Trial Outcomes & Findings for Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial (NCT NCT04757753)
NCT ID: NCT04757753
Last Updated: 2025-06-26
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
160 participants
24 months post-treatment
2025-06-26
Participant Flow
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.
No randomization in case of screen failure or eligibility criteria noncompliance.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
83
|
|
Overall Study
COMPLETED
|
66
|
71
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Endodontic treatment failure
|
1
|
2
|
|
Overall Study
Tooth fracture/extraction
|
3
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PA1704
n=77 Participants
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=83 Participants
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.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 16.1 • n=77 Participants
|
46.3 years
STANDARD_DEVIATION 16.3 • n=83 Participants
|
48.5 years
STANDARD_DEVIATION 16.3 • n=160 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=77 Participants
|
46 Participants
n=83 Participants
|
77 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=77 Participants
|
37 Participants
n=83 Participants
|
83 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
11 Participants
n=77 Participants
|
13 Participants
n=83 Participants
|
24 Participants
n=160 Participants
|
|
Region of Enrollment
France
|
66 Participants
n=77 Participants
|
70 Participants
n=83 Participants
|
136 Participants
n=160 Participants
|
|
Tooth type
Incisor
|
8 Participants
n=77 Participants
|
2 Participants
n=83 Participants
|
10 Participants
n=160 Participants
|
|
Tooth type
Canine
|
3 Participants
n=77 Participants
|
5 Participants
n=83 Participants
|
8 Participants
n=160 Participants
|
|
Tooth type
Premolar
|
22 Participants
n=77 Participants
|
31 Participants
n=83 Participants
|
53 Participants
n=160 Participants
|
|
Tooth type
Molar
|
44 Participants
n=77 Participants
|
45 Participants
n=83 Participants
|
89 Participants
n=160 Participants
|
|
Number of canals to treat
1 canal
|
23 Participants
n=77 Participants
|
22 Participants
n=83 Participants
|
45 Participants
n=160 Participants
|
|
Number of canals to treat
2 canals
|
10 Participants
n=77 Participants
|
16 Participants
n=83 Participants
|
26 Participants
n=160 Participants
|
|
Number of canals to treat
3 canals
|
26 Participants
n=77 Participants
|
24 Participants
n=83 Participants
|
50 Participants
n=160 Participants
|
|
Number of canals to treat
4 canals
|
17 Participants
n=77 Participants
|
20 Participants
n=83 Participants
|
37 Participants
n=160 Participants
|
|
Number of canals to treat
5 canals
|
1 Participants
n=77 Participants
|
1 Participants
n=83 Participants
|
2 Participants
n=160 Participants
|
|
Type of endodontic treatment
Initial treatment
|
55 Participants
n=77 Participants
|
59 Participants
n=83 Participants
|
114 Participants
n=160 Participants
|
|
Type of endodontic treatment
Retreatment
|
22 Participants
n=77 Participants
|
24 Participants
n=83 Participants
|
46 Participants
n=160 Participants
|
|
Pulp diagnosis among initial treatments
Irreversible pulpitis
|
14 Participants
n=55 Participants • 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.
|
11 Participants
n=59 Participants • 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.
|
25 Participants
n=114 Participants • 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.
|
|
Pulp diagnosis among initial treatments
Necrotic pulp
|
28 Participants
n=55 Participants • 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.
|
31 Participants
n=59 Participants • 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.
|
59 Participants
n=114 Participants • 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.
|
|
Pulp diagnosis among initial treatments
Live pulp with endodontic treatment indication
|
13 Participants
n=55 Participants • 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.
|
17 Participants
n=59 Participants • 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.
|
30 Participants
n=114 Participants • 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.
|
|
Apical lesion
|
34 Participants
n=77 Participants
|
35 Participants
n=83 Participants
|
69 Participants
n=160 Participants
|
|
Symptomatic tooth
|
28 Participants
n=77 Participants
|
32 Participants
n=83 Participants
|
60 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 24 months post-treatmentPopulation: Per Protocol population: All patients for whom the efficacy rate of root canal obturation is measurable at 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.
Outcome measures
| Measure |
PA1704
n=67 Participants
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=73 Participants
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.
|
|---|---|---|
|
Efficacy Rate of Root Canal Obturation
Successfull treatment
|
61 Participants
|
66 Participants
|
|
Efficacy Rate of Root Canal Obturation
Unsuccessfull treatment
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 months post-treatmentPopulation: mITT Population (12 months)
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.
Outcome measures
| Measure |
PA1704
n=68 Participants
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=76 Participants
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.
|
|---|---|---|
|
Efficacy Rate of Root Canal Obturation
Successful treatment
|
63 Participants
|
69 Participants
|
|
Efficacy Rate of Root Canal Obturation
Unsuccessful treatment
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 months post-treatmentPopulation: mITT Population (6 months)
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.
