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Therapeutic Irrigation Procedures to Treat Apical Periodontitis

NCT03987659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-18

No results posted yet for this study

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, this research 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. It is proposed that 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 to understand the process of healing following treatment of apical periodontitis at a molecular level, but also help to explore if there is therapeutic potential in enhancing dEMC release during NSRCT.

Conditions

  • Apical Periodontitis

Interventions

PROCEDURE

Irrigation protocols that promote release of dECMs

Irrigation protocols that promote release of dECMs

PROCEDURE

Conventional Irrigation protocols

Conventional Irrigation protocols

Sponsors & Collaborators

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Phillip L Tomson, PhD · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2024-03-25
Completion
2024-03-25

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03987659 on ClinicalTrials.gov