Photobiomodulation and Implant Stability (low-laser)

July 29, 2020 updated by: Berceste Guler, T.C. Dumlupınar Üniversitesi

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

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

  • Turkey
      • Kütahya, Turkey, 43100
        • Recruiting
        • Kütahya Health Sciences University Faculty of Dentistry
        • Contact:
        • Sub-Investigator:
          • Ahu Uraz, DDS PhD
        • Principal Investigator:
          • Suleyman Bozkaya, DDS PhD

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group (TG)
The study included test group with Photobiomodulation treatment after dental implant surgery
Device: photobiomodulation
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.
Other Names:
  • low-level laser therapy
Active Comparator: Control Group (CG)
The control group consisted of laser application without energy delivery to the tissue.
Device: photobiomodulation
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.
Other Names:
  • low-level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary and secondary implant stability
Time Frame: The stability was measured at immediately postoperatively.
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.
The stability was measured at immediately postoperatively.
primary and secondary implant stability
Time Frame: The stability was measured at 30 days postoperatively.
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.
The stability was measured at 30 days postoperatively.
primary and secondary implant stability
Time Frame: The stability was measured at 60 days postoperatively.
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.
The stability was measured at 60 days postoperatively.
primary and secondary implant stability
Time Frame: The stability was measured at 90 days postoperatively.
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.
The stability was measured at 90 days postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the number of peri-implant total microorganisms by PCR
Time Frame: Microbiological samples will obtained at the first 24-hour after implant surgery
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.
Microbiological samples will obtained at the first 24-hour after implant surgery
Evaluation of the number of peri-implant total microorganisms by PCR
Time Frame: Microbiological samples will obtained at the 90 days after implant surgery
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.
Microbiological samples will obtained at the 90 days after implant surgery

Collaborators and Investigators

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

Sponsor

T.C. Dumlupınar Üniversitesi

Collaborators

Gazi University

Investigators

  • Study Director: Suleyman Bozkaya, DDS PhD, Gazi University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

October 30, 2020

Study Registration Dates

First Submitted

July 26, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-04/01

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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