Photobiomodulation and Implant Stability

Not Applicable

• Conditions: Photobiomodulation Therapy
• Interventions: Device: photobiomodulation

• Registration Number: NCT04495335
• Lead Sponsor: T.C. Dumlupınar Üniversitesi

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.

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 Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-29
• Last Update Submitted: 2020-07-29
• Study First Posted: 2020-07-31
• Last Update Posted: 2020-07-31
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
primary and secondary implant stability	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the number of peri-implant total microorganisms by PCR	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.

Trial Locations

Locations (1)

Kütahya Health Sciences University Faculty of Dentistry; 🇹🇷 Kütahya, Turkey