search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
RCT-SV
RCT-TVWD
RCT-TVWOD
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Teeth, Endodontically-Treated focused on measuring tooth, nonvital

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Sites / Locations

  • Moderne OdontolgiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Root canal treatment in single visit - RCT-SV

Root canal treatment in two visits with intracanal dressing - RCT-TVWD

Root canal treatment in two visits without intracanal dressing - RCT-TVWOD

Arm Description

Group 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).

Group 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).

Group 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient's postoperative pain using questionnaire
Patients will answer a questionnaire for the analysis of postoperative pain, through the analogue pain scale: (a) No pain; (b) Mild pain; (c) Moderate pain; (d) Severe pain; (e) Intense pain.
Patient's preference regarding the number of clinical visits using questionnaire
Data on the patient's preference regarding the number of clinical visits to be planned for the conduction of endodontic treatment, patients will answer their preferences according to hypothetical conditions described in a previously delivered questionnaire: (a) Single visit; (b) Multiple visits; (c) No preference.
Patient's post-treatment satisfaction using questionnaire
Post-treatment satisfaction questionnaire will be applied to patients undergoing clinical interventions in a single visit and two visits, using the following criteria: (a) Fully satisfied; (b) Satisfied; (c) Neither dissatisfied nor satisfied; (d) Dissatisfied; (e) Totally dissatisfied.

Full Information

First Posted
December 4, 2021
Last Updated
October 31, 2022
Sponsor
New York University
search

1. Study Identification

Unique Protocol Identification Number
NCT05256667
Brief Title
Comparison Between RCT in Single and Two Visits, With and Without Intracanal Dressing, in Apical Repair
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2021 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
May 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
All patients will voluntarily seek endodontic treatment in the Brazilian Unified Health System in the cities of Itabuna, in the State of Bahia, in Goiânia, in the State of Goiás, Brazil. After an assessment of eligibility and informed consent, patients will be randomly assigned to one of 3 clinical study groups. Patients who agree to participate in this study will sign an informed consent form. Sample Size: The determination of the sample size will be performed sequentially, with a minimum of 210 statistical units (teeth) to be recruited in the first stage, and the second stage of recruitment will be performed if the selection is insufficient to clinically and radiographically identify valid cases. This sampling will also allow the adjustment of the sample size for the intra-subject correlation of statistical units (teeth). In the first stage, 150 adults aged 18 to 60 years, with at least one tooth diagnosed with asymptomatic apical periodontitis and periradicular lesion with a diameter between 1 and 5 mm, will be recruited. Allocation and blinding: Only examiners can open the envelope to check the group allocation and perform the interventions according to the instructions of this study. As a double-blinded trial, the patients and outcome evaluators will be blinded to the group assignment until the completion of the study. Interventions: In order to treat apical periodontitis, in the first visit, the same endodontic instrumentation protocol will be performed for all teeth randomly divided into the 3 study groups. What will vary will be complementary and additional maneuvers such as the use of ultrasonic activation and intracanal medication between visits of endodontic instrumentation. All endodontic therapy procedures will be performed under a dental microscope, except for anesthesia and rubber dam placement steps. The study will be conducted in the private offices of two of the co-investigators involved in the study (GMA and VHMC), located in the cities of Itabuna (Bahia) and Goiânia (Goiás), Brazil, respectively. All investigators and examiners are specialists in Endodontics with more than 10 years of clinical experience. They will participate in this randomized clinical trial after receiving adequate training to obtain a comprehensive view of the principles and strategy of the 3 clinical approaches that will be used. Description: First clinical appointment: The first visit will include the following clinical protocol depending on the study group. For the 3 groups (Group 1, Group 2 and Group 3): (1) Anesthesia and caries removal: After local anesthesia with articaine hydrochloride and epinephrine injection (with 1:200,000 adrenaline), all decayed tissue from the tooth is removed; (2) Isolation and access preparation. The tooth is isolated with a rubber dam, disinfected and the pulp chamber will be completely unroofed; (3) Initial irrigation with 5 ml of 5.25% NaOCl; (4) Root canal preparation: The #10 C-Pilot file will be used to perform the glide path along the length of the tooth on the radiograph, irrigated with 2 ml of 5.25% NaOCl, followed by rotary instrumentation with #15/.03, #25/.04 and #30/.05 NiTi files, initially in the cervical and middle thirds, after which the working length with foraminal locator will be performed. Finally, the instrumentation of the apical third will be performed with the same sequence of NiTi rotary files used previously; (5) The canal will be copiously irrigated in three stages using 10ml of 5.25% NaOCl for each of thirds: cervical, middle and apical, totaling 30ml, followed by a final rinse with 10ml of 5.25% NaOCl stirred with the ultrasonic inserts and 10 ml of 17% EDTA stirred also with ultrasonic inserts. The final rinse will be carried out with 10ml of saline solution. Intracanal dressing: Group 1 will not receive intracanal dressing because it will be concluded in single visit. Group 2 will receive intracanal dressing with Ca(OH)2/CPMC/glycerin paste for a period of 7 days. To restrict bacterial regrowth and supply continued disinfection, the root canal will be filled homogeneously to the working length with Ca(OH)2/CPMC/glycerin paste. The tooth will be shielded with glass ionomer cement (GIC) as a temporary restoration. Group 3 will be without intracanal dressing for a period of 2 days, taking into account that the tooth will be shielded with GIC as a temporary restoration. Obturation: Only for Group 1, the root canals will be filled in the first visit. In this group, a #30/.05 gutta-percha cone and epoxy resin-based sealer with the continuous heat wave technique and a final restoration with composite resin will be used. Second clinical appointment: The second visit will include the following clinical protocol depending on the study group. For the 2 remaining groups (Group 2 and Group 3): (1) Anesthesia and restorative material removal. After local anesthesia with articaine hydrochloride and epinephrine injection (with 1:200,000 adrenaline, all temporary restorative material from the tooth is removed. (2) Isolation and Access. The tooth is isolated with a rubber dam and the root canal will be accessed one more time. Group 2: (1) After 7 days, the intracanal dressing will be removed and the root canal will receive a new chemo-mechanical preparation, identical to the one performed in the first visit, and then it will be filled and permanently restored similarly to Group 1. Group 3: (1) After 2 days, the root canal will receive a new chemo-mechanical preparation, identical to the one performed in the first visit, and then it will be filled and permanently restored similarly to Group 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth, Endodontically-Treated, Tooth, Nonvital, Periapical Periodontitis, Chronic Nonsuppurative, Periapical Granuloma
Keywords
tooth, nonvital

