Therapeutic Irrigation Procedures to Treat Apical Periodontitis

NCT03987659 | Completed

• 1 other identifier: RG_19-062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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, 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

Outcome Measures

Primary Outcomes (1)

• Treatment Success Rate

  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.

  12 months

Secondary Outcomes (1)

• Profile of periradicular inflammatory mediators

  14 days

Study Arms (2)

Root Canal Treatment without dECMs release

ACTIVE COMPARATOR

Two visit non-surgical root canal therapy with conventional irrigation protocols

Procedure: Conventional Irrigation protocols

Root Canal Treatment with dECMs release

EXPERIMENTAL

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

Interventions

Irrigation protocols that promote release of dECMs PROCEDURE

Irrigation protocols that promote release of dECMs

Root Canal Treatment with dECMs release

Conventional Irrigation protocols PROCEDURE

Conventional Irrigation protocols

Root Canal Treatment without dECMs release

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Teeth in sextants with active periodontal disease (i.e. pocketing of ≤ 5 mm)
• Tooth unable to retain a rubber dam
• Teeth that have had previous endodontic treatment
• Root apex in close proximity to the maxillary sinus
• Patients who have had antimicrobial therapy within 3 months prior to the screening clinic
• Pregnant or breastfeeding women
• Do not have capacity to consent
• Patients that have systemic condition that would reduce immune function

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Birmingham Dental Hospital

Birmingham, B5 7EG, United Kingdom

Location

Related Publications (1)

• Virdee SS, Bashir N, Camilleri J, Cooper PR, Tomson PL. Exploiting Dentine Matrix Proteins in Cell-Free Approaches for Periradicular Tissue Engineering. Tissue Eng Part B Rev. 2022 Aug;28(4):707-732. doi: 10.1089/ten.TEB.2021.0074. Epub 2021 Oct 7.

  PMID: 34309453 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Phillip L Tomson, PhD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: October 1, 2019
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)