Effect of Low-level Laser Therapy on Type II Controlled Diabetic Patients After Dental Implant Insertion

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

Influence of Low-level Laser Therapy on Radiographic and Biochemical Profiles in Type II Controlled Diabetic Patients After Dental Implant Insertion: A Randomized Case Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05279911
• Other study ID #: FWA00025577
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: January 22, 2022

Study information

• Verified date: March 2022
• Source: Sinai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed therefore to evaluate bone density (BD) and OPG levels in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients. 40 T2DM patients were included in this study. Implants were randomly inserted in 20 non-lased T2DM patients (Control) and 20 lased T2DM patients (Intervention). BD and OPG levels in the PICF were assessed in both groups at the follow up points.

Description:

Background and objectives: Use of low-level laser therapy (LLLT) with dental implants has been suggested to improve bone quality during osseointegration. However, there is a lack of evidence about its influence on dental implants in diabetic patients. Osteoprotegrin (OPG) levels was reported as a biomarker for bone turnover to distinguish implant prognosis. This study aimed therefore to evaluate bone density (BD) and OPG levels in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients. Methods: 40 T2DM patients were included in this study. Implants were randomly inserted in 20 non-lased T2DM patients (Control) and 20 lased T2DM patients (Intervention). BD and OPG levels in the PICF were assessed in both groups at the follow up points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 22, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• None of the participants had other major illnesses or severe diabetic complications.
• A detailed medical history of each subject was obtained according to the detailed questionnaire of the modified Cornell Medical Index [22].
• Diabetic control was measured by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 months.
• Participants with partial edentulous posterior mandibular region with bone density ranging between D2 and D3, also having adjacent tooth with healthy periodontium were selected.

Exclusion Criteria:

• Any uncontrolled systemic diseases that prevent surgery for dental implant placement; (b) Need for guided bone regeneration or sinus lift for implant placement, and (c) History of radiation therapy in head and neck.
• Pregnant women, smokers and patients with para-functional habits, psychological problems or in-cooperated patients were also excluded.

Related Conditions & MeSH terms

• Bone Density Increased
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Low-level Laser Therapy
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Radiation:
• low-level laser therapy (LLLT)
low-level laser therapy (LLLT) with dental implants has been suggested to improve bone quality during osseointegration. Low-level laser (Gallium Aluminum Arsenide Diode [Ga-Al-As]) (wavelength: 808 nm, average power density: 50 mW, circular spot diameter:0.71 cm, spot area: 0.4cm2) in continuous mode was applied in six points in contact with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before and immediately after suturing. The application points were divided into two points in the labial region where the implant would be placed (apical and cervical); two points in the lingual region (apical and cervical); and two points in the occlusal direction. After suturing the laser protocol was repeated in the same points following the same protocol, resulting in a total dose of 66 J for each application moment (before and after implant placement).

Locations

Country	Name	City	State
Egypt	Faculty of Dental Medicine for Girls, Al-Azhar University	Cairo
Egypt	Misr International University	Cairo
Egypt	Misr University for Science and Technology (MUST)	Cairo
Egypt	Sinai University	El-Arish
Egypt	Delta University of Science and Technology	Gamasa

Sponsors (4)

Lead Sponsor	Collaborator
Sinai University	Al-Azhar University, Delta University for Science and Technology, Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density	Bone density was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Week 1
Primary	Bone density	Bone density was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Month 1
Primary	Bone density	Bone density was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Month 3
Primary	Bone density	Bone density was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Month 4
Primary	Osteoprotegrin (OPG) level	Osteoprotegrin (OPG) level was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Week 1
Primary	Osteoprotegrin (OPG) level	Osteoprotegrin (OPG) level was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Month 1
Primary	Osteoprotegrin (OPG) level	Osteoprotegrin (OPG) level was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Month 3
Primary	Osteoprotegrin (OPG) level	Osteoprotegrin (OPG) level was evaluated in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients.	Month 4