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
Verified date | March 2022 |
Source | Sinai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Sinai University | Al-Azhar University, Delta University for Science and Technology, Misr International University |
Egypt,
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 |
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