NCT01728532

Brief 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. : + 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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

4 years

First QC Date

November 6, 2012

Last Update Submit

November 30, 2016

Conditions

Root Canal Obturation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (1)

  • Secondary outcomes

    2 years

Study Arms (2)

Pulp Canal Sealer (Kerr)

ACTIVE COMPARATOR

zinc oxide eugenol sealer

Device: Pulp Canal Sealer (Kerr)

PA0903

EXPERIMENTAL

type C implant according to ISO 7405:2008 and ISO 10993 guidelines.

Device: PA0903

Interventions

Pulp Canal Sealer (Kerr)DEVICE

permanent obturation of the root canal space with the aid of obturating points

Pulp Canal Sealer (Kerr)
PA0903DEVICE

Sealing performed by the dentist , coronal obturation placed after the canal obturation

PA0903

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • History of malignancy in the last 5 years.
  • 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.
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cabinet dentaire privé - 21, rue Fabre d'Églantine

Paris, France

Location

Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière

Paris, France

Location

School of Dentistry Cardiff University

Cardiff, United Kingdom

Location

Study Officials

  • Stéphane Simon, PhD

    Hôpital Pitié Salpetrière, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 20, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

FR(2)GB(1)