NCT05467488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

July 13, 2022

Last Update Submit

September 2, 2023

Conditions

Keywords

dental implants

Outcome Measures

Primary Outcomes (1)

  • 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.

    eight months

Study Arms (3)

Non irradiated implants (group A)

NO INTERVENTION

UVA irradiated group (group B)

ACTIVE COMPARATOR
Procedure: photofunctionalization

UVC irradiated group (group C)

ACTIVE COMPARATOR
Procedure: photofunctionalization

Interventions

UVA and UVC photofunctionalization of dental implants

UVA irradiated group (group B)UVC irradiated group (group C)

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • systemically healthy patients with age \> 20 with at least one tooth or more missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Dentistry; CMH Lahore Medical College

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 20, 2022

Study Start

June 15, 2017

Primary Completion

March 15, 2018

Study Completion

June 15, 2018

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations