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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02947763
Other study ID # CEBD-CU-2016-10-231
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2016
Est. completion date February 2018

Study information

Verified date July 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date February 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 55 Years
Eligibility 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:

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
mixture of metronidazole, ciprofloxacin, and minocycline
placement of intracanal medication

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative pain using numerical rating scale from 0-10 24 hours
Primary postoperative pain using numerical rating scale from 0-10 48 hours
Primary postoperative pain using numerical rating scale from 0-10 72 hours
Primary postoperative pain using numerical rating scale from 0-10 7 days
Secondary Radiographic healing using digital radiography 3 months
Secondary Radiographic healing using digital radiography 6 months
Secondary Radiographic healing using digital radiography 9 months
Secondary Radiographic healing using digital radiography 12 months
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