Root Canal Obturation
Conditions
Keywords
endodontic treatment, root canal sealer, periapical lesion
Brief summary
The study design is a multicentric randomized controlled non-inferiority trial. 160 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (80 in each group). The aim of the study is to assess the efficacy rate and the safety 2 years after root canal obturation undertaken using a ready-to-use calcium silicate sealer (PA1704) compared to the control calcium silicate sealer BioRoot™ RCS. Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRoot™ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months in both groups. The performance and safety of the sealer PA1704 will also be evaluated at 3.5 and 5 years after surgery. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.
Interventions
DEVICEready-to-use root canal sealer: PA1704
The participant will be treated with the ready-to-use root canal sealer (PA1704) in combination with gutta percha.
DEVICEroot canal sealer: BioRoot™ RCS
The participant will be treated with BioRoot™ RCS sealer in combination with gutta percha.
Sponsors
Septodont
Slb Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding will be done to the assessors who analyzed radiographs to reduce bias to healing assessment.
Intervention model description
Study subject (tooth) will be randomized in a 1:1 allocation ratio between the 2 treatment groups; the allocation will be stratified by the endodontic indication, i.e. primary or secondary root canal treatment, to enhance balance.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female (age ≥ 18 years) * Patient requiring a primary or a secondary root canal obturation on a single or multi-rooted tooth, * Patient geographically stable who can be followed by the same investigator site for 2 years, * Informed consent signed, * Patient with social protection
Exclusion criteria
* Patient with one or more documented contraindication to endodontic treatment, * Contraindication to the use of calcium silicate root canal sealer, such as an immature tooth or a known hypersensitivity to one component of the sealer formula, * Endodontic treatment on tooth with calcified root canal assessed radiographically, * Endodontic treatment on tooth with suspected perforation, * Patient with an uncontrolled systemic disease such as diabetes or thyroid disorders, or with an immunocompromised condition or who has undergone radiation therapy to the jaw. * Patient suffering from uncontrolled active periodontitis, not supported * Participation to another interventional clinical study at the same time, * Vulnerable subjects referred to in articles L.1121-5 to 8 and L.1122-1-2 of the Public Health Code and article 66 of Regulation (EU) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Rate of Root Canal Obturation | 24 months post-treatment | Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Rate of Root Canal Obturation | 12 months post-treatment | Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation. The efficacy rates was compared between the 2 groups at 12-months post-treatment. |
| Radiological Evaluation of the Canal Obturation | 24-months post-treatment | Radiological evaluation of the level of apical obturation and density. The level of apical obturation and density is measured by the Investigators on the retroalveolar radios, like the "Sufficient radio-opacity" of the ready-to-use root canal sealer under investigation, "Presence of at least one bubble (void) in the filling material", and "If extruded material at T0, extruded material still presents in the periapical space". |
| Postoperative Pain | Before endodontic treatment*; before session#2 initiation**; T0 (after canal obturation); 12; 24; 48; & 72h; 7 days after endodontic treatment. *Evaluation on same day for 1-session treatment; up to 18 days before if 2 sessions needed. **On same day. | The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm, from no pain to max pain) at different times after endodontic treatment (at the end of the root canal obturation, 12h postoperative, 24h, Day 2, Day 3, Day 7). The maximum pain felt will be compared between the 2 groups. To note: the endodontic treatment was performed in 2 sessions for some patients. For those patients, there is an additional pain evaluation done before the session 2. |
| Use of Oral Pain Treatment | From Day 0 to Day 7 | Patients reported the consumption of analgesic treatment in a diary. The percentage of patients who took oral pain medication will be compared between the 2 groups. |
Countries
Belgium, France
Contacts
PRINCIPAL_INVESTIGATORStéphane Simon, Pr, DDS
Cabinet dentaire Jeanne d'Arc - ROUEN (76000) - France
Participant flow
Recruitment details
The clinical investigation OPTIFILL has been conducted in a total of 7 investigational sites: 6 centers were in France and 1 center was in Belgium. Investigators are dental surgeons (endodontists or general dentists) from private practice offices or hospital. Recruitment was conducted over 9 months, between November 2020 and July 2021.
Pre-assignment details
No randomization in case of screen failure or eligibility criteria noncompliance.
