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T2DM (Type 2 Diabetes Mellitus)NCT05279911

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

A study testing low-level laser therapy (LLLT) in people with T2DM (Type 2 Diabetes Mellitus) and Low-level Laser Therapy, run by Sinai University at 5 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
low-level laser therapy (LLLT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesEgypt
Study dates
3 Mar 2021to 22 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

Egypt5 sites

  • Faculty of Dental Medicine for Girls, Al-Azhar University

    Cairo

  • Misr International University

    Cairo

  • Misr University for Science and Technology (MUST)

    Cairo

  • Sinai University

    El Arish

  • Delta University of Science and Technology

    Gamasa

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
low-level laser therapy (LLLT)
Keywords
T2DM (Type 2 Diabetes Mellitus), Dental Implant insertion, Osteoprotegrin (OPG), Bone Density, Low-level laser therapy, LLLT
Medical subject headings
Diabetes Mellitus, Type 2, Osteosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT05279911
Study groupRoleWhat they receive
ControlNo interventionImplants were randomly inserted in 20 non-lased T2DM patients (Control)
Low level laser therapyExperimentalImplant were randomly inserted in 20 lased T2DM patients (Intervention)
Receives: Radiation: low-level laser therapy (LLLT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 1

  2. 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.

    Measured: Month 1

  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.

    Measured: Month 3

  4. 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.

    Measured: Month 4

  5. 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.

    Measured: Week 1

  6. 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.

    Measured: Month 1

  7. 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.

    Measured: Month 3

  8. 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.

    Measured: Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start3 Mar 2021
  3. Primary completion5 Jan 2022
  4. Study completion22 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279911
Sponsor's protocol ID
FWA00025577
Status last verified
Mar 2022
First submitted
24 Feb 2022
Last updated
15 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37102010

Questions about this trial

What is this clinical trial studying?

A study testing low-level laser therapy (LLLT) in people with T2DM (Type 2 Diabetes Mellitus) and Low-level Laser Therapy, run by Sinai University at 5 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone density (time frame: Week 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05279911, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.

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