Back to results

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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

low-level laser therapy (LLLT)

About this trial

This is an interventional supportive care trial for T2DM (Type 2 Diabetes Mellitus) focused on measuring T2DM (Type 2 Diabetes Mellitus), Dental Implant insertion, Osteoprotegrin (OPG), Bone Density, Low-level laser therapy, LLLT

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Faculty of Dental Medicine for Girls, Al-Azhar University
Misr International University
Misr University for Science and Technology (MUST)
Sinai University
Delta University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Low level laser therapy

Arm Description

Implants were randomly inserted in 20 non-lased T2DM patients (Control)

Implant were randomly inserted in 20 lased T2DM patients (Intervention)

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05279911

First Posted

February 24, 2022

Last Updated

March 5, 2022

Sponsor

Sinai University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05279911

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 3, 2021 (Actual)

Primary Completion Date

January 5, 2022 (Actual)

Study Completion Date

January 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sinai University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

Investigator

Masking Description

Patients were included in the study after fulfilling all the eligibility criteria and signing the informed consent form for participation and permission to use obtained data or research purposes. Patients were randomly allocated according to the type of treatment (control group: conventional implant placement and intervention group: LLLT) that were performed considering the implant as a unit. To ensure concealment of randomization, consecutively numbered envelopes were used. The team of surgeons only became aware of the type of intervention at the time of surgery, when the envelope was opened by a blinded investigator.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Implants were randomly inserted in 20 non-lased T2DM patients (Control)

Arm Title

Low level laser therapy

Arm Type

Experimental

Arm Description

Implant were randomly inserted in 20 lased T2DM patients (Intervention)

Intervention Type

Radiation

Intervention Name(s)

low-level laser therapy (LLLT)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Bone density

Description

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.

Time Frame

Week 1

Title

Bone density

Description

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.

Time Frame

Month 1

Title

Bone density

Description

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.

Time Frame

Month 3

Title

Bone density

Description

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.

Time Frame

Month 4

Title

Osteoprotegrin (OPG) level

Description

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.

Time Frame

Week 1

Title

Osteoprotegrin (OPG) level

Description

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.

Time Frame

Month 1

Title

Osteoprotegrin (OPG) level

Description

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.

Time Frame

Month 3

Title

Osteoprotegrin (OPG) level

Description

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.

Time Frame

Month 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Faculty of Dental Medicine for Girls, Al-Azhar University

City

Cairo

Country

Egypt

Facility Name

Misr International University

City

Cairo

Country

Egypt

Facility Name

Misr University for Science and Technology (MUST)

City

Cairo

Country

Egypt

Facility Name

Sinai University

City

El-Arish

Country

Egypt

Facility Name

Delta University of Science and Technology

City

Gamasa

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs