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Comparison Between RCT in Single and Two Visits, With and Without Intracanal Dressing, in Apical Repair

NCT05256667 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-11-03

No results posted yet for this study

Summary

This is a randomized, prospective, double-blind, controlled clinical trial designed to evaluate 3 distinct clinical approaches used during endodontic therapy: Group 1- Root canal treatment in single visit (RCT-SV); Group 2- Root canal treatment in two visits with intracanal dressing (RCT-TVWD); Group 3- Root canal treatment in two visits without intracanal dressing (RCT-TVWOD). A total of 210 adult patients ages 18 to 60 years, with at least one tooth diagnosed with asymptomatic apical periodontitis and periradicular lesion will be randomized and will undergo one of the types of clinical approaches during endodontic therapy. Patients' postoperative pain levels will also be recorded in periods of 24, 48, 72 hours and 7 days. Subsequently, clinical findings and long-term follow-up evaluations, with periradicular repair will be performed by periapical radiograph and computed tomography (cone-beam) at 6th, 12th and 24th months.

Conditions

  • Teeth, Endodontically-Treated
  • Tooth, Nonvital
  • Periapical Periodontitis, Chronic Nonsuppurative
  • Periapical Granuloma

Interventions

COMBINATION_PRODUCT

RCT-SV

Group 1- Endodontic treatment in a single visit using chemomechanical preparation and passive ultrasonic irrigation, followed by obturation and final restoration.

OTHER

RCT-TVWD

Group 2- Endodontic treatment in two visits using chemomechanical preparation and passive ultrasonic irrigation, followed by intracanal dressing and temporary restoration for 7 days. After 7 days, an identical chemomechanical preparation on visit 2 will be performed, followed by obturation and final restoration.

OTHER

RCT-TVWOD

Group 3- Endodontic treatment in two visits using chemomechanical preparation and passive ultrasonic irrigation, followed by temporary restoration for 2 days, without intracanal dressing. After 2 days, an identical chemomechanical preparation on visit 2 will be performed, followed by obturation and final restoration.

Sponsors & Collaborators

  • New York University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-02
Primary Completion
2024-03-28
Completion
2024-05-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256667 on ClinicalTrials.gov