Evaluation of the Bone Structure Surrounding Photofunctionalized Implants

NCT06821932 | Completed

• 1 other identifier: 36290600/34/2021
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implants

Keywords

Photofunctionalization; Ultraviyolet Light; Dental implant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental: photofunctionalized implant inserted

EXPERIMENTAL

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

Control: Dental implant placement without photofunctionalization process

ACTIVE COMPARATOR

Dental implants were inserted in the bone on the contralateral side of the mouth without photofunctionalization

Procedure: Dental implant surgery

Interventions

Photofunctionalized dental implant surgery PROCEDURE

Dental implants subjected to photofunctionalization were placed in the experimental area of the mouth.

Experimental: photofunctionalized implant inserted

Dental implant surgery PROCEDURE

Dental implants not subjected to photofunctionalization were placed in the bone on the contralateral side of the mouth

Control: Dental implant placement without photofunctionalization process

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University, Faculty of Dentistry

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33969450 BACKGROUND

• 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.

  PMID: 30231097 BACKGROUND

• Farsiani H, Bagis N, Balkan EP, Karacaoglu F, Guner ZD, Orhan K. Evaluation of the bone structure surrounding photofunctionalized implants using the fractal analysis method: a split-mouth randomized clinical study. BMC Oral Health. 2025 Jul 1;25(1):964. doi: 10.1186/s12903-025-06330-6.

  PMID: 40598042 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Splith mouth

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: February 12, 2025
• Study Start: May 15, 2021
• Primary Completion: June 10, 2022
• Study Completion: October 22, 2022
• Last Updated: February 12, 2025

Record last verified: 2021-04

Locations

TU (1)