NCT04495335

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 26, 2020

Last Update Submit

July 29, 2020

Conditions

Photobiomodulation Therapy

Keywords

Low-level laser therapy implants

Outcome Measures

Primary Outcomes (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.

    The stability was measured at immediately postoperatively.

  • 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.

    The stability was measured at 30 days postoperatively.

  • 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.

    The stability was measured at 60 days postoperatively.

  • 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.

    The stability was measured at 90 days postoperatively.

Secondary Outcomes (2)

  • Evaluation of the number of peri-implant total microorganisms by PCR

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

  • Evaluation of the number of peri-implant total microorganisms by PCR

    Microbiological samples will obtained at the 90 days after implant surgery

Study Arms (2)

Test Group (TG)

EXPERIMENTAL

The study included test group with Photobiomodulation treatment after dental implant surgery

Device: photobiomodulation

Control Group (CG)

ACTIVE COMPARATOR

The control group consisted of laser application without energy delivery to the tissue.

Device: photobiomodulation

Interventions

photobiomodulationDEVICE

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.

Also known as: low-level laser therapy
Control Group (CG)Test Group (TG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 16672018BACKGROUND

  • 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.

    PMID: 17523169BACKGROUND

  • 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.

    PMID: 25653816BACKGROUND

  • 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.

    PMID: 33851765DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Suleyman Bozkaya, DDS PhD

    Gazi University Faculty of Dentistry

    STUDY DIRECTOR

Central Study Contacts

Berceste Guler, PhD

CONTACT

905059359207berceste.guler@ksbu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS PhD, Assist Prof

Study Record Dates

First Submitted

July 26, 2020

First Posted

July 31, 2020

Study Start

January 1, 2020

Primary Completion

September 30, 2020

Study Completion

October 30, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)