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

S

Sinai University

Status

Completed

Conditions

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

Treatments

Radiation: low-level laser therapy (LLLT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05279911
FWA00025577

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

Control
No Intervention group
Description:
Implants were randomly inserted in 20 non-lased T2DM patients (Control)
Low level laser therapy
Experimental group
Description:
Implant were randomly inserted in 20 lased T2DM patients (Intervention)
Treatment:
Radiation: low-level laser therapy (LLLT)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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