Apical PeriodontitisNCT03243357
In Vivo Assessment of Endodontics Procedures
A study testing TF Adaptive (First Apical Binding File) in people with Apical Periodontitis, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would be that the choose of this system based on the anatomical characteristics of the canal and the biological precepts. In teeth with lesions, contaminated dentin should be removed. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- TF Adaptive (First Apical Binding File)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Nov 2017to 3 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants who have in their mandibular or maxillary molar teeth apical periodontitis symptomatic or asymptomatic with apical radiolucence.
Who cannot join
- Patients with medical history compromises outcomes
- Atresic and root canals
- Root canals with curvature greater than 30 degrees
- Previously performed endodontics treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Uberlandia
Uberlândia, Minas Gerais, 38405-900
Camilla C Gomes Moura, PhD, +55 34 99924 9586, camillahistologia@yahoo.com.br
Thaís C Cunha, Ms, +55 34 99172 1990, christina.thais@gmail.com
About this study
In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would be that the choose of this system based on the anatomical characteristics of the canal and the biological precepts. In teeth with lesions, contaminated dentin should be removed. However, in many systems, the manufacturer's approach disregards the fact that in wider root canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch the walls at the final apical. Therefore, the establishment of the initial apical file (LAI), the first instrument that measures the resistance of the walls in working length, could be a criterion in the choice of which system to use, and how many files work within the root canals after LAI determination. However, there is a lack of studies that demonstrate that LAI determination affects the degree of cleaning achieved, as well as the impact that LAI-based instrumentation may have on microcracks formation, canal transportation, postoperative pain and quality of obturation.In this way, the investigators propose a study in vivo performed, in patients from 8 to 18 years of age, therefore in large root canals. The protocol recommended by the manufacturer will be compared by means of a prospective randomized clinical trial, with the addition of the XP Endo finisher and with the protocol based on the initial apical file evaluating postoperative pain, exacerbation between the sessions, the quality of the obturation and periapical radiolucency repair. Considering that currently performing endodontic treatments using mechanized instruments is taught in undergraduate courses throughout the country, studies of this nature help the execution of a endodontics more critical and effective.
Read the detailed description
Infected root canal treatments will be performed in two sessions with a TF Adaptive system (Protocol recommended by manufacturer (Group Control) vs. Protocol based on the initial apical file). The root canals will be completed after 14 days. Patients will record postoperative pain during the follow-up period (7 days) using a Visual analogue scale (VAS) and the change in periapical radiolucency will be assessed by periapical index (PAI) scores.
- Conditions
- Apical Periodontitis
- Being tested
- TF Adaptive (First Apical Binding File), TF Adaptive (Control)
- Keywords
- Endodontics, molars, instrumentation, obturation, anatomy
- Medical subject headings
- Periapical Periodontitis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF Adaptive (First Apical Binding File)Procedure or surgery
Procedure: TF Adaptive System NiTi (Nickel titanium) Endo File System (SybronEndo) The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).
Procedure: Instrumentation based on protocol of First Apical Binding File The enlargement of the root canal will be performed with three files larger than the diameter of the previously established initial apical file.
TF Adaptive (Control)Procedure or surgery
Also called TF Adaptive (Manufacturer's protocol)
Procedure: TF Adaptive System NiTi (Nickel titanium)Endo File System The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).
Procedure: Instrumentation based on manufacturer's protocol The enlargement of the root canal will be performed according to the manufacturer's directions.
| Study group | Role | What they receive |
|---|---|---|
| TF Adaptive (First Apical Binding File) | Experimental | Endodontic treatment(teeth with periapical periodontitis\&radiolucence).Local anesthesia (4%Articaine with1:100,000 epinephrine),isolation with rubber dam\&standard access cavity preparation.Using 2.5 %sodium hypochlorite,canal negotiation,glide path,coronal flaring with Sx(ProTaper),determining working length\&first apical binding file.Intervention: Root canal instrumentation:TF Adaptive system with enlargement of the root canal performed with up to 3 files larger than the diameter of the initial apical file. Irrigation2.5%NaOCl\&EDTA (Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, obturation: gutta-percha\&epoxy resin sealer. Receives: Procedure: TF Adaptive (First Apical Binding File) |
| TF Adaptive (Control) | Other | In the control group,endodontic treatment (teeth with periapical periodontitis\&radiolucence). Local anesthesia(4% Articaine with 1:100,000 epinephrine), isolation with rubber dam\&standard access cavity preparation. Using 2.5 % sodium hypochlorite, canal negotiation, determining working length\&glide path. Root canal instrumentation:TF Adaptive system according to the protocol recommended by the manufacturer.Irrigation 2.5% NaOCl \& EDTA(Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, the canals will be obturated with gutta-percha and epoxy resin sealer. Receives: Procedure: TF Adaptive (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
A Visual Analogue Scale VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.
