Light-induced Effects on Dental Implant Stability
Primary Purpose
Missing Teeth
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
photofunctionalization
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth focused on measuring dental implants
Eligibility Criteria
Inclusion Criteria:
- systemically healthy patients with age > 20 with at least one tooth or more missing
Exclusion Criteria:
-
Sites / Locations
- Institute of Dentistry; CMH Lahore Medical College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Non irradiated implants (group A)
UVA irradiated group (group B)
UVC irradiated group (group C)
Arm Description
Outcomes
Primary Outcome Measures
ISQ measurement through Ostelltm Mentor device
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05467488
First Posted
July 13, 2022
Last Updated
September 2, 2023
Sponsor
Prof. Abdul Mueed Zaigham
1. Study Identification
Unique Protocol Identification Number
NCT05467488
Brief Title
Light-induced Effects on Dental Implant Stability
Official Title
Ultraviolet A and Ultraviolet C Light-induced Effects on Dental Implant Stability
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Abdul Mueed Zaigham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
Keywords
dental implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non irradiated implants (group A)
Arm Type
No Intervention
Arm Title
UVA irradiated group (group B)
Arm Type
Active Comparator
Arm Title
UVC irradiated group (group C)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
photofunctionalization
Intervention Description
UVA and UVC photofunctionalization of dental implants
Primary Outcome Measure Information:
Title
ISQ measurement through Ostelltm Mentor device
Description
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.
Time Frame
eight months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
systemically healthy patients with age > 20 with at least one tooth or more missing
Exclusion Criteria:
-
Facility Information:
Facility Name
Institute of Dentistry; CMH Lahore Medical College
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Light-induced Effects on Dental Implant Stability
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