Using olive oil in the removal of broken tools from the root canal
| ISRCTN | ISRCTN28549373 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28549373 |
| Secondary identifying numbers | ID # 417, dated 16/11/2020 |
- Submission date
- 03/11/2022
- Registration date
- 04/11/2022
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Root canal treatment is a dental procedure used to treat infection at the centre of a tooth. Broken instruments within the root canal during root canal treatment are an unwanted and frustrating complication. This study aims to evaluate the effectiveness of using olive oil as a lubricant while removing broken instruments from root canals and the time required compared with using ethylenediaminetetraacetic acid (EDTA) as a lubricant.
Who can participate?
Patients aged between 21 and 54 years with broken instruments in the root canal of the molar tooth.
What does the study involve?
Participants are randomly allocated to one of two groups. The study involves removing the broken instruments using olive oil as the lubricant during the procedure for the study group, and EDTA as the lubricant for the control group.
What are the possible benefits and risks of participating?
The benefits are the removal of the SI and filling of the root canal. There are no risks as in the worst cases the tool will not be removed, which will lead to different treatment options.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
November 2020 to November 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Ahmad Alaloul, ahmad.alaloul@damascusuniversity.edu.sy
Contact information
Principal Investigator
Almazzah St - 1602
Damascus
00000
Syria
 ORCID ID |
0000-0002-9714-2501 |
|---|---|
| Phone | +963 (0)991333311 |
| ahmad.alaloul@damascusuniversity.edu.sy |
Study information
| Study design | Two-arm randomized parallel superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Comparison between EDTA and olive oil as lubricant agents in intracanal separated instruments removal for lower molars: in vivo study |
| Study hypothesis | Null hypothesis: olive oil is not effective compared to ethylenediaminetetraacetic acid (EDTA) as a lubricant agent in endodontic treatment Alternative hypothesis: olive oil is effective compared to EDTA as a lubricant agent in endodontic treatment |
| Ethics approval(s) | Approved 16/11/2020, the Institutional Review Board (IRB) at Damascus University (postal address: not available; +963 (0)1133923482; srd@damasuniv.edu.sy), ref: 417 |
| Condition | Separated instrument (SI) in the middle third of the mesio-lingual canal of mandibular first molars |
| Intervention | Current interventions as of 14/11/2022: Participants are randomized with a 1:1 allocation ratio (simple randomizations using Excel sheets) to use either EDTA (15 molars) or olive oil (15 molars) as the lubricant agent used in SI removal in curved canals. An additional 30 teeth are used as a control to test the effectiveness of EDTA and olive oil in straight canals and they were divided into 2 groups as well (15 teeth olive oil, 15 teeth EDTA). A cone beam computed tomography (CBCT) image is taken to study the case. Under local anaesthesia and rubber dam isolation, all caries and previous restorations are removed. The access cavity is refined using an Endo-Z bur. The working length in canals without SI is determined with an apex locator. Mesio-buccal and distal orifice canals are closed using cotton balls. Terauchi’s technique is followed in SI retrieval. A micro-trephine bur is used to expose the coronal third of the instrument. After filling the canal with the lubricant agent until the middle of the pulp chamber, the ultrasonic tip is activated at the medium power settings by push and pull movement in the cavity as far away as possible from the SI until it is removed. _____ Previous interventions: Participants are randomized with a 1:1 allocation ratio (simple randomizations using Excel sheets) to use either EDTA (15 molars) or olive oil (15 molars) as the lubricant agent used in SI removal. A cone beam computed tomography (CBCT) image is taken to study the case. Under local anaesthesia and rubber dam isolation, all caries and previous restorations are removed. The access cavity is refined using an Endo-Z bur. The working length in canals without SI is determined with an apex locator. Mesio-buccal and distal orifice canals are closed using cotton balls. Terauchi’s technique is followed in SI retrieval. A micro-trephine bur is used to expose the coronal third of the instrument. After filling the canal with the lubricant agent until the middle of the pulp chamber, the ultrasonic tip is activated at the medium power settings by push and pull movement in the cavity as far away as possible from the SI until it is removed. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Successful removal of SI (0= not successful, 1= successful), measured at the time of treatment, the same day as the operation |
| Secondary outcome measures | Time until the removal of the SI measured in minutes at the time of the operation |
| Overall study start date | 16/11/2020 |
| Overall study end date | 01/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 (30 for the curved canals, and 30 for control in straight canals) |
| Participant inclusion criteria | 1. Patients aged between 21 and 54 years 2. SI in the middle third of the mesio-lingual canal of mandibular first molars 3. Attend the endodontic department during the study period 4. Agreed to participate in the study |
| Participant exclusion criteria | 1. Systemic diseases that compromise general immune status 2. Unrestorable teeth 3. Curved mesio-lingual canal (>30 degrees) 4. Long mesio-lingual canal (>25 mm) 5. >5 mm SI length |
| Recruitment start date | 01/05/2021 |
| Recruitment end date | 01/05/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Department of Endodontics
Almazzah St
Damascus
00000
Syria
Sponsor information
University/education
Almazzah St
Damascus
00000
Syria
| Phone | +963 (0)11 33923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.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 | 15/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The authors are preparing the first manuscript for publication and will publish it in a Q1 journal as soon as the manuscript is ready |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the main author Dr Ahmad Alaloul (ahmad.alaloul@damascusuniversity.edu.sy) |
Editorial Notes
14/11/2022: The following changes were made to the trial record:
1. The interventions were changed.
2. The target number of participants was changed from 30 to 60.
04/11/2022: Trial's existence confirmed by the Institutional Review Board (IRB) at Damascus University.
