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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01790-39-PP | Other Identifier | French National Agency of Medicines and Health products | |
| CIV-BE-20-10-034945 | Other Identifier | Belgium Federal Agency for Medicines and Health products |
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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ready-to-use root canal sealer: PA1704 | Experimental | PA1704 is used in combination with gutta percha points for the permanent obturation of root canals. |
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| root canal sealer: BioRoot™ RCS | Other | BioRoot™ RCS is used in combination with gutta percha points for the permanent obturation of root canals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ready-to-use root canal sealer: PA1704 | Device | The participant will be treated with the ready-to-use root canal sealer (PA1704) in combination with gutta percha. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Simon, Pr, DDS | Cabinet dentaire Jeanne d'Arc - ROUEN (76000) - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc, Département de Médecine Dentaire et de Stomatologie | Brussels | 1200 | Belgium | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40491343 | Result | Simon S, Beauquis J, Colombel H, Dorn A, Marchi V, Robert S, Souleau G, Ravalec N, Huguet-Jaime F, Chazaud K, Serandour AL, Ournid N, Leprince JG. Clinical efficacy of root canal treatment at 2 years using a new ready-to-use injectable calcium silicate-based sealer: A multicentric randomised controlled trial. Int Endod J. 2025 Sep;58(9):1420-1432. doi: 10.1111/iej.14265. Epub 2025 Jun 10. |
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No randomization in case of screen failure or eligibility criteria noncompliance.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2023 |
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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.
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Blinding will be done to the assessors who analyzed radiographs to reduce bias to healing assessment.
| root canal sealer: BioRoot™ RCS | Device | The participant will be treated with BioRoot™ RCS sealer in combination with gutta percha. |
|
| 12 months post-treatment |
| 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. | 6 months post-treatment |
| 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". | 24-months post-treatment |
| 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. | 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. |
| 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. | From Day 0 to Day 7 |
| Centre de santé dentaire Flandre |
| Paris |
| 75019 |
| France |
| Cabinet dentaire | Rennes | 35000 | France |
| Cabinet dentaire Jeanne d'Arc | Rouen | 76000 | France |
| Cabinet dentaire | Saint-Grégoire | 35760 | France |
| COMPLETED |
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| NOT COMPLETED |
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All the randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Tooth type | Description of teeth to be treated at baseline | Count of Participants | Participants |
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| Number of canals to treat | Count of Participants | Participants |
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| Type of endodontic treatment | Count of Participants | Participants |
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| Pulp diagnosis among initial treatments | Information regarding the diagnosis of the tooth pulp is given for initial treatment subpopulation only, since there is no pulp anymore in the retreatment subpopulation. | Count of Participants | Participants |
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| Apical lesion | Number of patients with an apical lesion before the treatment | Count of Participants | Participants |
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| Symptomatic tooth | Number of patients with a symptomatic tooth before the treatment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per Protocol population: All patients for whom the efficacy rate of root canal obturation is measurable at 24 months post-treatment. | Posted | Count of Participants | Participants | 24 months post-treatment |
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| 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. | mITT Population (12 months) | Posted | Count of Participants | Participants | 12 months post-treatment |
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| 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. | mITT Population (6 months) | Posted | Count of Participants | Participants | 6 months post-treatment |
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| 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". | mITT population (24 months) | Posted | Count of Participants | Participants | 24-months post-treatment |
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| 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. | ITT population | Posted | Mean | Standard Deviation | millimeters on the VAS | 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. |
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| 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. | ITT population | Posted | Count of Participants | Participants | From Day 0 to Day 7 |
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2 years post-treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 77 | 2 | 77 | 19 | 77 |
| EG001 | 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. | 0 | 83 | 0 | 83 | 20 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism pulmonary | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment | Embolism pulmonary, not related to the Investigational Medical Device |
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| Spinal Hernia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment | Surgery to treat a spinal hernia, not related to the investigational medical device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth fracture | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Tooth extraction | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Tooth pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Postoperative pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations - Medical Affairs Department | SEPTODONT | +33 1 49 76 70 00 | clinical-operations@septodont.com |
| Apr 15, 2024 |
| Prot_SAP_000.pdf |
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| France |
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| Canine |
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| Premolar |
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| Molar |
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