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AzTrials

Photobiomodulation Therapylow-laserNCT04495335

Photobiomodulation and Implant Stability

A study testing photobiomodulation in people with Photobiomodulation Therapy, run by T.C. Dumlupınar Üniversitesi at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective: The aim of the present study was to address the following questions: does photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around dental implants in the early stage of osseointegration. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Photobiomodulation Therapy
What is being tested?
photobiomodulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 30 Oct 2020
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • at least one tooth loss in left and right posterior sides of upper and lower jaws
  • adequate alveolar bone volume as horizontal and vertical

Who cannot join

  • uncontrolled systemic diseases
  • parafunctional (bruxism and/or clenching)
  • smoking habits
  • any allergies or metabolic bone diseases,
  • pregnancy
  • surgical periodontal treatment in 6 months
  • using antibiotics in the last 6 months

Trial locations and contacts

1 site in 1 country.

Berceste Guler, PhD contact

905059359207

berceste.guler@ksbu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Kütahya Health Sciences University Faculty of Dentistry

    Kütahya, 43100

    Berceste Guler, DDs PhD, 905059359207, berceste.guler@ksbu.edu.tr

    Ahu Uraz, DDS PhD

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Photobiomodulation Application on Implant Stabilization and Peri-implant Microbiology

Objective: The aim of the present study was to address the following questions: does photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around dental implants in the early stage of osseointegration.

Material and Methods: Implants will randomly be divided into two groups and implants will be placed in the test group treating with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants are not irradiated. The primary stability of the implants will measure by the Resonance frequency analysis (RFA) after insertion and the secondary stability values will record at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). Plaque samples will collect for microbiological analyzes at the first 24 hours after implant surgery and six days after 90 days at six sterile endodontic paper points.

Read the detailed description

The same surgical procedure will be operated in the test and control groups by the same surgeon. Full-thickness flaps were raised and dental implant osteotomy preparation will be completed according to the manufacturers' instructions. Laser treatment will be completed using Gallium-Aluminum-Arsenide diode laser. The photobiomodulation application will v-be completed by laser energy immediately and three times a week for just 15 days after surgery. The control group will consist of laser application without energy delivery to the tissue. Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer will be applied for direct measurement of implant stability and the value will be recorded. The microbiological plaque samples will be collected at specific times, according to the following schedule; at the first 24-hour and 90 days after implant surgery. All bacterial DNA specimen will be analyzed with qPCR technique to evaluate Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) , Tannerella forsythia (Tf ) and total amount of bacteria.

Being tested
photobiomodulation
Keywords
Low-level laser therapy implants

What participants receive

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

  • photobiomodulationDevice

    Also called low-level laser therapy

    Laser treatment will complete using Gallium-Aluminum-Arsenide (GaA1As) diode laser and application will complete by laser energy immediately and three times a week for just 15 days after surgery.

Study groups in NCT04495335
Study groupRoleWhat they receive
Test Group (TG)ExperimentalThe study included test group with Photobiomodulation treatment after dental implant surgery
Receives: Device: photobiomodulation
Control Group (CG)Active comparatorThe control group consisted of laser application without energy delivery to the tissue.
Receives: Device: photobiomodulation

What is being measured

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

  1. primary and secondary implant stability

    Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.

    Measured: The stability was measured at immediately postoperatively.

  2. primary and secondary implant stability

    Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.

    Measured: The stability was measured at 30 days postoperatively.

  3. primary and secondary implant stability

    Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.

    Measured: The stability was measured at 60 days postoperatively.

  4. primary and secondary implant stability

    Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.

    Measured: The stability was measured at 90 days postoperatively.

Secondary outcomes (2)

  1. Evaluation of the number of peri-implant total microorganisms by PCR

    The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.

    Measured: Microbiological samples will obtained at the first 24-hour after implant surgery

  2. Evaluation of the number of peri-implant total microorganisms by PCR

    The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.

    Measured: Microbiological samples will obtained at the 90 days after implant surgery

Timeline

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

  1. First posted31 Jul 2020
  2. Study start1 Jan 2020
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion30 Oct 2020 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Implants were randomly divided into two groups and implants placed in the test group were treated with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants were not irradiated.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04495335
Sponsor's protocol ID
2020-04/01
Acronym
low-laser
Status last verified
Jul 2020
First submitted
26 Jul 2020
Last updated
31 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lioubavina-Hack N, Lang NP, Karring T. Significance of primary stability for osseointegration of dental implants. Clin Oral Implants Res. 2006 Jun;17(3):244-50. doi: 10.1111/j.1600-0501.2005.01201.x.

    PubMed 16672018

  • Kim YD, Kim SS, Hwang DS, Kim SG, Kwon YH, Shin SH, Kim UK, Kim JR, Chung IK. Effect of low-level laser treatment after installation of dental titanium implant-immunohistochemical study of RANKL, RANK, OPG: an experimental study in rats. Lasers Surg Med. 2007 Jun;39(5):441-50. doi: 10.1002/lsm.20508.

    PubMed 17523169

  • Amid R, Kadkhodazadeh M, Ahsaie MG, Hakakzadeh A. Effect of low level laser therapy on proliferation and differentiation of the cells contributing in bone regeneration. J Lasers Med Sci. 2014 Fall;5(4):163-70.

    PubMed 25653816

  • Bozkaya S, Uraz A, Guler B, Kahraman SA, Turhan Bal B. The stability of implants and microbiological effects following photobiomodulation therapy with one-stage placement: A randomized, controlled, single-blinded, and split-mouth clinical study. Clin Implant Dent Relat Res. 2021 Jun;23(3):329-340. doi: 10.1111/cid.12999. Epub 2021 Apr 14.

    PubMed 33851765

Questions about this trial

What is this clinical trial studying?

A study testing photobiomodulation in people with Photobiomodulation Therapy, run by T.C. Dumlupınar Üniversitesi at 1 site in Turkey (Türkiye).

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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

Results are not available in the source record.

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

Contact Berceste Guler, PhD (905059359207, berceste.guler@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary and secondary implant stability (time frame: The stability was measured at immediately postoperatively.). The study lists 4 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 NCT04495335, which also lists 4 linked publications.

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 31 Jul 2020.

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