Testing of iodine solution to fight bacteria in unsuccessfully treated root canals
| ISRCTN | ISRCTN34453184 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34453184 |
| Secondary identifying numbers | SR23001648 |
- Submission date
- 12/04/2024
- Registration date
- 18/04/2024
- Last edited
- 18/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Oral inflammatory diseases encompass a wide range of conditions, particularly apical periodontitis. This type of infection is caused by bacterial biofilm communities adhering to canal walls. Effective management through root canal therapy focuses on eradicating existing infections and preventing bacterial re-infection of the pulp space and surrounding tissues. Success in treatment relies heavily on understanding the microbiological characteristics of apical periodontitis and implementing thorough cleaning, shaping, and irrigation techniques to reduce bacterial load within the root canal system.
The study aims to enhance our understanding of the importance of chemomechanical preparation in endodontic treatment specifically the final irrigation phase. Consequently, maximize the treatment outcomes quality, oral health and patient satisfaction.
Who can participate?
This investigation included patients aged between 18 and 65 years who were referred to the Endodontic Department during the study period because of the presence of apical lesions. The patients also should have signs of asymptomatic periapical periodontitis such as minor percussion pain, or large untreated caries or fractures of the root/crown on one or more maxillary or mandibular anterior (central, lateral and premolar). These patients were radiographed to ensure the existence of periapical lesions <5*5mm.
What does the study involve?
The applied treatments included first Sodium hypochlorite (NaOCl) then the Iodine-Potassium Iodide (IKI) Solution. Two concentrations of IKI were used: 2% and 5%. In the control group, only Sodium hypochlorite (No IKI Solution) was applied.
All samples underwent immediate processing in a specialized laboratory within one hour of collection. The samples were plated onto nutrient agar plates and incubated for 48h at 37°C in aerobic conditions, followed by counting colonies. Monitor of the healing of apical periodontitis radiographically for 12 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The research was performed in the Endodontic Department at Damascus University, Syria
When is the study starting and how long is it expected to run for?
January 2022 to August 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Meerna SARKEES
mirna2.sarkis@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal Investigator
Mahata street
Homs
-
Syria
 ORCID ID |
0000-0001-6290-5057 |
|---|---|
| Phone | +963 955103481 |
| mirna2.sarkis@damascusuniversity.edu.sy |
Study information
| Study design | Single-centre interventional double-blinded randomized parallel clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Dental clinic |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Evaluation of the efficacy of iodine potassium iodide IKI irrigating solution in endodontic treatment (in-vivo bacteriologic and radiographic study) |
| Study objectives | Iodine potassium iodide has an antibacterial effect makes it suitable as a final irrigation solution in the single-visit treatment of teeth with periapical lesions |
| Ethics approval(s) |
Approved 29/01/2022, The Biomedical Research Ethics Committee (BMREC) of Damascus University (Damascus University, Mazzeh Highway, Damascus, -, Syria; +963 1133923192; sdg@damascusuniversity.edu.sy), ref: DN-290122-18 |
| Health condition(s) or problem(s) studied | Single-rooted teeth with periapical lesions |
| Intervention | The applied treatments included first Sodium hypochlorite (NaOCl) then the Iodine-Potassium Iodide (IKI) Solution. Two concentrations of IKI were used: 2% and 5%. In the control group, only Sodium hypochlorite (No IKI Solution) was applied. Teeth were allocated, using the simple randomization method, into three groups at a ratio of 1:1:1 depending on the IKI utilized concentration. Patients were asked to randomly select an envelope from a batch of 15 opaque, sealed envelopes per study group, each containing cards with varying final irrigation solutions. |
| Intervention type | Other |
| Primary outcome measure | Bacterial count was determined by culturing the samples on nutrient agar plates for 48h at 37°C in aerobic conditions, followed by counting colonies. |
| Secondary outcome measures | Monitor the healing of apical periodontitis radiographically for 12 months |
| Overall study start date | 29/01/2022 |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. Age between 18 and 65 years 2. Patients were referred to the Endodontic Department with the presence of apical lesions. 3. The patients with signs of asymptomatic periapical periodontitis such as minor percussion pain, or large untreated caries or fractures of the root/crown on one or more maxillary or mandibular anterior (central, lateral and premolar). 4. Periapical lesions <5*5mm which were verifier radiographed. |
| Key exclusion criteria | 1. Presence of systemic diseases that compromised general immune status 2. Pregnant females 3. Patients with preoperative anxiety 4. Patients who received antibiotic therapy within the past 3 months 5. Open-apex teeth 6. Teeth with multicanals, 7. Internal or external resorptions 8. Patients with advanced periodontitis (more than 5mm periodontal attachment and bone loss) 9. Teeth that were unsuitable for single-visit treatment, containing moist canals with exudation or pus. |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 03/08/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Fayez Mansour Street
Damascus
-
Syria
Sponsor information
University/education
Fayez Mansour Street
Damascus
-
Syria
| Phone | +963 1133923192 |
|---|---|
| sdg@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from (mirna2.sarkis@damascusuniversity.edu.sy) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 18/04/2024 | No | No |
Additional files
Editorial Notes
18/04/2024: Trial's existence confirmed by Damascus University.
