NCT02947763

Brief Summary

Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2016

Status
completed

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

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

October 26, 2016

Last Update Submit

July 10, 2019

Conditions

Periapical Periodontitis

Outcome Measures

Primary Outcomes (4)

  • postoperative pain

    using numerical rating scale from 0-10

    24 hours

  • postoperative pain

    using numerical rating scale from 0-10

    48 hours

  • postoperative pain

    using numerical rating scale from 0-10

    72 hours

  • postoperative pain

    using numerical rating scale from 0-10

    7 days

Secondary Outcomes (4)

  • Radiographic healing

    3 months

  • Radiographic healing

    6 months

  • Radiographic healing

    9 months

  • Radiographic healing

    12 months

Study Arms (2)

multiple visit

ACTIVE COMPARATOR

multiple visit root canal treatment with triple antibiotic paste intracanal medication (a mixture of metronidazole, ciprofloxacin, and minocycline)

Drug: mixture of metronidazole, ciprofloxacin, and minocycline

single visit

NO INTERVENTION

single visit root canal treatment without any intra-canal medication

Interventions

mixture of metronidazole, ciprofloxacin, and minocyclineDRUG

placement of intracanal medication

Also known as: no other names
multiple visit

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adult patients; age between 16-55 years old.
  • Males or Females.
  • Maxillary or mandibular single-root tooth or a multi-rooted tooth with:
  • Non-vital response of pulp tissue.
  • Radiographic evidence of periapical lesions (minimum size 2.0 mm Ă— 2.0 mm) related to one root in case of multi-rooted teeth.
  • Asymptomatic patients.
  • Positive patients' acceptance for participation in the study.

You may not qualify if:

  • Primary teeth, and permanent teeth with immature apex.
  • Teeth previously accessed or endodontically treated.
  • Patients with diabetes and immune-compromising disease.
  • Patients allergic to metronidazole, ciprofloxacin, or minocycline.
  • Vital cases or necrotic without periapical lesion.
  • Pregnant women.
  • Teeth with unfavorable conditions for rubber-dam application.
  • Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • AbdurRahman S, Abdel Aziz SM, Gawdat SI, AbdalSamad AM. Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial. F1000Res. 2019 Jul 26;8:1203. doi: 10.12688/f1000research.19936.1. eCollection 2019.

    PMID: 32047601DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

CiprofloxacinMinocycline

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share