NCT04399720

Brief Summary

The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

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

January 7, 2009

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

7.9 years

First QC Date

May 20, 2020

Last Update Submit

May 23, 2020

Conditions

Keywords

success ratesurvival rateendodontic treatment

Outcome Measures

Primary Outcomes (1)

  • health patients

    assessment of periapical index (PAI)

    5 years

Secondary Outcomes (1)

  • Complications

    5 years

Study Arms (2)

BPS group

patients under Bisphosphonate therapy for at least 24 months

Procedure: Root canal treatment

healthy patients

healthy patients not assuming with no previous Bisphosphonate assumption

Procedure: Root canal treatment

Interventions

Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique

BPS grouphealthy patients

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Similar geographic provenience

You may qualify if:

  • Patients affected by endodontic disease and able to attend a hygiene recall program

You may not qualify if:

  • inability to attend a recall hygien program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Pirani C, Chersoni S, Montebugnoli L, Prati C. Long-term outcome of non-surgical root canal treatment: a retrospective analysis. Odontology. 2015 May;103(2):185-93. doi: 10.1007/s10266-014-0159-0. Epub 2014 Jun 8.

  • Prati C, Pirani C, Zamparini F, Gatto MR, Gandolfi MG. A 20-year historical prospective cohort study of root canal treatments. A Multilevel analysis. Int Endod J. 2018 Sep;51(9):955-968. doi: 10.1111/iej.12908. Epub 2018 Mar 7.

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the JawPeriapical AbscessTooth, Nonvital

Condition Hierarchy (Ancestors)

OsteonecrosisBone DiseasesMusculoskeletal DiseasesJaw DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAbscessSuppurationInfectionsPeriapical PeriodontitisPeriapical DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisDental Pulp DiseasesTooth Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS,MS,PhD

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 22, 2020

Study Start

January 7, 2009

Primary Completion

December 15, 2016

Study Completion

December 15, 2017

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share