Missing TeethNCT05467488
Light-induced Effects on Dental Implant Stability
A study testing photofunctionalization in people with Missing Teeth, run by Prof. Abdul Mueed Zaigham at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- photofunctionalization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2017to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy patients with age > 20 with at least one tooth or more missing
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Dentistry; CMH Lahore Medical College
Lahore, Punjab Province
About this study
Official title: 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.
- Conditions
- Missing Teeth
- Being tested
- photofunctionalization
- Keywords
- dental implants
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photofunctionalizationProcedure or surgery
UVA and UVC photofunctionalization of dental implants
| Study group | Role | What they receive |
|---|---|---|
| Non irradiated implants (group A) | No intervention | Not described |
| UVA irradiated group (group B) | Active comparator | Not described Receives: Procedure: photofunctionalization |
| UVC irradiated group (group C) | Active comparator | Not described Receives: Procedure: photofunctionalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 Jun 2017
- Primary completion15 Mar 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Abdul Mueed Zaigham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Abdul Mueed Zaigham, CMH Lahore Medical College and Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467488
- Sponsor's protocol ID
- 32/ERC/CMH/LMC
- Status last verified
- Sep 2023
- First submitted
- 13 Jul 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraviolet A and Ultraviolet C Light-induced Effects on Dental Implant Stability
- ClinicalTrials.gov ID
- NCT05467488
- Acronym / sponsor ID
- 32/ERC/CMH/LMC
- Conditions
- Missing Teeth
- Keywords
- dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Prof. Abdul Mueed ZaighamUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- systemically healthy patients with age > 20 with at least one tooth or more missing
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photofunctionalizationUVA and UVC photofunctionalization of dental implants | Procedure or surgery | UVA irradiated group (group B), UVC irradiated group (group C) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photofunctionalization in people with Missing Teeth, run by Prof. Abdul Mueed Zaigham at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ISQ measurement through Ostelltm Mentor device (time frame: eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.