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

NCT05279911 | Completed

• 1 other identifier: FWA00025577
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Low level laser therapy

EXPERIMENTAL

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

Radiation: low-level laser therapy (LLLT)

Interventions

low-level laser therapy (LLLT) RADIATION

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).

Low level laser therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinai University: lead
• Misr International University: collaborator
• Al-Azhar University: collaborator
• Delta University for Science and Technology: collaborator

Study Sites (5)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

Location

Misr International University

Cairo, Egypt

Location

Misr University for Science and Technology (MUST)

Cairo, Egypt

Location

Sinai University

El Arish, Egypt

Location

Delta University of Science and Technology

Gamasa, Egypt

Location

Related Publications (1)

• Attia MS, Elewa GM, Abdelgawad N, Ismail RM, Hassan Eid M, Ghoneim MM. The Influence of Low-Level Laser Therapy on CBCT Radiographic and Biochemical Profiles of Type II Controlled Diabetic Patients After Dental Implant Insertion: A Randomized Case-Control Study. Cureus. 2023 Mar 23;15(3):e36559. doi: 10.7759/cureus.36559. eCollection 2023 Mar.

  PMID: 37102010 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Osteosclerosis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Oral and Maxillofacial Surgery

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 15, 2022
• Study Start: March 3, 2021
• Primary Completion: January 5, 2022
• Study Completion: January 22, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (5)