Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.

Root Canal Obturation Clinical Trial

— BioRoot  

Official title:

Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247138
• Other study ID #: BIOR 2021-04
• Status: Recruiting
• Start date: February 18, 2022
• Est. completion date: July 1, 2029

Study information

• Verified date: April 2024
• Source: Septodont
• Contact: Farid Benabdallah, MD
• Phone: +33 (0)149767328
• Email: fbenabdallah[@]septodont.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment. Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: July 1, 2029
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient, male or female, > 18 years of age at the time of inclusion in the study.
• Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago.
• All roots of the investigational teeth were treated with BioRootTM RCS.
• Having a documented retro-alveolar radiography immediately after root canal obturation.
• Patient affiliated or beneficiary of a social security system.
• Patient has signed his/her informed consent form.

Exclusion Criteria:

• History of malignant tumors in the 5 years prior to the root canal treatment.
• Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.).
• Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS.
• The Root canal treatment with BioRootTM RCS is on a wisdom tooth.
• Tooth presenting an advanced periodontal disease (parodontal pocket = 5mm or bone loss = 50%).

Related Conditions & MeSH terms

• Root Canal Obturation

Intervention

Device:
• BioRootTM RCS
BioRoot™ RCS is a hydrophilic mineral root canal sealer prepared from the mixture of a powder part and a liquid part. BioRoot™ RCS is a class III implantable medical device. This device is intended to be used in dentistry for permanent obturation of root canals of permanent and mature teeth with adjunction of gutta-percha points. Exposure to the sealer BioRootTM RCS starts from the day when the root canal treatment is performed until the end of individual observational period or the removal of the sealer in case of extraction or retreatment, if this event occurs before the end of individual observational period.

Locations

Country	Name	City	State
France	Cabinet dentaire	Dijon
France	Cabinet Dentaire	Levallois-Perret	Perret
France	Cabinet Dentaire	Muizon
France	Cabinet dentaire	Muizon
France	Cabinet dentaire	Paris
France	Cabinet dentaire	Paris
France	Cabinet dentaire	Plerin
France	Cabinet dentaire	Saint-Amand-sur-Sèvre
France	Cabinet dentaire	Sezanne
France	Cabinet dentaire	Sézanne
France	Cabinet Medical	Villiers-sur-Marne

Sponsors (3)

Lead Sponsor	Collaborator
Septodont	EndoData, ReCOL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and radiological performance impact of the endodontic treatment at 5 years.	The "success" and "failure" of the 5-year clinical and radiological performance impact of the endodontic treatment.	At 5 years post treatment
Secondary	Clinical and radiological performance impact of the endodontic treatment at 10 years.	The "success" and "failure" of the 10-year clinical and radiological performance impact of the endodontic treatment.; Absence of pain; Absence of clinical evidence of infection, inflammation or swelling; Normal periodontal ligament space (PAI score = 2); • "failure" of the endodontic treatment occur if the investigational tooth met one of the following criteria: had been extracted for endodontic reasons since the root canal filling; Had been retreated since the root canal filling; Had undergone a periapical surgery since the root canal treatment; Presence of pain; Presence of clinical evidence of infection, inflammation or swelling; PAI score = 3	At 10 years post treatment
Secondary	Evaluation of the need of treatment or retreatment at 5 and 10 years.	"The "success" and "failure" of the endodontic treatment at 5 and 10 years according treatment or retreatment.	At 5 and 10 Years post treatment
Secondary	Assessment of the "tooth functional retention" at 5 and 10 years.	The success and failure of the "tooth functional retention" at 5 and 10 years after Root Canal Treatment with BioRoot™ RCS.	At 5 and 10 Years post treatment
Secondary	The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment.	The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment "Not resorbable once hardened", "Not retractable over the years" and "Radiopaque" will be evaluated in patients with retro-alveolar radiographs at the follow-up consultation (in parallel of the baseline consultation). The technical characteristics are defined as follows: no resorption of the filling cement in the root, detectable on radiography; dense and homogeneous filling, limited to the canal; a filling with the maintenance of the canal anatomy	At 5 and 10 Years post treatment
Secondary	The ease of use and insertion of BioRootTM RCS in the canal.	The ease of use and insertion of BioRootTM RCS in the canal will be evaluated with the score obtained on the Visual Analog Scale: score from 0 (Not at all) to 10 (Certainly Yes).	At 5 years post treatment
Secondary	The Investigator overall satisfaction of the experience with BioRootTM RCS.	The Investigator overall satisfaction of the experience with BioRootTM RCS will be evaluated at 5 and 10 years after Root Canal Obturation with the score obtained on the Visual Analog Scale: score from 0 (Not at all) to 10 (Certainly Yes).	At 5 and 10 Years post treatment
Secondary	The post-obturation adverse device effects.	The post-obturation adverse device effects will be evaluated with the list of adverse events occurring between the date of the root canal filling and the 5-year visit and between the 5-year visit and the 10-year visit.	At baseline visit, 5 and 10 years post treatment