Evaluation of the Bone Structure Surrounding Photofunctionalized Implants

Evaluation of the Bone Structure Surrounding Photofunctionalized Implants Using the Fractal Analysis Method: a Split-mouth Randomised Clinical Trial

Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.

Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044<0.05) and the bone fractal score increased.

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: Photofunctionalized dental implant surgery; Procedure: Dental implant surgery

Detailed Description

Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.

Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044<0.05) and the bone fractal score increased.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06500
      • Ankara University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being over the age of 18
• Having bilateral edentulous areas in the posterior mandibular region

Exclusion Criteria:

• Individuals with any systemic disease,
• Individuals using drugs that affect bone metabolism,
• Patients with findings that could affect the study results such as bone cysts, tumors, lesions or fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: photofunctionalized implant inserted; Dental implants were subjected to the photofunctionalization process and then immediately inserted into the bone on the experimental side of the mouth	Procedure: Photofunctionalized dental implant surgery; Dental implants subjected to photofunctionalization were placed in the experimental area of the mouth.
Active Comparator: Control: Dental implant placement without photofunctionalization process; Dental implants were inserted in the bone on the contralateral side of the mouth without photofunctionalization	Procedure: Dental implant surgery; Dental implants not subjected to photofunctionalization were placed in the bone on the contralateral side of the mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone fractal analysis	The bone fractal dimension (FB) values were determined by sizing the ROI to 25x25 pixels using the box counting method. The area of interest to be examined in the image was cropped and saved in 8-bit format. Different image processing methods were applied. For the fractal dimension calculation the box counting method was used. The number of squares containing trabeculae and the total number of squares in the image were determined for various pixel sizes. These values were plotted on a logarithmic scale, and the slope of the line that best fit the points on the graph determined the bone FB.	1 month

Collaborators and Investigators

• Sponsor: Ankara University

Publications and helpful links

General Publications

• Choi B, Lee YC, Oh KC, Lee JH. Effects of photofunctionalization on early osseointegration of titanium dental implants in the maxillary posterior region: a randomized double-blinded clinical trial. Int J Implant Dent. 2021 May 10;7(1):37. doi: 10.1186/s40729-021-00318-x.
• Hirota M, Ozawa T, Iwai T, Ogawa T, Tohnai I. Effect of Photofunctionalization on Early Implant Failure. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):1098-1102. doi: 10.11607/jomi.6541.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): October 22, 2022

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Dental implant; Photofunctionalization; Ultraviyolet Light
• Other Study ID Numbers: 36290600/34/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No