Single Versus Multiple Visits Endodontic Treatment

NCT ID: NCT02947763

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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multiple visit

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

Group Type ACTIVE_COMPARATOR

mixture of metronidazole, ciprofloxacin, and minocycline

Intervention Type DRUG

placement of intracanal medication

single visit

single visit root canal treatment without any intra-canal medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mixture of metronidazole, ciprofloxacin, and minocycline

placement of intracanal medication

Intervention Type DRUG

Other Intervention Names

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no other names

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Safeya AbdelRahaman Hassan

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 32047601 (View on PubMed)

Other Identifiers

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CEBD-CU-2016-10-231

Identifier Type: -

Identifier Source: org_study_id

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