The affect of diode laser on healing after dental extraction in patients diabetes mellitus
| ISRCTN | ISRCTN57090615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57090615 |
- Submission date
- 14/02/2025
- Registration date
- 20/02/2025
- Last edited
- 20/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Patients visiting dental clinics and those suffering from type 2 diabetes often experience vascular fragility, subsequent bleeding, delayed healing, and the need for various diluents. Therefore, it is essential to develop special materials for these patients that reduce bleeding, accelerate healing, and minimize infections, making extraction safe, easy, and comfortable for both the doctor and the patient. One of these materials is a diode laser, which has numerous positive effects on the body, including pain relief, reduced bleeding, and the promotion of growth factors, thereby enhancing healing.
Who can participate?
Patients aged 35 years and older with Type II Diabetes require symmetrical tooth extraction.
What does the study involve?
The control group will receive a placebo laser after the tooth while the experimental group will receive a diode laser after tooth extraction. The participants will be followed up for 7 days.
What are the possible benefits and risks of participating?
The potential benefits of using lasers for diabetics include pain relief, bleeding, and expedited healing. However, the potential risks involve prolonged working time and Contraindications in cases of local infection.
Where is the study run from?
Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University (Syria)
When is the study starting and how long is it expected to run for?
November 2022 to January 2025
Who is the funding of the study?
Investigator initiated and funded
Who is the main contact?
Dr Mhd Obada Shakkour, oshakkour95@gmail.com
Contact information
Public, Scientific, Principal Investigator
Mezzeh Highway
Damascus
0000
Syria
 ORCID ID |
0009-0004-9692-2276 |
|---|---|
| Phone | +963 999041252 |
| obada95.shakkour@damascusuniversity.edu.sy |
Study information
| Study design | Double-blind randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | The affect of diode laser on healing after dental extraction in patients type 2 diabetes mellitus |
| Study objectives | The null hypothesis posited that there is a significant difference between a diode laser and a placebo laser in enhancing healing after tooth extractions in individuals with type 2 diabetes mellitus. |
| Ethics approval(s) |
Approved 26/11/2024, Damascus University (Oral and Maxillofacial Surgery Department - Faculty of Dental Medicine) (Mezzeh Highway, Damascus, -, Syria; +963 1133923192; ap.srd@damascusuniversity.edu.sy), ref: DN-261124-351 |
| Health condition(s) or problem(s) studied | Improving healing after dental extraction in individuals with diabetes |
| Intervention | This study is a randomized controlled trial, involving the application of a diode laser and a placebo laser. The control group will receive a placebo laser after the tooth while the experimental group will receive a diode laser after tooth extraction. The diode and placebo lasers will be randomized into two groups using http://www.randomizer.org/. The follow-up period for each patient is one week, with visits: 1) 2 days postoperative and 2) 7 days postoperative. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Wound healing will be measured at three endpoints: T0 immediately after laser application, T1 at 2 days, and T2 at 7 days by Landry Gingival healing index |
| Secondary outcome measures | Pain will be assessed using a visual analog scale and the painkiller pills at T0 immediately after laser application, T1 at 2 days, and T2 at 7 days |
| Overall study start date | 01/11/2022 |
| Completion date | 15/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Patients with Type 2 diabetes and HbA1c levels between 8-10%. 2. Individuals over 35 years of age. 3. Patients classified as ASA type II – III. |
| Key exclusion criteria | 1. HbA1c less than 8 or greater than 10. 2. Antibiotic or NSAID use1- days before extraction. 3. Smoking more than 10 cigarettes a day. 4. Local infection at the site of the tooth to be extracted. |
| Date of first enrolment | 12/01/2024 |
| Date of final enrolment | 05/01/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
4671
Syria
Sponsor information
University/education
Mezzeh Highway
Damascus
4671
Syria
| Phone | +963 944812030 |
|---|---|
| vice.research@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 | |
|---|---|
| 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 |
Editorial Notes
20/02/2025: Trial's existence confirmed by Damascus University.
