Implant Site ReactionEPIDNCT06724107
Photofunctionalization With UVC
A study testing UVC in people with Implant Site Reaction, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Summary: Objective: The general objective is to compare the placement of standard implants with a surface photofunctionalization technique based on ultraviolet C radiation (UVC), having as working hypothesis that this photofunctionalization will accelerate the bone apposition on the implant surface and increase the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- UVC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2024to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Patients requiring dental implant surgery with or without bone or soft tissue regeneration surgery.
- Acceptance of the informed consent document.
Who cannot join
- Subjects with systemic diseases leading to untreated or uncontrolled haemostasis or coagulation disturbances.
- Subjects with active infectious diseases (tuberculosis, HIV, syphilis, hepatitis, etc).
- Patients under pharmacological treatment with monoclonal antibodies, bisphosphonates, chemotherapy or prolonged treatment with corticoids.
- Patients with alcoholism or drug addiction.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Jesus Torres
Madrid
Jesus Torres, PhD, 653050071 ext. +34, jesus.torres@ucm.es
About this study
Official title: Effect of Photofunctionalization With on Titanium Dental Implants. A Pilot Sutdy
Summary:
Objective: The general objective is to compare the placement of standard implants with a surface photofunctionalization technique based on ultraviolet C radiation (UVC), having as working hypothesis that this photofunctionalization will accelerate the bone apposition on the implant surface and increase the amount of bone that binds to the implant, making it possible to load these photofunctionalized implants in less time.
Read more
Design: Pilot, clinical, randomized, prospective, controlled, single-center, prospective study.
Scope of the study: Master's Degree in Oral Surgery and Implantology. Faculty of Dentistry. Complutense University of Madrid.
Subjects of the study: patients attending the Master's Degree in Oral Surgery and Implantology for rehabilitation with dental implants, regardless of the sector in which they have missing teeth.
Key words: ISQ (implant stability quotient), inmediate loading, UVC, dental implants.
- Conditions
- Implant Site Reaction
- Being tested
- UVC
- Keywords
- ISQ (implant stability quotient), inmediate loading, UVC, dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVCRadiation
It is proposed to evaluate and compare the ISQ at 1 week, 2 weeks, 3 weeks and 4 weeks in patients undergoing implant placement surgery by comparing photofunctionalised (study group) and non-photofunctionalised (control group) implants in both native bone and grafted bone. To assess whether immediate loading can be carried out before 4 weeks and how long the waiting time for implant loading can be reduced, by performing predictability curves.
| Study group | Role | What they receive |
|---|---|---|
| UVC group | Experimental | photofunctionalised (study group) implants Receives: Radiation: UVC |
| Control group | Placebo comparator | non-photofunctionalised (control group) implants Receives: Radiation: UVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone regeneration
Bone implant contact (BIC) Histotogic parameter in percentage
Measured: 3 months
Secondary outcomes (1)
ISQ and marginal bone loss
Implant stability quotient and marginal bone loss measure with X-rays (quantitative parameter)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start12 Dec 2024 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Model description
- randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Torres García Denche, Universidad Complutense de Madrid
- Investigators
- isabel leco, PhD, Study director, UCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724107
- Sponsor's protocol ID
- C.I. 23/523-EC_P
- Acronym
- EPID
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photofunctionalization With on Titanium Dental Implants. A Pilot Sutdy
- ClinicalTrials.gov ID
- NCT06724107
- Acronym / sponsor ID
- EPID / C.I. 23/523-EC_P
- Conditions
- Implant Site Reaction
- Keywords
- ISQ (implant stability quotient), inmediate loading, UVC, dental implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 12 Dec 2024 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
Summary:
Objective: The general objective is to compare the placement of standard implants with a surface photofunctionalization technique based on ultraviolet C radiation (UVC), having as working hypothesis that this photofunctionalization will accelerate the bone apposition on the implant surface and increase the amount of bone that binds to the implant, making it possible to load these photofunctionalized implants in less time.
Design: Pilot, clinical, randomized, prospective, controlled, single-center, prospective study.
Scope of the study: Master's Degree in Oral Surgery and Implantology. Faculty of Dentistry. Complutense University of Madrid.
Subjects of the study: patients attending the Master's Degree in Oral Surgery and Implantology for rehabilitation with dental implants, regardless of the sector in which they have missing teeth.
Key words: ISQ (implant stability quotient), inmediate loading, UVC, dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| UVC group | Experimental | Radiation: UVCphotofunctionalised (study group) implants |
| Control group | Placebo comparator | Radiation: UVCnon-photofunctionalised (control group) implants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age.
- Patients requiring dental implant surgery with or without bone or soft tissue regeneration surgery.
- Acceptance of the informed consent document.
Key exclusion criteria (5 listed)
- Subjects with systemic diseases leading to untreated or uncontrolled haemostasis or coagulation disturbances.
- Subjects with active infectious diseases (tuberculosis, HIV, syphilis, hepatitis, etc).
- Patients under pharmacological treatment with monoclonal antibodies, bisphosphonates, chemotherapy or prolonged treatment with corticoids.
- Patients with alcoholism or drug addiction.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| UVCIt is proposed to evaluate and compare the ISQ at 1 week, 2 weeks, 3 weeks and 4 weeks in patients undergoing implant placement surgery by comparing photofunctionalised (study group) and non-photofunctionalised (control group) implants in both native bone and grafted bone. To assess whether immediate loading can be carried out before 4 weeks and how long the waiting time for implant loading can be reduced, by performing predictability curves. | Radiation | Control group, UVC group |
Primary outcome
Bone regeneration
Time frame: 3 months
Bone implant contact (BIC) Histotogic parameter in percentage
1 secondary outcome
ISQ and marginal bone loss
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
isabel leco, PhD study director
UCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVC in people with Implant Site Reaction, run by Universidad Complutense de Madrid at 1 site in Spain.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jesus gd torres, PhD (+34653050071 ext. 34, jesus.torres@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone regeneration (time frame: 3 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 9 Dec 2024.