Root Canal ObturationPA0903NCT01728532
Open, Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer
A study testing Pulp Canal Sealer (Kerr) and PA0903 in people with Root Canal Obturation, run by Ascopharm Groupe Novasco at 3 sites in 2 countries.
Trial summary
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer SPONSOR: SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Root Canal Obturation
- What is being tested?
- Pulp Canal Sealer (Kerr) and PA0903
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2012to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >18 years old
- provide signed, informed consent.
- be affiliated to social security.
- In addition, the subjects must fulfill all of the following criteria for root canal sealer treatment:
- Permanent mature single rooted teeth : maxillary incisors, mandibular incisor with only one canal, upper and lower canine, upper and lower premolars with only one canal
- Permanent mature mandibular molars Pulp status
Show all 10Show fewer
- Vital pulp that needs pulpectomy without clinical and/or radiological findings of apical periodontitis.
- Irreversible pulpitis with or without pain
- Non infected tooth that positively responds of pulp vitality test Or necrotic pulp with and without radiographic signs of apical pathosis Periodontal status
- No active periodontal disease
Who cannot join
- History of malignancy in the last 5 years.
- Systemic disease not stabilized within 1 month before the Inclusion Visit (e.g., diabetes, thyroid malfunction, uncontrolled autoimmune disease) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or condition incompatible with the frequent assessments needed by the study.
- Risk A cardiopathies
- Known hypersensitivity to one of the components of the study or procedural medications.
- Presence or history of severe systemic allergy.
- Presence or history of drug addiction or alcohol abuse.
Show all 23Show fewer
- Patient who has participated in a clinical trial with a new active substance during the month before study entry.
- Participation in another clinical study at the same time as the present study.
- Known pregnancy or lactation at study entry.
- Patients with legal protection
- Specific criteria relative to root canal sealing are:
- Extreme curvature of the canals
- Dilacerations
- Root dilacerations and sharp apical curvature for mandibular molars
- Superimposition of mesial canals for mandibular molar
- Large peri-apical radiolucencies
- Periodontal disease
- Not primary endodontic treatment
- Perforated root canals
- Supracrestal iatrogenic perforation
- Inadequate or insufficient periodontal support
- Combined endo-periodontal lesion
- Loss of tooth structure (Coronal decay and/or concomitant root decay) compromising the tooth's maintenance on the dental arch)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Cabinet dentaire privé - 21, rue Fabre d'Églantine
Paris
Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière
Paris
About this study
Official title: Open, Randomized Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer
SPONSOR:
SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91
Reference protocol: 11/001
PRODUCT NAME: PA0903
MEDICAL DEVICE:
Class III: Root canal sealer Dose: not applicable Application : one single time
DEVELOPMENTAL PHASE: not applicable (medical device class III)
Read the detailed description
METHODOLOGY:
This study is performed only in adults who required a non-surgical root canal obturation. The studied indication is the root canal sealing.
This multi-centre and open-label study comprises two groups corresponding to tested root canal sealer (a reference product and investigational product). Randomization is required.
Investigational product that is a dental cement based on biosilicate technology (PA0903) will be applied with lateral compaction or single cone technique. On the contrary, reference product that is a zinc oxide-eugenol used in dental practice (Pulp Canal Sealer) will be applied with a single wave technique.
Study start: 01/12/11
Inclusion period: 24 months
Study duration: 2 years after the end of inclusion period
OBJECTIVES: The trial objective is to illustrate the clinical and radiographic outcome of PA0903 in the described indication.
Primary objectives:
The primary objective is to evaluate: clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful . Moreover, all cases in which Strindberg's criteria if they are suitable were not fulfilled were judged as unsuccessful. A follow-up of two years is described as the predictive time of success.
Secondary objective:
The secondary objectives are to evaluate the following criteria and in an indicative way, to compare them between patients receiving the PA0903 and those receiving the reference product:
- The success rate at each time point and also the components of this composite variable (i.e. pain and Healing process for total class (vital teeth and necrotic teeth) of endodontic status of teeth).
