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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Mhd Obada Shakkour
Public, Scientific, Principal Investigator

Mezzeh Highway
Damascus
0000
Syria

ORCID ID	0009-0004-9692-2276
Phone	+963 999041252
Email	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

Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University

Mezzeh Highway
Damascus
4671
Syria

Sponsor information

Damascus University
University/education

Mezzeh Highway
Damascus
4671
Syria

Phone	+963 944812030
Email	vice.research@damascusuniversity.edu.sy
Website	http://www.damascusuniversity.edu.sy
"ROR"	https://ror.org/03m098d13

Funders

Funder type

Other

Investigator initiated and funded

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.