Participants by arm
| Arm | Count |
|---|---|
| PA1704 As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals. | 77 |
| BioRoot™ RCS As a ready-to-use root canal sealer, BioRoot™ RCS is used in combination with gutta percha points for the permanent obturation of root canals. | 83 |
| Total | 160 |
Baseline characteristics
| Characteristic | PA1704 | Total | BioRoot™ RCS |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 16.1 | 48.5 years STANDARD_DEVIATION 16.3 | 46.3 years STANDARD_DEVIATION 16.3 |
| Apical lesion | 34 Participants | 69 Participants | 35 Participants |
| Number of canals to treat 1 canal | 23 Participants | 45 Participants | 22 Participants |
| Number of canals to treat 2 canals | 10 Participants | 26 Participants | 16 Participants |
| Number of canals to treat 3 canals | 26 Participants | 50 Participants | 24 Participants |
| Number of canals to treat 4 canals | 17 Participants | 37 Participants | 20 Participants |
| Number of canals to treat 5 canals | 1 Participants | 2 Participants | 1 Participants |
| Pulp diagnosis among initial treatments Irreversible pulpitis | 14 Participants | 25 Participants | 11 Participants |
| Pulp diagnosis among initial treatments Live pulp with endodontic treatment indication | 13 Participants | 30 Participants | 17 Participants |
| Pulp diagnosis among initial treatments Necrotic pulp | 28 Participants | 59 Participants | 31 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Belgium | 11 Participants | 24 Participants | 13 Participants |
| Region of Enrollment France | 66 Participants | 136 Participants | 70 Participants |
| Sex: Female, Male Female | 31 Participants | 77 Participants | 46 Participants |
| Sex: Female, Male Male | 46 Participants | 83 Participants | 37 Participants |
| Symptomatic tooth | 28 Participants | 60 Participants | 32 Participants |
| Tooth type Canine | 3 Participants | 8 Participants | 5 Participants |
| Tooth type Incisor | 8 Participants | 10 Participants | 2 Participants |
| Tooth type Molar | 44 Participants | 89 Participants | 45 Participants |
| Tooth type Premolar | 22 Participants | 53 Participants | 31 Participants |
| Type of endodontic treatment Initial treatment | 55 Participants | 114 Participants | 59 Participants |
| Type of endodontic treatment Retreatment | 22 Participants | 46 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 83 |
| other Total, other adverse events | 19 / 77 | 20 / 83 |
| serious Total, serious adverse events | 2 / 77 | 0 / 83 |
Outcome results
Primary
Efficacy Rate of Root Canal Obturation
Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation.
Time frame: 24 months post-treatment
Population: Per Protocol population: All patients for whom the efficacy rate of root canal obturation is measurable at 24 months post-treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PA1704 | Efficacy Rate of Root Canal Obturation | Successfull treatment | 61 Participants |
| PA1704 | Efficacy Rate of Root Canal Obturation | Unsuccessfull treatment | 6 Participants |
| BioRoot™ RCS | Efficacy Rate of Root Canal Obturation | Successfull treatment | 66 Participants |
| BioRoot™ RCS | Efficacy Rate of Root Canal Obturation | Unsuccessfull treatment | 7 Participants |
Comparison: The statistical analysis was done on the proportion difference of the treatment efficacy, defined on loose criteria, at 24 months, in PP population.p-value: 0.0390% CI: [-0.0074, 0.0087]Chi-squared, Corrected
Secondary
Efficacy Rate of Root Canal Obturation
Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation. The efficacy rates was compared between the 2 groups at 12-months post-treatment.
Time frame: 12 months post-treatment
Population: mITT Population (12 months)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PA1704 | Efficacy Rate of Root Canal Obturation | Successful treatment | 63 Participants |
| PA1704 | Efficacy Rate of Root Canal Obturation | Unsuccessful treatment | 5 Participants |
| BioRoot™ RCS | Efficacy Rate of Root Canal Obturation | Successful treatment | 69 Participants |
| BioRoot™ RCS | Efficacy Rate of Root Canal Obturation | Unsuccessful treatment | 7 Participants |
Secondary
Efficacy Rate of Root Canal Obturation
Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation. The efficacy rates was compared between the 2 groups at 6-months post-treatment.
Time frame: 6 months post-treatment
Population: mITT Population (6 months)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PA1704 | Efficacy Rate of Root Canal Obturation | Successfull Treatment | 68 Participants |
| PA1704 | Efficacy Rate of Root Canal Obturation | Unsuccessfull Treatment | 3 Participants |
| BioRoot™ RCS | Efficacy Rate of Root Canal Obturation | Successfull Treatment | 75 Participants |
| BioRoot™ RCS | Efficacy Rate of Root Canal Obturation | Unsuccessfull Treatment | 4 Participants |
Secondary
Postoperative Pain
The pain is assessed by patients in a diary using a Visual Analogue Scale (VAS: 0-100 mm, from no pain to max pain) at different times after endodontic treatment (at the end of the root canal obturation, 12h postoperative, 24h, Day 2, Day 3, Day 7). The maximum pain felt will be compared between the 2 groups. To note: the endodontic treatment was performed in 2 sessions for some patients. For those patients, there is an additional pain evaluation done before the session 2.
Time frame: Before endodontic treatment*; before session#2 initiation**; T0 (after canal obturation); 12; 24; 48; & 72h; 7 days after endodontic treatment. *Evaluation on same day for 1-session treatment; up to 18 days before if 2 sessions needed. **On same day.