Outcome measures
| Measure |
PA1704
n=71 Participants
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=79 Participants
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.
|
|---|---|---|
|
Efficacy Rate of Root Canal Obturation
Successfull Treatment
|
68 Participants
|
75 Participants
|
|
Efficacy Rate of Root Canal Obturation
Unsuccessfull Treatment
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24-months post-treatmentPopulation: mITT population (24 months)
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".
Outcome measures
| Measure |
PA1704
n=66 Participants
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=71 Participants
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.
|
|---|---|---|
|
Radiological Evaluation of the Canal Obturation
Sufficient radio-opacity
|
65 Participants
|
71 Participants
|
|
Radiological Evaluation of the Canal Obturation
Presence of at least one bubble (void) in the filling material
|
2 Participants
|
5 Participants
|
|
Radiological Evaluation of the Canal Obturation
If extruded material at T0, extruded material still presents in the periapical space
|
26 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
PA1704
n=76 Participants
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=80 Participants
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.
|
|---|---|---|
|
Postoperative Pain
Before endodontic treatment initiation
|
6.0 millimeters on the VAS
Standard Deviation 16.2
|
7.1 millimeters on the VAS
Standard Deviation 15.3
|
|
Postoperative Pain
Before session 2 initiation
|
1.9 millimeters on the VAS
Standard Deviation 3.3
|
0.1 millimeters on the VAS
Standard Deviation 0.4
|
|
Postoperative Pain
Post-operative pain At T0
|
2.6 millimeters on the VAS
Standard Deviation 5.8
|
3.6 millimeters on the VAS
Standard Deviation 8.4
|
|
Postoperative Pain
Post-operative pain At 12 hours
|
12.3 millimeters on the VAS
Standard Deviation 17.5
|
11.6 millimeters on the VAS
Standard Deviation 18.6
|
|
Postoperative Pain
Post-operative pain At 24 hours
|
6.5 millimeters on the VAS
Standard Deviation 11.9
|
8.8 millimeters on the VAS
Standard Deviation 16.6
|
|
Postoperative Pain
Post-operative pain At 48 hours
|
5.0 millimeters on the VAS
Standard Deviation 10.4
|
7.1 millimeters on the VAS
Standard Deviation 15.4
|
|
Postoperative Pain
Post-operative pain At 72 hours
|
3.8 millimeters on the VAS
Standard Deviation 11.3
|
2.9 millimeters on the VAS
Standard Deviation 7.8
|
|
Postoperative Pain
Post-operative pain At 7 days
|
0.5 millimeters on the VAS
Standard Deviation 1.1
|
0.7 millimeters on the VAS
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: From Day 0 to Day 7Population: ITT population
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.
Outcome measures
| Measure |
PA1704
n=77 Participants
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=83 Participants
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.
|
|---|---|---|
|
Use of Oral Pain Treatment
Reasons for using an oral pain treatment is a dental pain
|
24 Participants
|
25 Participants
|
|
Use of Oral Pain Treatment
Patients who used an oral pain treatment between T0 and D7
|
37 Participants
|
39 Participants
|
|
Use of Oral Pain Treatment
Reasons for using an oral pain treatment is an other pain
|
11 Participants
|
12 Participants
|
|
Use of Oral Pain Treatment
Reasons for using an oral pain treatment is both an oral and another pain
|
2 Participants
|
2 Participants
|
Adverse Events
PA1704
BioRoot™ RCS
Serious adverse events
| Measure |
PA1704
n=77 participants at risk
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=83 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Embolism pulmonary
|
1.3%
1/77 • Number of events 1 • 2 years post-treatment
|
0.00%
0/83 • 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Spinal Hernia
|
1.3%
1/77 • Number of events 1 • 2 years post-treatment
|
0.00%
0/83 • 2 years post-treatment
|
Other adverse events
| Measure |
PA1704
n=77 participants at risk
As a ready-to-use root canal sealer, PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
|
BioRoot™ RCS
n=83 participants at risk
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.
|
|---|---|---|
|
General disorders
Tooth fracture
|
3.9%
3/77 • Number of events 3 • 2 years post-treatment
|
3.6%
3/83 • Number of events 3 • 2 years post-treatment
|
|
General disorders
Tooth extraction
|
3.9%
3/77 • Number of events 3 • 2 years post-treatment
|
3.6%
3/83 • Number of events 3 • 2 years post-treatment
|
|
General disorders
Tooth pain
|
2.6%
2/77 • Number of events 2 • 2 years post-treatment
|
2.4%
2/83 • Number of events 2 • 2 years post-treatment
|
|
Nervous system disorders
Headache
|
11.7%
9/77 • Number of events 9 • 2 years post-treatment
|
8.4%
7/83 • Number of events 7 • 2 years post-treatment
|
|
Infections and infestations
Sinusitis
|
1.3%
1/77 • Number of events 1 • 2 years post-treatment
|
2.4%
2/83 • Number of events 2 • 2 years post-treatment
|
|
General disorders
Postoperative pain
|
1.3%
1/77 • Number of events 1 • 2 years post-treatment
|
3.6%
3/83 • Number of events 3 • 2 years post-treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place