The effect of a laser on large-sized apical lesion healing
| ISRCTN | ISRCTN99457940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99457940 |
- Submission date
- 14/11/2022
- Registration date
- 17/11/2022
- Last edited
- 17/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Apical lesions are holes that appear in the bone surrounding portals of exit from infected tooth root canal systems. Healing of large apical lesions is a long-term process. Many studies show that bio-stimulation with a diode laser may accelerate bone regeneration, so this study will evaluate the effect of diode laser bio-stimulation on the healing of large-sized apical lesions.
Who can participate?
Patients aged between 25 and 44 years old with at least one upper incisor with an apical lesion
What does the study involve?
Activated irrigation is a method to agitate and improve the flow of irrigants to the root canal system, which wash out debris and lubricate the canal. Patients will be divided into two groups. Group 1 (the control group) will be divided into three sub-groups where irrigant activation is carried out either ultrasonically, with the Xp-Endo finisher or with a diode laser. Group 2 (the study group) will be divided into three groups as the control group but with bio-stimulation by external application of a diode laser. Patients of all groups will be recalled for clinical follow-up at 1, 3, 7, and 14 days to assess pain, swelling and tooth mobility. Patients of all groups will be recalled for x-ray follow-up at 6 and 12 months, when the apical lesions will be assessed.
What are the possible benefits and risks of participating?
The expected benefits of participating are getting rid of apical lesions, accelerating the healing process and decreasing postoperative pain. There are no expected risks of participating because root canal treatment is considered a safe treatment.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
May 2022 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mohammad Tamer Abbara, tamerabbara@gmail.com
Contact information
Scientific
Al-Mazzeh St
PO Box 3062
Damascus
20872
Syria
 ORCID ID |
0000-0003-3664-0248 |
|---|---|
| Phone | +963 (0)932759240 |
| tamer92.abbara@damascusuniversity.edu.sy |
Study information
| Study design | 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 | https://drive.google.com/file/d/1xZL8OOcvoqsAsztO7ghSvKAdZHTqxLpm/view?usp=drivesdk |
| Scientific title | Effect of low-level laser application on the acceleration of apical lesion healing in single-rooted teeth after using different irrigation activation protocols |
| Study objectives | H0: There are no significant differences between groups in apical lesion healing and postoperative pain. H1: There are significant differences between groups in apical lesion healing and postoperative pain. |
| Ethics approval(s) | Approved 18/05/2020, the Institutional Review Board (IRB) of Damascus University (Al-Mazzeh St., Damascus, PO Box 3062, Syria; +963 (0)1144923000; president@damascusuniversity.edu.sy), ref: 1734 |
| Health condition(s) or problem(s) studied | Apical lesions of permanent upper incisors |
| Intervention | Following the randomization procedure, patients will be divided into two groups (45 permanent upper incisors in each group) using the simple randomization method and a random sequence created using the website https://www.random.org/: Group 1 (control group) will be divided into three sub-groups: G1-A: Irrigant activation with Ultrasonic G1-B: Irrigant activation with Xp-Endo finisher G1-C: Irrigant activation with Diode laser Group 2 (study group) will be divided into three groups as the control group but with bio-stimulation by external application of diode laser. After working length determination, instrumentation and sterilizing root canals, sodium hypochlorite (SH) and EDTA will be activated in three ways: Ultrasonic activation groups: U-file will be inserted 2 mm before the apex, where SH will be activated for 5 minutes and EDTA will be activated for 30 seconds. Xp-Endo Finisher groups: Xp-Endo Finisher file will be inserted to the full working length, where SH will be activated for 5 minutes and EDTA will be activated for 30 seconds. Diode laser groups: the tip of the diode laser device will be inserted 2 mm before the apex, where SH will be activated for 5 minutes and EDTA will be activated for 30 seconds. All groups will be irrigated with chlorhexidine as the final irrigant, obturated with Gutta-percha and Ah-plus sealer using continuous vertical waves technique, and restored with resin-bonded restoration. As for bio-stimulation groups, mucosa opposing the peri-apical area will be irradiated with a diode laser tip for 60 seconds immediately and 2, 4, 6, 8, 10, and 12 days after finishing the treatment. Patients of all groups will be recalled for clinical follow-up at 1, 3, 7, and 14 days by assessing postoperative pain, swelling and tooth mobility in all groups. Patients of all groups will be recalled for radiographical follow-up at 6 and 12 months, where the volume and density of apical lesions will be determined using CBCT images and scored in all groups. Finally, data will be statistically analyzed using SPSS. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | 1. Postoperative pain measured using the visual analog scale (VAS) before treatment, 1, 3, 7 and 14 days 2. Swelling and tooth mobility measured according to their presence/absence before treatment, 1, 3, 7 and 14 days 3. Apical lesion volume and density measured using CBCT images before treatment, 6, and 12 months |
| Secondary outcome measures | Percentage of apical lesions healing measured using CBCT images by comparing the baseline with 6, and 12 months follow-up images |
| Overall study start date | 18/05/2020 |
| Completion date | 01/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 44 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | 1. Healthy patients without any systemic disease or compromised immune status 2. Patients aged between 25 and 44 years old 3. Patients with at least one permanent closed-apex upper incisor first with an asymptomatic apical lesion sized 5 to 10 mm² |
| Key exclusion criteria | 1. Patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss) 2. Untreatable teeth (root fracture, unrestorable tooth, massive internal or external resorption) 3. Smokers |
| Date of first enrolment | 20/11/2022 |
| Date of final enrolment | 20/11/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
PO Box 3062
Damascus
20872
Syria
Sponsor information
University/education
Al-Mazzeh St
PO Box 3062
Damascus
20872
Syria
| Phone | +963 (0)114452627 |
|---|---|
| dl.srd@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | The effect of the irrigant activation protocol on postoperative pain | 03/10/2023 | 03/10/2023 | Yes | No |
| Results article | The effect of diode laser on postoperative pain | 14/03/2024 | 17/06/2025 | Yes | No |
Editorial Notes
17/06/2025: Publication reference added.
05/10/2023: Internal review.
03/10/2023: Publication reference added.
14/02/2023: The study setting has been changed from ‘Other’.
17/11/2022: Trial's existence confirmed by Damascus University.
