Evaluation of the effect of a low-level laser in the surgical treatment of periodontal pockets
| ISRCTN | ISRCTN13012199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13012199 |
- Submission date
- 22/06/2021
- Registration date
- 26/07/2021
- Last edited
- 26/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontal pockets are spaces surrounding the teeth under the gum line and are a symptom of periodontitis (gum disease). This study aims to evaluate the effect of a low-level laser in the surgical treatment of periodontal pockets.
Who can participate?
Healthy non-smoking adults between 35-50 years old with periodontal pockets
What does the study involve?
Participants' periodontal pockets are treated with either surgery (open flap debridment) or surgery and a low-level laser for 3 days (first, third and seventh days). Periodontal pockets, pain and dental hypersensitivity are measured before and after surgery
What are the possible benefits and risks of participating?
Both treatments are safe and should not cause any additional risks.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
August 2020 to December 2021
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Ghena Alshakoush
ghinash84@gmail.com
Contact information
Scientific
Baramkeh
Amin Alrihany St.
Jasmine Building
Damascus
-
Syria
 ORCID ID |
0000-0002-6314-0807 |
|---|---|
| Phone | +963 (0)956999341 |
| ghinash84@gmail.com |
Study information
| Study design | Single-center interventional blinded comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of the effect of biostimulation of the low-level laser in addition to surgical treatment of periodontal pockets - open flap debridement: a clinical comparative study |
| Study acronym | LLL |
| Study objectives | Treating periodontal pockets with open flap debridement in addition to a low-level laser (LLL) is more effective than not using it. |
| Ethics approval(s) | Approved 16/09/2020, Damascus University Ethics Committee (Dental College, Damascus University, Mazzeh Highway, Damascus, Syria; +963 (0)1133923486; sr.srd@damasuniv.edu.sy), ref: not applicable |
| Health condition(s) or problem(s) studied | Periodontal pockets |
| Intervention | This is a split-mouth study. In the control group periodontal pockets are treated with open flap debridment (OFD). In the study group in addition to OFD periodontal pockets are treated with a low-level laser (808 nm) for 3 days (first, third and seventh days). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Low level laser |
| Primary outcome measure | 1. Periodontal pockets measured by UNC15 probe at baseline and after 1 month of the surgery 2. Pain measured using a visual analogue scale after 24 hours and 3 and 7 days 3. Dental hypersensitivity measured using air syringe after 7 days and 1 and 3 months after surgery |
| Secondary outcome measures | 1. Relative Attachment Level (RAL) measured using a periodontal probe at baseline and after 1 month 2. Severity of gingivitis measured using Gingival Index (GI) at baseline and after 1 month |
| Overall study start date | 01/08/2020 |
| Completion date | 30/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 patients (70 teeth) |
| Key inclusion criteria | 1. Age between 35-50 years old 2. Periodontal depth from 7 mm and more after scaling and root planing stage |
| Key exclusion criteria | 1. Patients with diabetes 2. Smokers 3. Pregnant women 4. Patients who have been taking antibiotics for more than 3 months before the surgery 5. Patients who have had surgery in less than 6 months from the beginning of the treatment |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 20/12/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Al-Mazzeh Highway
Damascus
-
Syria
| Phone | +963 (0)2142581 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/12/2022 |
|---|---|
| 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 analysed during the current study are/will be available upon request from Dr Ghena Alshakoush (ghinash84@gmail.com). |
Editorial Notes
19/07/2021: Trial's existence confirmed by Damascus University.
