Photobiomodulation and Implant Stability

NCT ID: NCT04495335

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Photobiomodulation Therapy

Keywords

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Low-level laser therapy implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test Group (TG)

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

Group Type EXPERIMENTAL

photobiomodulation

Intervention Type DEVICE

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.

Control Group (CG)

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

Group Type ACTIVE_COMPARATOR

photobiomodulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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low-level laser therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

T.C. Dumlupınar Üniversitesi

OTHER

Sponsor Role lead

Responsible Party

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Berceste Guler

DDS PhD, Assist Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suleyman Bozkaya, DDS PhD

Role: STUDY_DIRECTOR

Gazi University Faculty of Dentistry

Locations

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Kütahya Health Sciences University Faculty of Dentistry

Kütahya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berceste Guler, PhD

Role: CONTACT

Phone: 905059359207

Email: [email protected]

Facility Contacts

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Berceste Guler, DDs PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 16672018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17523169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25653816 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33851765 (View on PubMed)

Other Identifiers

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2020-04/01

Identifier Type: -

Identifier Source: org_study_id