Root Canal Treatment Outcome in Patients Under Bisphosphonate Therapy

• Sponsor: University of Bologna (Other)
• Overall Status: Completed
• CT.gov ID: NCT04399720
• Collaborator: (none)
• Enrollment: 111
• Actual Duration (Months): 107.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Root Canal Infection; Bisphosphonate-Associated Osteonecrosis; Periapical Abscess; Endodontically Treated Teeth	Procedure: Root canal treatment

Detailed Description

The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.

Root canal treatment was performed according previously reported operative protocols.

Study Design

• Study Type: Observational
• Actual Enrollment: 111 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Root Canal Treatment of Compromised Teeth as Alternative Treatment in Patients Under Bisphosphonate Therapy: 60-month Results of a Prospective Clinical Study
• Actual Study Start Date: Jan 7, 2009
• Actual Primary Completion Date: Dec 15, 2016
• Actual Study Completion Date: Dec 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
BPS group patients under Bisphosphonate therapy for at least 24 months	Procedure: Root canal treatment; Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique
healthy patients healthy patients not assuming with no previous Bisphosphonate assumption	Procedure: Root canal treatment; Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique

Outcome Measures

Primary Outcome Measures

1. health patients [5 years]

   assessment of periapical index (PAI)

Secondary Outcome Measures

1. Complications [5 years]

   extraction periapical re exacerbation during before the endline ( 5 years)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

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

Exclusion Criteria:

• inability to attend a recall hygien program

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fausto Zamparini, DDS,MS,PhD, University of Bologna
• ClinicalTrials.gov Identifier: NCT04399720
• Other Study ID Numbers: bifosfonendo
• First Posted: May 22, 2020
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fausto Zamparini, DDS,MS,PhD, University of Bologna: success rate; survival rate; endodontic treatment
• Additional relevant MeSH terms: Periapical Abscess; Osteonecrosis; Bisphosphonate-Associated Osteonecrosis of the Jaw; Tooth, Nonvital

Study Results

No Results Posted as of May 27, 2020