Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

Pulp Necrosis Clinical Trial

Official title:

Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881491
• Other study ID #: HSC20090181H
• Status: Completed
• Phase: Phase 0
• First received: April 13, 2009
• Last updated: February 4, 2016
• Start date: April 2009
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.

Description:

Recent case series have reported positive outcomes treating necrotic immature permanent teeth with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline). However, this method can result in considerable staining due to minocycline. In this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament as compared to a standard treatment (immediate apexification with MTA) in permanent teeth with necrotic pulps and immature root development. We hypothesize there will be no significant differences between radiographic measures of root development after treatment with either the double versus triple antibiotic paste, and that both methods will produce significantly greater increases in root length and width compared to standard treatment. The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 60 Years

Eligibility

Inclusion Criteria:

• diagnosis of pulpal necrosis with apical periodontitis

• patients 7-60 years of age

• maxillary or mandibular restorable single rooted immature permanent tooth with open apices

• acceptance of treatment plan with revascularization procedure

• healthy patient (ASA Class I or II physical status) with no systemic health problems

Exclusion Criteria:

• non-restorable teeth

• patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.

• child subjects unable to give assent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Pulp Necrosis

Intervention

Drug:
• Double Antibiotic Paste
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
• Triple Antibiotic Paste
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
• Mineral Trioxide Aggregate
standard material providing an apical barrier

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.	st radiograph taken at 1 month post-procedure completion; nd radiograph taken at 3 month post-procedure completion; rd radiograph taken at 6 month post-procedure completion	3 measurements over 6 months	No
Secondary	The secondary outcomes will be lack of clinical symptoms and crown staining.	st clinical assessment done at 1 month post-procedure completion; nd clinical assessment done at 3 month post-procedure completion; rd clinical assessment done at 6 month post-procedure completion	assessed over the 6 month study period	No