In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as described below :
At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in comparison with V0 associated with Strindberg's criteria suitable.
At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with V2 associated with Strindberg's criteria suitable.
- the Healing process associated with PA0903 application in each endodontic status
- the handling, consistency and physical characteristics of PA0903
- the longevity and safety of the product associated with PA0903 after two years.
TRIAL POPULATION AND NUMBER OF PATIENTS: about 60 patients will have to be included in the study, 20 by center with a ratio 2 (PA0903): 1 (reference). Adults will be included without gender distinction.
Coordinating center Endodotontic service of Pitié Salpétrière Pitié Salpétrière Hospital 75634 Paris Cedex 13 France
DURATION OF TREATMENT:
The product is applied on D0 (inclusion) of the study. The follow-up period includes 2 years with 4 visits: Visit 1(Week 2), Visit 2 (Month 6), Visit 3 (Year 1) and Visit 4 (Year 2).
- Conditions
- Root Canal Obturation
- Being tested
- Pulp Canal Sealer (Kerr), PA0903
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulp Canal Sealer (Kerr)Device
permanent obturation of the root canal space with the aid of obturating points
PA0903Device
Sealing performed by the dentist , coronal obturation placed after the canal obturation
| Study group | Role | What they receive |
|---|---|---|
| Pulp Canal Sealer (Kerr) | Active comparator | zinc oxide eugenol sealer Receives: Device: Pulp Canal Sealer (Kerr) |
| PA0903 | Experimental | type C implant according to ISO 7405:2008 and ISO 10993 guidelines. Receives: Device: PA0903 |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and radiographic outcome of PA0903 as root canal sealer
to evaluate clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful .A follow-up of two years is described as the predictive time of success.
Measured: 2 years
Secondary outcomes (1)
Secondary outcomes
- The success rate at each time point and also the components of this composite variable (i.e. pain and Healing process for total class (vital teeth and necrotic teeth) of endodontic status of teeth).
In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as described below :
At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in comparison with V0 associated with Strindberg's criteria suitable.
At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with V2 associated with Strindberg's criteria suitable.
- the Healing process associated with PA0903 application in each endodontic status
- the handling, consistency and physical characteristics of PA0903
- the longevity and safety of the product associated with PA0903 after two years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal ObturationStudies 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascopharm Groupe Novasco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Simon, PhD, Principal investigator, Hôpital Pitié Salpetrière, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728532
- Sponsor's protocol ID
- 11/001
- Acronym
- PA0903
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2012
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer
- ClinicalTrials.gov ID
- NCT01728532
- Acronym / sponsor ID
- PA0903 / 11/001
- Conditions
- Root Canal Obturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ascopharm Groupe NovascoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Nov 2012 (estimated)
- 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.
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer
SPONSOR:
SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91
Reference protocol: 11/001
PRODUCT NAME: PA0903
MEDICAL DEVICE:
Class III: Root canal sealer Dose: not applicable Application : one single time
DEVELOPMENTAL PHASE: not applicable (medical device class III)
Detailed description
METHODOLOGY:
This study is performed only in adults who required a non-surgical root canal obturation. The studied indication is the root canal sealing.
This multi-centre and open-label study comprises two groups corresponding to tested root canal sealer (a reference product and investigational product). Randomization is required.
Investigational product that is a dental cement based on biosilicate technology (PA0903) will be applied with lateral compaction or single cone technique. On the contrary, reference product that is a zinc oxide-eugenol used in dental practice (Pulp Canal Sealer) will be applied with a single wave technique.
Study start: 01/12/11
Inclusion period: 24 months
Study duration: 2 years after the end of inclusion period
OBJECTIVES: The trial objective is to illustrate the clinical and radiographic outcome of PA0903 in the described indication.
