Comparison Between RCT in Single and Two Visits, With and Without Intracanal Dressing, in Apical Repair
Comparison Between Root Canal Treatment in Single and Two Visits, With and Without the Use of Intracanal Dressing, in Periradicular Repair in Teeth With Apical Periodontitis: Double-blinded, Controlled Randomized Trial
1 other identifier
interventional
210
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2021
CompletedFirst Submitted
Initial submission to the registry
December 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2024
CompletedNovember 3, 2022
February 1, 2022
2.5 years
December 4, 2021
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Healing of periradicular lesions by radiographic findings according to periapical Index (PAI)
The periapical index (PAI) is a structured scoring system for categorization of radiographic features of apical periodontitis. It is based on a visual scale of periapical periodontitis severity and was built upon a classical study of histological-radiological correlations. It is a five-point ordinal scale as listed below: 1. Normal periapical structures; 2. Small changes in bone structure with no demineralization; 3. Changes in bone structure with some diffuse demineralization; 4. Apical periodontitis with well-defined radiolucent area; 5. Severe apical periodontitis, with exacerbating features.
Long-term follow-up evaluation in 24 months.
Secondary Outcomes (3)
Patient's postoperative pain using questionnaire
Evaluation of postoperative pain after endodontic treatment completion, an average of 7 days.
Patient's preference regarding the number of clinical visits using questionnaire
Immediately before starting endodontic treatment.
Patient's post-treatment satisfaction using questionnaire
Immediately after endodontic treatment completion.
Study Arms (3)
Root canal treatment in single visit - RCT-SV
OTHERGroup 1- RCT-SV: Endodontic treatment in a single visit using chemomechanical preparation (rotary NiTi instruments, 5.25% NaOCl, 17% EDTA) and passive ultrasonic irrigation (PUI), followed by obturation (gutta-percha and epoxy resin-based sealer) and final restoration (composite resin).
Root canal treatment in two visits with intracanal dressing - RCT-TVWD
OTHERGroup 2- RCT-TVWD: Endodontic treatment in two visits using chemomechanical preparation (rotary NiTi instruments, 5.25% NaOCl, 17% EDTA) and passive ultrasonic irrigation (PUI), followed by intracanal dressing (calcium hydroxide powder, CPMC, glycerine) and temporary restoration (glass ionomer cement) for 7 days. After 7 days, an identical chemomechanical preparation on visit 2 will be performed, followed by obturation (gutta-percha and epoxy resin-based sealer) and final restoration (composite resin).
Root canal treatment in two visits without intracanal dressing - RCT-TVWOD
OTHERGroup 3- RCT-TVWOD: Endodontic treatment in two visits using chemomechanical preparation (rotary NiTi instruments, 5.25% NaOCl, 17% EDTA) and passive ultrasonic irrigation (PUI), followed by temporary restoration (glass ionomer cement) for 2 days, without intracanal dressing. After 2 days, an identical chemomechanical preparation on visit 2 will be performed performed, followed by obturation (gutta-percha and epoxy resin-based sealer) and final restoration (composite resin).
Interventions
Group 1- Endodontic treatment in a single visit using chemomechanical preparation and passive ultrasonic irrigation, followed by obturation and final restoration.
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.
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.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with apical periodontitis in lower molar teeth (first or second molars), the periradicular lesion with a diameter between 1 and 5mm analyzed through the real 1:1 tomographic scale
- Asymptomatic patients
- Patients who spontaneously agree and sign the informed consent form
- Patients in good health
- Patients who are not taking antibiotics and anti-inflammatory drugs
You may not qualify if:
- Patients with systemic diseases (diabetes, transplants, heart disease, liver failure and kidney failure)
- Immunodepressed patients
- Teeth with extensive coronary destruction that makes direct restoration with composite resin unfeasible
- Calcified teeth
- Teeth with incomplete root formation
- Teeth with persistent exudation
- Teeth with anatomical complexities that prevent endodontic treatment in a single visit
- Teeth recommended for endodontic retreatment
- Teeth with advanced periodontal pocket
- Teeth in which foraminal patency is not obtained
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moderne Odontolgia
Itabuna, Estado de Bahia, 45605, Brazil
Related Publications (1)
Almeida GM, Carvalho VHM, Silva EBP, Cancado MAF, Barroso LS, Queiroz EL, An TL, Ribeiro APD, Carvalho-Junior JR, Leite AF. Periradicular repair after single- and two-visit root canal treatments using ultrasonic irrigant activation and calcium hydroxide dressing of teeth with apical periodontitis: study protocol for randomized controlled trials. Trials. 2023 Jan 12;24(1):23. doi: 10.1186/s13063-022-07030-0.
PMID: 36635764DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2021
First Posted
February 25, 2022
Study Start
October 2, 2021
Primary Completion
March 28, 2024
Study Completion
May 28, 2024
Last Updated
November 3, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- after publication - for 6 months
- Access Criteria
- Free
The investigators will share, protocol, methods, results