CClinicalTrials.gg
Sign In
CompletedNCT02947763Updated Jul 12, 2019

Single Versus Multiple Visits Endodontic Treatment

A Phase 1 interventional study of mixture of metronidazole, ciprofloxacin, and minocycline in Periapical Periodontitis, sponsored by Cairo University. Completed. Open to participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by Cairo University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
16 Years to 55 Years
Sex
All
01

Study 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

Read the detailed description

Patients with necrotic teeth with apical periodontitis will be selected according to the eligibility criteria and patients are then randomized to either single visit or multiple visit using triple paste intracanal medicament. Postoperative pain will then assessed using numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing will be assessed every 3 months up to one year.

02

Conditions studied

  • Periapical Periodontitis
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 44 is close to the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult patients; age between 16-55 years old.
  2. Males or Females.

  3. 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 × 2.0 mm) related to one root in case of multi-rooted teeth.
    • Asymptomatic patients.
  4. Positive patients' acceptance for participation in the study.

Exclusion criteria

Exclusion Criteria:

  1. Primary teeth, and permanent teeth with immature apex.
  2. Teeth previously accessed or endodontically treated.
  3. Patients with diabetes and immune-compromising disease.
  4. Patients allergic to metronidazole, ciprofloxacin, or minocycline.
  5. Vital cases or necrotic without periapical lesion.
  6. Pregnant women.
  7. Teeth with unfavorable conditions for rubber-dam application.
  8. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    multiple visit

    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

  • No intervention
    single visit

    single visit root canal treatment without any intra-canal medication

Interventions

  • Drugmixture of metronidazole, ciprofloxacin, and minocycline

    placement of intracanal medication

    Also known as: no other names

06

What researchers measure

Primary outcomes

  1. postoperative pain

    using numerical rating scale from 0-10

    Time frame: 24 hours

  2. postoperative pain

    using numerical rating scale from 0-10

    Time frame: 48 hours

  3. postoperative pain

    using numerical rating scale from 0-10

    Time frame: 72 hours

  4. postoperative pain

    using numerical rating scale from 0-10

    Time frame: 7 days

Secondary outcomes

  1. Radiographic healing

    using digital radiography

    Time frame: 3 months

  2. Radiographic healing

    using digital radiography

    Time frame: 6 months

  3. Radiographic healing

    using digital radiography

    Time frame: 9 months

  4. Radiographic healing

    using digital radiography

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32047601 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02947763
Lead sponsor
Cairo University
Responsible party
Safeya AbdelRahaman Hassan (Assistant lecturer, Cairo University) — Principal investigator
First posted
Oct 28, 2016
Start date
Nov 2016
Primary completion
Jan 2018
Completion
Feb 2018
Last update
Jul 12, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontitis→

Other studies from this sponsor

Cairo University

Start the discussion