- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05467488
Light-induced Effects on Dental Implant Stability
September 2, 2023 updated by: Prof. Abdul Mueed Zaigham
Ultraviolet A and Ultraviolet C Light-induced Effects on Dental Implant Stability
Until now, limited research has observed the stability of photo functionalized sandblasted acid-etched (SLA) titanium implants.
The study includes a sample size of sixty otherwise healthy patients with implant replacement, comparing nonirradiated, irradiated UVA and UVC titanium implants.
It was an interventional study with a sample size divided into three groups using simple randomization.
Patients with nonirradiated dental implants make the control group A with UVA and UVC dental implants forming groups B and C, respectively.
Before functional loading, implant stability was measured on days zero and eight weeks.
SPSS 26.0 is used for data analysis.
The data for implant stability quotient (ISQ) levels and osseointegration speed index (OSI) were presented as mean ± SD for each group.
The effect of UVA and UVC on ISQ2 compared with the baseline ISQ was done by applying multiple simple regression analysis models, whereas the distinction between UVA and UVC was made through a t-test.
p ≤ 0.05 was kept statistically significant.
The implants irradiated with UVA significantly affected ISQ levels compared to other groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Institute of Dentistry; CMH Lahore Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- systemically healthy patients with age > 20 with at least one tooth or more missing
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Non irradiated implants (group A)
|
|
|
Active Comparator: UVA irradiated group (group B)
|
UVA and UVC photofunctionalization of dental implants
|
|
Active Comparator: UVC irradiated group (group C)
|
UVA and UVC photofunctionalization of dental implants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ISQ measurement through Ostelltm Mentor device
Time Frame: eight months
|
The Ostelltm device was initially calibrated using a test peg called the ISQ.
A smart peg was used for assessment.
The smart peg tightened with 5 Ncm torque is then mounted on implant fixture and the transducer connected perpendicular to the implant .
The measuring probe is brought closer to the smart peg without touching it.
A beeping sound displays the reading on the monitor.
Two successive readings are taken mesiodistally along the jaw and buccolingually perpendicular to the jaw .The RFA measurements taken twice during implant treatment are recorded.
All the ISQ values were recorded from one to hundred and a mean was taken.
|
eight months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2017
Primary Completion (Actual)
March 15, 2018
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
July 13, 2022
First Submitted That Met QC Criteria
July 19, 2022
First Posted (Actual)
July 20, 2022
Study Record Updates
Last Update Posted (Actual)
September 6, 2023
Last Update Submitted That Met QC Criteria
September 2, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32/ERC/CMH/LMC
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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