Root canal treatment outcomes using different ways to clean and disinfect teeth, including light technology (LASER)
| ISRCTN | ISRCTN91211125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91211125 |
| Secondary identifying numbers | DENT10202302 |
- Submission date
- 26/03/2025
- Registration date
- 08/04/2025
- Last edited
- 02/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This clinical study aims to understand if the effectiveness of root canal treatment, a common dental procedure to save infected teeth, can be enhanced. The goal is to compare different methods of existing root canal disinfection protocols, with the aim of improving the overall success of the treatment.
Who can participate?
All adult patients who are able to provide consent to have root canal treatment of their tooth with root canal infection.
What does the study involve?
For participants, this study involves undergoing root canal treatment as required for their dental condition. The crucial aspect of the study is the comparison of different techniques used to clean and disinfect the inside of the tooth's root canals during this treatment.
Root canal treatment as already planned and consented for.
The treatment will be the standard of care except for one specific part: the way the disinfectant (irrigant) is activated within the root canals at the end of the cleaning process.
Patients will be randomly allocated to one of three groups, each receiving a different method of irrigant activation:
-Manual agitation
-Sonic activation
-LASER activation
This irrigant activation step will typically last for 1 to 2 minutes per root canal.
Patients will need to attend five visits in total:
1. Initial assessment and consent
2. Treatment
3. 2-week review
4. 1-year review
5. 2-year review
Anonymised information about the patients’ root canal treatment and anonymised radiographs will be sent to researchers at the University of Central Lancashire for analysis. No identifiable data will be sent outside of the patients' dental practice
Participation is entirely voluntary, and patients can withdraw at any time without giving a reason and without it affecting the standard of care they receive
What are the possible benefits and risks of participating?
There are no additional risks involved in taking part in the study beyond those associated with standard root canal treatment.
There is no direct benefit for participating, but the study aims to improve the understanding and future success of root canal treatments for other patients.
At the end of the treatment and at each review, patients will be informed of any problems encountered and the outcome of your treatment. If the root canal treatment is deemed to have failed, the research team will provide the same treatment as the standard of care (root canal re-treatment, extraction, or endodontic microsurgery).
Where is the study run from?
University of Central Lancashire (UK)
When is the study starting and how long is it expected to run for?
January 2023 to December 2027
Who is funding the study?
DentsplySirona has loaned investigators sonic activator (Endoactivator).
Who is the main contact?
Professor Shanon Patel, shanon.patel1@gstt.nhs.uk
Contact information
Scientific, Principal Investigator
Dawood & Tanner
45 Wimpole St
London
W1G 8SB
United Kingdom
 ORCID ID |
0000-0003-0614-6951 |
|---|---|
| Phone | +44 20 7935 0080 |
| shanon.patel1@gstt.nhs.uk |
Public
13 Regent Street
Preston
PR1 3 LX
United Kingdom
| ORCID ID |
0000-0001-6274-5188 |
|---|---|
| Phone | +44 7398276670 |
| skanagasingam1@uclan.ac.uk |
Public
Gower St
London
WC1E 6AE
United Kingdom
| ORCID ID |
0000-0002-4660-5369 |
|---|---|
| t.pimentel@ucl.ac.uk |
Study information
| Study design | Interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Dental clinic |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Outcome of non-surgical endodontic treatment using different irrigant activation techniques |
| Study acronym | TuLe |
| Study objectives | There is no difference in outcome of non-surgical endodontic treatment using different irrigant activation techniques (GP pumping, Sonic activation and Laser activation) |
| Ethics approval(s) |
Approved 04/01/2023, SoMD Ethics Review Panel (University of Central Lancashire, Preston, PR1 2HE, United Kingdom; -; some@uclan.ac.uk), ref: DENT10202302 |
| Health condition(s) or problem(s) studied | Healing of apical periodontitis (due to primary endodontic infection) |
| Intervention | Patients with root canal disease (also known as pathology of endodontic origin) who meet the inclusion criteria and not the exclusion criteria will be randomly allocated to one of three groups. The endodontic treatment for all groups will follow the standard of care in all stages, except for the method of activation of the irrigant. The irrigant activation will typically last 1 to 2 minutes per root canal at the end of the mechanical preparation. The three study arms are: - Manual agitation: This group will receive the standard method of irrigant activation, involving hand agitation or gutta-percha pumping. - Sonic activation: In this group, a sonic device will be used to activate the irrigant within the root canals. - LASER activation: This group will have their irrigant activated using laser light with Waterlase Total Duration of Treatment and Follow-up: The study is expected to span over a period of 3 years. Participants will attend 5 visits as part of the study. 1. Initial assessment and consent: This visit determines eligibility and provides study information. 2. Treatment: The assigned irrigant activation technique will be performed during the root canal treatment. 3. 2-weeks review: This appointment/phone review assesses the initial response and any immediate effects (post-op pain). 4. 1-year review: A follow-up appointment to evaluate the medium-term results of the treatment. Clinical and radiographic review using periapical radiographs and CBCT 5. 2-year review: The final follow-up to determine the sustained success of the different treatment methods. Clinical and radiographic review using periapical radiographs and CBCT Clinical and radiographic assessments will be conducted at baseline (initial assessment), 12 months, and 24 months post-operatively. Details of the Randomisation Process: Patients will be randomly allocated to one of the three study groups (Manual agitation, Sonic activation, LASER activation) after being assessed clinically and radiographically using an online tool (random.org) |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sonic activation (Endoactivator, DentsplySirona,, Charlotte, North Carolina, USA ) and laser activation using Waterlase (BIOLASE, Megagen,Seoul, Korea). |
| Primary outcome measure | Healing outcome after non-surgical treatment measured using clinical examination (intact restoration, no fistulas or swelling, no mobility of the teeth or tenderness to percussion) and radiographical assessment using periapical radiographs and CBCT (absence or reduction of any radiolucencies or widening of the periodontal ligament space and vertical or horizontal fractures and absence of external root resorption) at 12 months and 24 months |
| Secondary outcome measures | 1. Patient self-reported pain measured using VAS (Visual Analogue Scale) pre-operatively, and then day 1, 3, 5, 7 and 14 following the treatment 2. Patients' quality of life measured using OHIP-14 preoperatively and at year 1 and year 2 |
| Overall study start date | 04/01/2023 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 264 |
| Key inclusion criteria | 1. Patients either male or female over the age of 18 (who can consent for themselves) in good general health 2. Patients with clinical symptoms of pathology of endodontic origin who need endodontic treatment 3. All anterior and posterior teeth included in study |
| Key exclusion criteria | 1. External or internal root resorption 2. Pregnant women, in view of requirements for radiographs. 3. Patients younger than 18 years. 4. Patients unable to give consent. 5. Patients who have been administered antibiotics in the previous month. 6. Immunocompromised patients. |
| Date of first enrolment | 10/01/2023 |
| Date of final enrolment | 31/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Preston
PR1 2HE
United Kingdom
London
W1G 8SB
United Kingdom
Colchester
CO4 9YQ
United Kingdom
Sponsor information
University/education
Fox Street
Preston
PR1 2HE
England
United Kingdom
| aali46@uclan.ac.uk | |
| Website | https://www.uclan.ac.uk |
"ROR" |
https://ror.org/010jbqd54 |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 10/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
02/05/2025: Contact details updated.
27/03/2025: Trial's existence confirmed by University of Central Lancashire.