Measured: 7 days
Secondary outcomes (1)
Periapical radiolucence Repair
The change will be observed in periapical radiolucence in X-ray at the 6 and 12-month follow-up visit to assess the treatment outcome The outcome measure will be the change in periapical radiolucency as assessed by periapical index (PAI) scores.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start22 Nov 2017
- Primary completion7 Mar 2020 (estimated)
- Study completion3 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Christian Gomes Moura, Federal University of Uberlandia
- Investigators
- Camilla C Gomes Moura, PhD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243357
- Sponsor's protocol ID
- 68089517.2.0000.5152
- Status last verified
- May 2019
- First submitted
- 26 Jul 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Assessment of Endodontics Procedures
- ClinicalTrials.gov ID
- NCT03243357
- Acronym / sponsor ID
- 68089517.2.0000.5152
- Conditions
- Apical Periodontitis
- Keywords
- Endodontics, molars, instrumentation, obturation, anatomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 7 Mar 2020 (estimated)
- Study completion
- 3 Nov 2020 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would be that the choose of this system based on the anatomical characteristics of the canal and the biological precepts. In teeth with lesions, contaminated dentin should be removed. However, in many systems, the manufacturer's approach disregards the fact that in wider root canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch the walls at the final apical. Therefore, the establishment of the initial apical file (LAI), the first instrument that measures the resistance of the walls in working length, could be a criterion in the choice of which system to use, and how many files work within the root canals after LAI determination. However, there is a lack of studies that demonstrate that LAI determination affects the degree of cleaning achieved, as well as the impact that LAI-based instrumentation may have on microcracks formation, canal transportation, postoperative pain and quality of obturation.In this way, the investigators propose a study in vivo performed, in patients from 8 to 18 years of age, therefore in large root canals. The protocol recommended by the manufacturer will be compared by means of a prospective randomized clinical trial, with the addition of the XP Endo finisher and with the protocol based on the initial apical file evaluating postoperative pain, exacerbation between the sessions, the quality of the obturation and periapical radiolucency repair. Considering that currently performing endodontic treatments using mechanized instruments is taught in undergraduate courses throughout the country, studies of this nature help the execution of a endodontics more critical and effective.
Detailed description
Infected root canal treatments will be performed in two sessions with a TF Adaptive system (Protocol recommended by manufacturer (Group Control) vs. Protocol based on the initial apical file). The root canals will be completed after 14 days. Patients will record postoperative pain during the follow-up period (7 days) using a Visual analogue scale (VAS) and the change in periapical radiolucency will be assessed by periapical index (PAI) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TF Adaptive (First Apical Binding File) | Experimental | Procedure: TF Adaptive (First Apical Binding File)Endodontic treatment(teeth with periapical periodontitis\&radiolucence).Local anesthesia (4%Articaine with1:100,000 epinephrine),isolation with rubber dam\&standard access cavity preparation.Using 2.5 %sodium hypochlorite,canal negotiation,glide path,coronal flaring with Sx(ProTaper),determining working length\&first apical binding file.Intervention: Root canal instrumentation:TF Adaptive system with enlargement of the root canal performed with up to 3 files larger than the diameter of the initial apical file. Irrigation2.5%NaOCl\&EDTA (Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, obturation: gutta-percha\&epoxy resin sealer. |
| TF Adaptive (Control) | Other | Procedure: TF Adaptive (Control)In the control group,endodontic treatment (teeth with periapical periodontitis\&radiolucence). Local anesthesia(4% Articaine with 1:100,000 epinephrine), isolation with rubber dam\&standard access cavity preparation. Using 2.5 % sodium hypochlorite, canal negotiation, determining working length\&glide path. Root canal instrumentation:TF Adaptive system according to the protocol recommended by the manufacturer.Irrigation 2.5% NaOCl \& EDTA(Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, the canals will be obturated with gutta-percha and epoxy resin sealer. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants who have in their mandibular or maxillary molar teeth apical periodontitis symptomatic or asymptomatic with apical radiolucence.
Key exclusion criteria (4 listed)
- Patients with medical history compromises outcomes
- Atresic and root canals
- Root canals with curvature greater than 30 degrees
- Previously performed endodontics treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TF Adaptive (First Apical Binding File)Procedure: TF Adaptive System NiTi (Nickel titanium) Endo File System (SybronEndo) The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor). Procedure: Instrumentation based on protocol of First Apical Binding File The enlargement of the root canal will be performed with three files larger than the diameter of the previously established initial apical file. | Procedure or surgery | TF Adaptive (First Apical Binding File) |
| TF Adaptive (Control)Also: TF Adaptive (Manufacturer's protocol)Procedure: TF Adaptive System NiTi (Nickel titanium)Endo File System The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor). Procedure: Instrumentation based on manufacturer's protocol The enlargement of the root canal will be performed according to the manufacturer's directions. | Procedure or surgery | TF Adaptive (Control) |
Primary outcome
Pain level
Time frame: 7 days
A Visual Analogue Scale VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.
1 secondary outcome
Periapical radiolucence Repair
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla C Gomes Moura, PhD principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TF Adaptive (First Apical Binding File) in people with Apical Periodontitis, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla C Gomes Moura, PhD (+55 34 99924 9586, camillahistologia@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.