Effect of XP-endo finisher on microbial root canal flora after using multiple irrigation protocols
| ISRCTN | ISRCTN13986591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13986591 |
- Submission date
- 16/04/2025
- Registration date
- 28/04/2025
- Last edited
- 28/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study focuses on root canal infections, which are caused by bacteria and can lead to serious dental problems. The goal is to find the best way to clean the root canal using different solutions. Researchers are comparing three methods: using 5.25% sodium hypochlorite alone, combining it with 2% chlorhexidine, and combining it with QMIX. They are also looking at whether using a special tool called the XP-endo Finisher makes a difference.
Who can participate?
People who are between 20 and 40 years old, have no preoperative pain, have necrotic teeth, have a periapical radiolucency of 1-5 mm in diameter, and haven't taken antibiotics in the past three months.
What does the study involve?
The study involves treating 60 single-rooted teeth in patients and 60 freshly extracted single-rooted teeth in a lab. The teeth are divided into six groups, each using different cleaning methods with or without the XP-endo Finisher.
What are the possible benefits and risks of participating?
The main benefit is improved dental health and appearance. The risks are minimal and almost non-existent.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
March 2021 to March 2025.
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Farah Estefane, estefanfarah3@gmail.com
Contact information
Public, Scientific, Principal Investigator
Damascus University, Mazzah
Damascus
-
Syria
 ORCID ID |
0009-0007-6488-6735 |
|---|---|
| Phone | +963 988704477 |
| farah3.estefan@damascusuniversity.edu.sy |
Public, Scientific, Principal Investigator
Damascus University, Mazzah
Damascus
-
Syria
| Phone | +963 988704477 |
|---|---|
| estefanfarah3@gmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A comparative study of several final irrigation protocols and the use of XP-endo finisher in changing of the microbial root canal flora |
| Study objectives | H₁: There is no significant difference in bacterial count and antibacterial efficacy against Enterococcus faecalis after root canal irrigation using sodium hypochlorite (NaOCl) without XP-endo Finisher compared to irrigation using sodium hypochlorite with XP-endo Finisher. H₂: There is no significant difference in bacterial count and antibacterial efficacy against Enterococcus faecalis after root canal irrigation using sodium hypochlorite (NaOCl) with XP-endo Finisher compared to irrigation using sodium hypochlorite without XP-endo Finisher. H₃: There is no significant difference in bacterial count and antibacterial efficacy against Enterococcus faecalis after root canal irrigation using sodium hypochlorite (NaOCl) combined with QMiX without XP-endo Finisher compared to irrigation using sodium hypochlorite with QMiX with XP-endo Finisher. H₄: There is no significant difference in bacterial count and antibacterial efficacy against Enterococcus faecalis after root canal irrigation using sodium hypochlorite (NaOCl) combined with QMiX with XP-endo Finisher compared to irrigation using sodium hypochlorite with QMiX without XP-endo Finisher. H₅: There is no significant difference in bacterial count and antibacterial efficacy against Enterococcus faecalis after root canal irrigation using sodium hypochlorite (NaOCl) combined with chlorhexidine (CHX) without XP-endo Finisher compared to irrigation using sodium hypochlorite with chlorhexidine with XP-endo Finisher. H₆: There is no significant difference in bacterial count and antibacterial efficacy against Enterococcus faecalis after root canal irrigation using sodium hypochlorite (NaOCl) combined with chlorhexidine (CHX) with XP-endo Finisher compared to irrigation using sodium hypochlorite with chlorhexidine without XP-endo Finisher. |
| Ethics approval(s) |
Approved 21/02/2022, The Biomedical Research Ethics Committee (BMREC) of Damascus University (Damascus University, Damascus, -, Syria; +963 1133923482; ap.srd@damascusuniversity.edu.sy), ref: DN-210224-185 |
| Health condition(s) or problem(s) studied | Patients with necrotic pulp |
| Intervention | Root canal treatment. The study samples (both clinical and laboratory) were divided into six groups: Groups 1 and 2: Irrigation was performed using 5.25% sodium hypochlorite with and without the XP-endo Finisher, respectively. Groups 3 and 4: Irrigation was performed using 5.25% sodium hypochlorite with 2% chlorhexidine, with and without the XP-endo Finisher, respectively. Groups 5 and 6: Irrigation was performed using 5.25% sodium hypochlorite with QMIX, with and without the XP-endo Finisher, respectively. The randomization process was performed using sealed opaque envelopes managed by an independent party. |
| Intervention type | Other |
| Primary outcome measure | To compare the bacterial count before and after clinical root canal preparation using three final irrigation protocols: 1. Sodium hypochlorite (NaOCl) alone 2. Sodium hypochlorite combined with chlorhexidine (CHX) 3. Sodium hypochlorite combined with QMiX |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 14/03/2021 |
| Completion date | 14/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 6 groups (10 teeth in each group) |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Patients medically free from any systemic diseases 2. Patients between the age group of 20 and 40 years old 3. Absence of preoperative pain 4. Necrotic cases only 5. Presence of periapical radiolucency 1-5 mm in diameter 6. No antibiotics in the past three months |
| Key exclusion criteria | 1. Teeth with symptomatic irreversible pulpitis 2. Teeth with open apices 3. Consumption of any type of antibiotics in the past three months 4. Systemic diseases 5. Pregnant and lactating females |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 01/01/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Albaramka
Damascus
-
Syria
| Phone | +963(0)1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon request from Prof. Dr Kinda Layous (kinda.layous@damascusuniversity.edu.sy). All of the patients' data will be available upon request. Consent was obtained from the participants. |
Editorial Notes
28/04/2025: Study's existence confirmed by the Biomedical Research Ethics Committee (BMREC) of Damascus University.
