Photobiomodulation and Implant Stability

Photobiomodulation Therapy Clinical Trial

— low-laser  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04495335
• Other study ID #: 2020-04/01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: July 2020
• Source: T.C. Dumlupinar Üniversitesi
• Contact: Berceste Guler, PhD
• Phone: 905059359207
• Email: berceste.guler[@]ksbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Photobiomodulation Therapy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kütahya Health Sciences University Faculty of Dentistry	Kütahya

Sponsors (2)

Lead Sponsor	Collaborator
T.C. Dumlupinar Üniversitesi	Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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.	Microbiological samples will obtained at the first 24-hour after implant surgery
Secondary	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.	Microbiological samples will obtained at the 90 days after implant surgery