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Root canal treatment in single visit - RCT-SV
Arm Type
Other
Arm Description
Group 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).
Arm Title
Root canal treatment in two visits with intracanal dressing - RCT-TVWD
Arm Type
Other
Arm Description
Group 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).
Arm Title
Root canal treatment in two visits without intracanal dressing - RCT-TVWOD
Arm Type
Other
Arm Description
Group 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).
Intervention Type
Combination Product
Intervention Name(s)
RCT-SV
Intervention Description
Group 1- Endodontic treatment in a single visit using chemomechanical preparation and passive ultrasonic irrigation, followed by obturation and final restoration.
Intervention Type
Other
Intervention Name(s)
RCT-TVWD
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
RCT-TVWOD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing of periradicular lesions by radiographic findings according to periapical Index (PAI)
Description
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.
Time Frame
Long-term follow-up evaluation in 24 months.
Secondary Outcome Measure Information:
Title
Patient's postoperative pain using questionnaire
Description
Patients will answer a questionnaire for the analysis of postoperative pain, through the analogue pain scale: (a) No pain; (b) Mild pain; (c) Moderate pain; (d) Severe pain; (e) Intense pain.
Time Frame
Evaluation of postoperative pain after endodontic treatment completion, an average of 7 days.
Title
Patient's preference regarding the number of clinical visits using questionnaire
Description
Data on the patient's preference regarding the number of clinical visits to be planned for the conduction of endodontic treatment, patients will answer their preferences according to hypothetical conditions described in a previously delivered questionnaire: (a) Single visit; (b) Multiple visits; (c) No preference.
Time Frame
Immediately before starting endodontic treatment.
Title
Patient's post-treatment satisfaction using questionnaire
Description
Post-treatment satisfaction questionnaire will be applied to patients undergoing clinical interventions in a single visit and two visits, using the following criteria: (a) Fully satisfied; (b) Satisfied; (c) Neither dissatisfied nor satisfied; (d) Dissatisfied; (e) Totally dissatisfied.
Time Frame
Immediately after endodontic treatment completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Queiroz, DDS, MS
Phone
646-269-2447
Email
esq200@nyu.edu
Facility Information:
Facility Name
Moderne Odontolgia
City
Itabuna
State/Province
Bahia
ZIP/Postal Code
45605
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Almeida, DDS, MS
Phone
+55 73 3613-3017
Email
drgustavoalmeida01@gmail.com
First Name & Middle Initial & Last Name & Degree
Gustavo Almeida, DDS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will share, protocol, methods, results
IPD Sharing Time Frame
after publication - for 6 months
IPD Sharing Access Criteria
Free
IPD Sharing URL
http://scholar.google.com

Learn more about this trial

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

We'll reach out to this number within 24 hrs