Primary objectives:
The primary objective is to evaluate: clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful . Moreover, all cases in which Strindberg's criteria if they are suitable were not fulfilled were judged as unsuccessful. A follow-up of two years is described as the predictive time of success.
Secondary objective:
The secondary objectives are to evaluate the following criteria and in an indicative way, to compare them between patients receiving the PA0903 and those receiving the reference product:
- The success rate at each time point and also the components of this composite variable (i.e. pain and Healing process for total class (vital teeth and necrotic teeth) of endodontic status of teeth).
In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as described below :
At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in comparison with V0 associated with Strindberg's criteria suitable.
At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with V2 associated with Strindberg's criteria suitable.
- the Healing process associated with PA0903 application in each endodontic status
- the handling, consistency and physical characteristics of PA0903
- the longevity and safety of the product associated with PA0903 after two years.
TRIAL POPULATION AND NUMBER OF PATIENTS: about 60 patients will have to be included in the study, 20 by center with a ratio 2 (PA0903): 1 (reference). Adults will be included without gender distinction.
Coordinating center Endodotontic service of Pitié Salpétrière Pitié Salpétrière Hospital 75634 Paris Cedex 13 France
DURATION OF TREATMENT:
The product is applied on D0 (inclusion) of the study. The follow-up period includes 2 years with 4 visits: Visit 1(Week 2), Visit 2 (Month 6), Visit 3 (Year 1) and Visit 4 (Year 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulp Canal Sealer (Kerr) | Active comparator | Device: Pulp Canal Sealer (Kerr)zinc oxide eugenol sealer |
| PA0903 | Experimental | Device: PA0903type C implant according to ISO 7405:2008 and ISO 10993 guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female >18 years old
- provide signed, informed consent.
- be affiliated to social security.
- In addition, the subjects must fulfill all of the following criteria for root canal sealer treatment:
- Permanent mature single rooted teeth : maxillary incisors, mandibular incisor with only one canal, upper and lower canine, upper and lower premolars with only one canal
Key exclusion criteria (23 listed)
- History of malignancy in the last 5 years.
- Systemic disease not stabilized within 1 month before the Inclusion Visit (e.g., diabetes, thyroid malfunction, uncontrolled autoimmune disease) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or condition incompatible with the frequent assessments needed by the study.
- Risk A cardiopathies
- Known hypersensitivity to one of the components of the study or procedural medications.
- Presence or history of severe systemic allergy.
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 |
|---|---|---|
| Pulp Canal Sealer (Kerr)permanent obturation of the root canal space with the aid of obturating points | Device | Pulp Canal Sealer (Kerr) |
| PA0903Sealing performed by the dentist , coronal obturation placed after the canal obturation | Device | PA0903 |
Primary outcome
clinical and radiographic outcome of PA0903 as root canal sealer
Time frame: 2 years
to evaluate clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful .A follow-up of two years is described as the predictive time of success.
1 secondary outcome
Secondary outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
Related trials for Root Canal Obturation
Recruiting
Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
Pulpectomy, Pulpitis - Irreversible
Not yet recruiting
Diagnostic Accuracy of a Deep Learning Framework for Automated Evaluation of Root Canal Obturation Quality From Periapical Radiographs
Root Canal Treatment, Obturation Quality
Active, not recruiting
Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial
Root Canal Obturation
Active, not recruitingObservational study
Tooth Retention After Root Canal Treatment With Endomethasone N
Dental Root Canal Obturation
Active, not recruitingObservational study
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.
Root Canal Obturation
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.
Stéphane Simon, PhD principal investigator
Hôpital Pitié Salpetrière, Paris, France
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulp Canal Sealer (Kerr) and PA0903 in people with Root Canal Obturation, run by Ascopharm Groupe Novasco at 3 sites in 2 countries.
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 10 inclusion and 23 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: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical and radiographic outcome of PA0903 as root canal sealer (time frame: 2 years). 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 1 Dec 2016; AzTrials last refreshed its copy on 5 Nov 2026.