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Photobiomodulation and Implant Stability (low-laser)

T

T.C. Dumlupınar Üniversitesi

Status

Unknown

Conditions

Photobiomodulation Therapy

Treatments

Device: photobiomodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04495335
2020-04/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

Test Group (TG)
Experimental group
Description:
The study included test group with Photobiomodulation treatment after dental implant surgery
Treatment:
Device: photobiomodulation
Control Group (CG)
Active Comparator group
Description:
The control group consisted of laser application without energy delivery to the tissue.
Treatment:
Device: photobiomodulation

Trial contacts and locations

1

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Central trial contact

Berceste Guler, PhD

Data sourced from clinicaltrials.gov

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