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

March 5, 2022 updated by: Mohamed Moawed Ibrahim Ghoneim, PhD, Sinai University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Implants were randomly inserted in 20 non-lased T2DM patients (Control)
Experimental: Low level laser therapy
Implant were randomly inserted in 20 lased T2DM patients (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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density
Time Frame: Week 1
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
Bone density
Time Frame: Month 1
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
Bone density
Time Frame: Month 3
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
Bone density
Time Frame: 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.
Month 4
Osteoprotegrin (OPG) level
Time Frame: Week 1
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
Osteoprotegrin (OPG) level
Time Frame: Month 1
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
Osteoprotegrin (OPG) level
Time Frame: Month 3
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
Osteoprotegrin (OPG) level
Time Frame: 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.
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinai University

Collaborators

Al-Azhar University
Misr International University
Delta University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

January 22, 2022

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 5, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 5, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA00025577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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