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Therapeutic Irrigation Procedures to Treat Apical Periodontitis (TIPTAP)

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ClinicalTrials.gov Identifier: NCT03987659
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

Brief Summary:

Apical periodontitis is a dental infection which develops around the root of a tooth and affects ~4-6% of the UK population. Current treatment strategies focus solely on removing bacteria from within the root canal space during Non-Surgical Root Canal Treatment (NSRCT). Despite radical improvements in techniques available to disinfect canals, over the last 2-3 decades there has been no proportionate improvement in success rates, with ~20% of cases failing to demonstrate complete healing following NSRCT. Over time this has placed significant burden on public resources as evidenced by increased referrals to dental hospitals, extensive waiting lists and increased use of anti-microbials.

It has long been known numerous bioactive molecules (dentine extracellular matrix components [dECM]) exist within the structure of the dentine. In a laboratory setting, they have demonstrated significant antibacterial properties and the ability to induce the functional processes of dental tissue repair. Through a different irrigation procedure, our group have optimised methods for releasing dECMs during NSRCT and hypothesise this intervention could potentially promote a reduction in inflammation, improve healing and lead to more favourable outcomes for patients suffering from apical periodontitis, a concept which has not yet been investigated. We propose to test this hypothesis at the Birmingham Dental Hospital by comparing clinical/radiographic signs of periradicular healing, and the molecular inflammatory response, in patients undergoing standard NSRCT (control arm) to those who having NSRCT with an irrigant regime that promotes release of dEMCs (intervention arm).

Data generated from this randomised controlled pilot study will not only help us understand the process of healing following treatment of apical periodontitis at a molecular level, but also help us explore if there is therapeutic potential in enhancing dEMC release during NSRCT.


Condition or disease Intervention/treatment Phase
Apical Periodontitis Procedure: Irrigation protocols that promote release of dECMs Procedure: Conventional Irrigation protocols Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Pilot Study to Determine the Effect of Irrigation Techniques Used to Enhance the Release of Endogenous Signalling Molecules From Dentine Matrix to Treat Apical Periodontitis
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Arm Intervention/treatment
Active Comparator: Root Canal Treatment without dECMs release
Two visit non-surgical root canal therapy with conventional irrigation protocols
Procedure: Conventional Irrigation protocols
Conventional Irrigation protocols

Experimental: Root Canal Treatment with dECMs release
Two visit non-surgical root canal treatment with irrigation protocols that optimise release of soluble dentine extracellular matrix components (dEMCs)
Procedure: Irrigation protocols that promote release of dECMs
Irrigation protocols that promote release of dECMs




Primary Outcome Measures :
  1. Treatment Success Rate [ Time Frame: 12 months ]
    Clinical/radiographic information (i.e. absence of pain and resolution of swelling, pain on percussion / palpation and reduction in size of periradicular lesion) will be collected at baseline and again at a 12 month follow-up. Treatment success will be determined based on criteria outlined by the European Society of Endodontology (ESE) Quality Guidelines for NSRCT (2006). In these criteria, outcomes are defined as being "favourable" (absence of pain, swelling and other symptoms, no sinus tract, no loss of function and radiological evidence of a complete healing), "uncertain" (absence of pain, swelling and other symptoms, no sinus tract, no loss of function and radiographic evidence of some healing) and finally "unfavourable" (tooth associated with clinical signs and symptoms of infection such as pain and swelling, sinus tract, loss of function and no radiographic evidence of healing.


Secondary Outcome Measures :
  1. Profile of periradicular inflammatory mediators [ Time Frame: 14 days ]
    To analyse inflammatory mediator activity. Periradicular tissue fluid will be retrieved from the peri-radicular tissues through the root canal with a paper point and the concentration of various inflammatory mediators will be quantified via a multiplex bead-based assay technique.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients diagnosed with apical periodontitis
  • Single rooted permanent teeth
  • Medically fit
  • Adult patients (≥ 18)
  • Voluntarily consent to partake in the study

Exclusion Criteria:

  • Teeth in sextants with active periodontal disease (i.e. pocketing of ≤ 5 mm)
  • Tooth unable to retain a rubber dam
  • Teeth with previous root fillings
  • Teeth diagnosed with non-endodontic pathology

    --Teeth where the adjacent teeth have metal posts or dental implants

  • Root apex in close proximity to the maxillary sinus
  • Patients who have had antimicrobial therapy within 3 months prior to screening
  • Pregnant or breastfeeding women
  • Do not have capacity to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987659


Contacts
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Contact: Phillip L Tomson, PhD +44(0)1214665173 p.l.tomson@bham.ac.uk
Contact: Satnam S Virdee, BDS +44(0)1214665173 s.s.virdee.1@bham.ac.uk

Locations
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United Kingdom
Birmingham Dental Hospital Not yet recruiting
Birmingham, United Kingdom, B5 7EG
Contact: Phillip L Tomson, PhD    +44(0)1214665173    p.l.tomson@bham.ac.uk   
Sponsors and Collaborators
University of Birmingham

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03987659     History of Changes
Other Study ID Numbers: RG_19-062
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases