction as result of applying synthetic and herbaal intracanal medicaments

    sample 1 will be taken after gutta percha removal sample 2 will be taken after cleaning and shaping sample 3 will be taken after apllying the intracanal medicament for one week

    time necessary for incubation of each sample is 24 hour

Study Arms (4)

group 1

ACTIVE COMPARATOR

ibuprofen as intracanal medicament

Drug: Ibuprofen 400 mg.

group 2

ACTIVE COMPARATOR

modified triple antibiotic paste as intracanal medicament

Drug: modified triple antibiotic paste

group 3

ACTIVE COMPARATOR

curcumin as intracanal medicament

Dietary Supplement: curcumin

group 4

ACTIVE COMPARATOR

olive leaves as intracanal medicament

Dietary Supplement: olive leaves extract

Interventions

synthetic intracanal medicament

group 1

synthetic intracanal medicament

Also known as: clindamycin, ciprofloxacin and metronidazole
group 2
curcuminDIETARY_SUPPLEMENT

herbal intracanal medicament

group 3
olive leaves extractDIETARY_SUPPLEMENT

herbal intracanal medicament

group 4

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Single rooted teeth.
  • Teeth have clinical signs and symptoms of endodontic failure as sensitivity to percussion, pain, swelling or fistula.
  • Teeth with radiographic features of endodontic failure as persistent periapical lesion or widening of periodontal ligament.

You may not qualify if:

  • Teeth with fractures of the crown or root.
  • Teeth with periodontal pocket deeper than 4mm.
  • Teeth have procedural error like ledge, broken instrument, or perforation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

IbuprofenClindamycinCiprofloxacinMetronidazoleCurcumin

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydratesFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNitroimidazolesNitro CompoundsImidazolesAzolesDiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Central Study Contacts

alaa essam abo laimon, demonstrator at university

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator , Endodontic department,Faculty of dentistry,Tanta university

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

August 26, 2023

Primary Completion

October 5, 2023

Study Completion

December 10, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08