Clinical trial NCT05279911: Effect of Low-level Laser Therapy on Type II Controlled Diabetic Patients After Dental Implant Insertion
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: T2DM (Type 2 Diabetes Mellitus)
Low-level Laser Therapy
Bone Density Increased
Keywords: T2DM (Type 2 Diabetes Mellitus)
Dental Implant insertion
Osteoprotegrin (OPG)
Bone Density
Low-level laser therapy
LLLT
Lead sponsor: Sinai University
Sponsor class: OTHER
Collaborators: name: Misr International University
name: Al-Azhar University
name: Delta University for Science and Technology
First posted: 2022-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Study design: A randomized case control study. A total of 40 adult participants of both genders of at least 21 years old were included in the study. All participants were controlled T2DM patients for more than 2 years (diagnosed according to the American Diabetes Association criteria) \[21\]. Patients were able and willing to participate in the study. Patients were recruited from out-patient clinic of Oral Diagnosis at Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone density
timeFrame: Week 1
measure: Bone density
timeFrame: Month 1
measure: Bone density
timeFrame: Month 3
measure: Bone density
timeFrame: Month 4
measure: Osteoprotegrin (OPG) level
timeFrame: Week 1
measure: Osteoprotegrin (OPG) level
timeFrame: Month 1
measure: Osteoprotegrin (OPG) level
timeFrame: Month 3
measure: Osteoprotegrin (OPG) level
timeFrame: Month 4
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine for Girls, Al-Azhar University
city: Cairo
country: Egypt
facility: Misr International University
city: Cairo
country: Egypt
facility: Misr University for Science and Technology (MUST)
city: El-Arish
country: Egypt
facility: Sinai University
city: Gamasa
country: Egypt
facility: Delta University of Science and Technology
Study officials:
References: