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

Not Applicable

Completed

• Conditions: Low-level Laser Therapy; T2DM (Type 2 Diabetes Mellitus); Bone Density Increased
• Interventions: Radiation: low-level laser therapy (LLLT)

• Registration Number: NCT05279911
• Lead Sponsor: Sinai University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-03
• Primary Completion: 2022-01-05
• Study Completion: 2022-01-22
• Study First Submitted: 2022-02-24
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-05
• Last Update Submitted: 2022-03-05
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low level laser therapy	low-level laser therapy (LLLT)	Implant were randomly inserted in 20 lased T2DM patients (Intervention)

Primary Outcome Measures

Name	Time	Method
Bone density	Month 4	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.
Osteoprotegrin (OPG) level	Month 4	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.

Trial Locations

Locations (5)

Faculty of Dental Medicine for Girls, Al-Azhar University; 🇪🇬 Cairo, Egypt

Misr University for Science and Technology (MUST); 🇪🇬 Cairo, Egypt

Delta University of Science and Technology; 🇪🇬 Gamasa, Egypt

Misr International University; 🇪🇬 Cairo, Egypt

Sinai University; 🇪🇬 El-Arish, Egypt