Comparing two ways of cleaning root canals to see which better reduces harmful bacteria during dental treatment
| ISRCTN | ISRCTN11332195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11332195 |
| Sponsor | Mustansiriyah University |
| Funder | Investigator initiated and funded |
- Submission date
- 21/11/2025
- Registration date
- 25/11/2025
- Last edited
- 25/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to compare the effectiveness of multi-step versus single-step root canal irrigation protocols in reducing bacterial DNA and RNA levels.
Who can participate?
Eligible participants are patients requiring root canal treatment who meet inclusion criteria and provide informed consent.
What does the study involve?
Participants will receive root canal treatment using one of two irrigation methods. Bacterial samples will be collected before and after treatment to assess bacterial load reduction.
What are the possible benefits and risks of participating?
Participants may benefit from optimized root canal treatment techniques. Risks include mild discomfort or sensitivity related to standard dental procedures.
Where is the study run from?
The study is conducted at the College of Dentistry, Mustansiriyah University (Iraq)
When is the study starting and how long is it expected to run for?
The study starts 08/05/2024, last enrolment 10/04/2025 and completed 18/12/2025 .
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
The main contact is Omar Talib Khaleefah, reachable at omr_ta@yahoo.com for any study-related questions.
Contact information
Public, Scientific, Principal investigator
Ramadi, Anbar Governorate
Ramadi
31001
Iraq
 ORCID ID |
0000-0002-8192-2933 |
|---|---|
| Phone | +9647816788826 |
| omr_ta@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel superiority, double-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Comparative evaluation of multi-step versus single-step root canal irrigation protocols on reduction of bacterial DNA and RNA levels: a randomized controlled clinical trial |
| Study objectives | To compare the efficacy of conventional multi-step irrigants (sodium hypochlorite and EDTA) against single-step Triton irrigants in reducing bacterial DNA and RNA levels within root canals. |
| Ethics approval(s) |
Approved 01/05/2024, College of Dentistry Research Ethics Committee (Mustansiriyah University, Baghdad, -, Iraq; -; mucodrec@gmail.com), ref: REC198 |
| Health condition(s) or problem(s) studied | Maxillary central incisors with necrotic pulp (non-responsive to sensitivity testing), asymptomatic apical periodontitis |
| Intervention | Procedure and Bacterial Sampling: 28 patients included, All teeth follow strict aseptic measures, including plaque removal and disinfection with 30% H2O2 followed by 2.5% NaOCl, which is then inactivated with 5% sodium thiosulfate. Control samples using sterile paper points verify the sterility of the disinfected tooth surface before anesthesia and isolation. After access cavity preparation and complete removal of caries and restoration, the cavity undergoes the same disinfection protocol, and another control sample is obtained. Patients are randomly assigned to two groups based on irrigation technique: Group 1: Multi-Step (NaOCl/EDTA, n=14) Group 2: Single-Step (Triton, n=14) Before the first sampling (S1), a K-file #15 confirms working length using radiographs and an apex locator. Three sterile paper points are consecutively introduced to full canal length and retained for 60 seconds. Chemomechanical preparation follows using modified NiTi instruments, with irrigation according to group assignment and irrigants neutralized by 5% sodium thiosulfate. The second sampling (S2) is conducted immediately after chemomechanical preparation using the same sampling method. All samples are collected for bacterial DNA and RNA analysis. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 18/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 28 |
| Total final enrolment | 28 |
| Key inclusion criteria | 1. Maxillary central incisors with necrotic pulp (non-responsive to sensitivity testing) 2. Asymptomatic apical periodontitis, confirmed by periapical radiographs 3. Patients aged 18–60 years |
| Key exclusion criteria | 1. Symptomatic teeth (pain, tenderness, swelling) 2. Immature roots 3. Antibiotic use within 3 months 4. Systemic disease 5. Inability to isolate with a rubber dam 6. Periodontal pockets >3 mm 7. Root fractures 8. Severe decay |
| Date of first enrolment | 08/05/2024 |
| Date of final enrolment | 10/04/2025 |
Locations
Countries of recruitment
- Iraq
Study participating centre
10052
Iraq
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Omar Talib Khaleefah (omr_ta@yahoo.com) |
Editorial Notes
24/11/2025: Trial's existence confirmed by College of Dentistry Research Ethics Committee.