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PA1704 | Postoperative Pain | Before endodontic treatment initiation | 6.0 millimeters on the VAS | Standard Deviation 16.2 |
| PA1704 | Postoperative Pain | Before session 2 initiation | 1.9 millimeters on the VAS | Standard Deviation 3.3 |
| PA1704 | Postoperative Pain | Post-operative pain At T0 | 2.6 millimeters on the VAS | Standard Deviation 5.8 |
| PA1704 | Postoperative Pain | Post-operative pain At 12 hours | 12.3 millimeters on the VAS | Standard Deviation 17.5 |
| PA1704 | Postoperative Pain | Post-operative pain At 24 hours | 6.5 millimeters on the VAS | Standard Deviation 11.9 |
| PA1704 | Postoperative Pain | Post-operative pain At 48 hours | 5.0 millimeters on the VAS | Standard Deviation 10.4 |
| PA1704 | Postoperative Pain | Post-operative pain At 72 hours | 3.8 millimeters on the VAS | Standard Deviation 11.3 |
| PA1704 | Postoperative Pain | Post-operative pain At 7 days | 0.5 millimeters on the VAS | Standard Deviation 1.1 |
| BioRoot™ RCS | Postoperative Pain | Post-operative pain At 7 days | 0.7 millimeters on the VAS | Standard Deviation 1.8 |
| BioRoot™ RCS | Postoperative Pain | Before endodontic treatment initiation | 7.1 millimeters on the VAS | Standard Deviation 15.3 |
| BioRoot™ RCS | Postoperative Pain | Post-operative pain At 24 hours | 8.8 millimeters on the VAS | Standard Deviation 16.6 |
| BioRoot™ RCS | Postoperative Pain | Before session 2 initiation | 0.1 millimeters on the VAS | Standard Deviation 0.4 |
| BioRoot™ RCS | Postoperative Pain | Post-operative pain At 72 hours | 2.9 millimeters on the VAS | Standard Deviation 7.8 |
| BioRoot™ RCS | Postoperative Pain | Post-operative pain At T0 | 3.6 millimeters on the VAS | Standard Deviation 8.4 |
| BioRoot™ RCS | Postoperative Pain | Post-operative pain At 48 hours | 7.1 millimeters on the VAS | Standard Deviation 15.4 |
| BioRoot™ RCS | Postoperative Pain | Post-operative pain At 12 hours | 11.6 millimeters on the VAS | Standard Deviation 18.6 |
Secondary
Radiological Evaluation of the Canal Obturation
Radiological evaluation of the level of apical obturation and density. The level of apical obturation and density is measured by the Investigators on the retroalveolar radios, like the Sufficient radio-opacity of the ready-to-use root canal sealer under investigation, Presence of at least one bubble (void) in the filling material, and If extruded material at T0, extruded material still presents in the periapical space.
Time frame: 24-months post-treatment
Population: mITT population (24 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PA1704 | Radiological Evaluation of the Canal Obturation | Sufficient radio-opacity | 65 Participants |
| PA1704 | Radiological Evaluation of the Canal Obturation | Presence of at least one bubble (void) in the filling material | 2 Participants |
| PA1704 | Radiological Evaluation of the Canal Obturation | If extruded material at T0, extruded material still presents in the periapical space | 26 Participants |
| BioRoot™ RCS | Radiological Evaluation of the Canal Obturation | Sufficient radio-opacity | 71 Participants |
| BioRoot™ RCS | Radiological Evaluation of the Canal Obturation | Presence of at least one bubble (void) in the filling material | 5 Participants |
| BioRoot™ RCS | Radiological Evaluation of the Canal Obturation | If extruded material at T0, extruded material still presents in the periapical space | 15 Participants |
Secondary
Use of Oral Pain Treatment
Patients reported the consumption of analgesic treatment in a diary. The percentage of patients who took oral pain medication will be compared between the 2 groups.
Time frame: From Day 0 to Day 7
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PA1704 | Use of Oral Pain Treatment | Patients who used an oral pain treatment between T0 and D7 | 37 Participants |
| PA1704 | Use of Oral Pain Treatment | Reasons for using an oral pain treatment is a dental pain | 24 Participants |
| PA1704 | Use of Oral Pain Treatment | Reasons for using an oral pain treatment is an other pain | 11 Participants |
| PA1704 | Use of Oral Pain Treatment | Reasons for using an oral pain treatment is both an oral and another pain | 2 Participants |
| BioRoot™ RCS | Use of Oral Pain Treatment | Reasons for using an oral pain treatment is both an oral and another pain | 2 Participants |
| BioRoot™ RCS | Use of Oral Pain Treatment | Patients who used an oral pain treatment between T0 and D7 | 39 Participants |
| BioRoot™ RCS | Use of Oral Pain Treatment | Reasons for using an oral pain treatment is an other pain | 12 Participants |
| BioRoot™ RCS | Use of Oral Pain Treatment | Reasons for using an oral pain treatment is a dental pain | 25 Participants |