UV Dental ImplantNCT06541912
Comparative Evaluation of Implant Stability, Soft & Hard Tissue Healing Around UV Activated vs Conventional Implants
A study testing conventional implant and UV implant in people with UV Dental Implant, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- UV Dental Implant
- What is being tested?
- conventional implant and UV implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- 15 Feb 2024to 25 Mar 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At east above 18 years of age
- Patients who needs replacement for at least 2 missing teeth in the posterior region of mandible
- Adequate bone volume to accommodate planned dental implants
- Patients who will comply with oral health care instructions and necessary visits
Who cannot join
- General contraindications to dental implant treatment ( uncontrolled diabetes, severe cardiovascular or infectious disease)
- Intravenous and oral bisphosphonate therapy
- Unwillingness to return for the follow up examinations
- Smokers
- Patients who are psychologically unable to participate
- Poor oral hygiene
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. Prabhuji MLV
Bengaluru, Karnataka, 562157
dr. prabhuji mlv, mds, 9448057407, prabhujimlv@gmail.com
dr. shailja dutta, mds, 7624845840, shailjadutta31@gmail.com
About this study
Official title: Comparative Evaluation of Implant Stability, Soft and Hard Tissue Healing Around UV Activated Versus Conventional Implants - A Randomized Clinical Trial.
Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants.
Read the detailed description
Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants. The objectives are to access the primary and secondary implant stability using Resonance frequency analysis, marginal bone level using RVG with grid, healing of the soft tissue. The control group will be treated with conventional implant and test group will be treated with UV implants. The total number of participants are 12 and 24 sites (control - 12 sites, test - 12 sites) with 3 months follow up.
- Conditions
- UV Dental Implant
- Being tested
- conventional implant, UV implant
- Keywords
- Dental Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional implantProcedure or surgery
A full thickness mucoperiosteal flap was elevated under local anesthesia, osteotomy sites were prepared according to manufacturer's instructions and parallel pin was used to confirm position and angulation of osteotomy site. Conventional implant placement was done on one side.
Resonance frequency analysis instrument was used to measure Implant Stability Quotient (ISQ) and check the primary stability of the implant. The surgical wound closure was done with mattress and single interrupted sutures, using 4-0 vicryl sutures.
UV implantProcedure or surgery
A full thickness mucoperiosteal flap was elevated under local anesthesia and osteotomy sites were prepared according to manufacturer's instructions. Parallel pin was used to confirm position and angulation of osteotomy site. UV implant was activated using UV Activator2 and placed in another site.
Resonance frequency analysis instrument was used to measure Implant Stability Quotient (ISQ) and primary stability of the implant was measured. The surgical wound closure was done with mattress and single interrupted sutures, using 4-0 vicryl sutures.
| Study group | Role | What they receive |
|---|---|---|
| conventional dental implant group | Active comparator | conventional dental implant placement will act as control group. Receives: Procedure: conventional implant |
| UV dental implant group | Experimental | UV activated implant placement will act as test group which has better osseointegration properties. Receives: Procedure: UV implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability using Resonance Frequency Analysis
to measure primary and secondary stability
Measured: "Immediately after Post-operative", "1 month", "3 months"
Secondary outcomes (2)
Marginal bone loss using RVG with grid
to measure marginal bone level
Measured: "Immediately after Post-operative", 3 months
Soft tissue healing
soft tissue healing to be assessed using Landry Turnbull and Howley Healing Index. Soft tissue healing will be scored from 1 to 5, where score 1 is very poor and 5 is excellent.
Measured: 1 week, 1 month, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start15 Feb 2024
- Primary completion25 Mar 2026 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UV Dental ImplantStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541912
- Sponsor's protocol ID
- 02_D012_00048
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 7 Aug 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Implant Stability, Soft and Hard Tissue Healing Around UV Activated Versus Conventional Implants - A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06541912
- Acronym / sponsor ID
- 02_D012_00048
- Conditions
- UV Dental Implant
- Keywords
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 7 Aug 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.
Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants.
Detailed description
Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants. The objectives are to access the primary and secondary implant stability using Resonance frequency analysis, marginal bone level using RVG with grid, healing of the soft tissue. The control group will be treated with conventional implant and test group will be treated with UV implants. The total number of participants are 12 and 24 sites (control - 12 sites, test - 12 sites) with 3 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional dental implant group | Active comparator | Procedure: conventional implantconventional dental implant placement will act as control group. |
| UV dental implant group | Experimental | Procedure: UV implantUV activated implant placement will act as test group which has better osseointegration properties. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At east above 18 years of age
- Patients who needs replacement for at least 2 missing teeth in the posterior region of mandible
- Adequate bone volume to accommodate planned dental implants
- Patients who will comply with oral health care instructions and necessary visits
Key exclusion criteria (6 listed)
- General contraindications to dental implant treatment ( uncontrolled diabetes, severe cardiovascular or infectious disease)
- Intravenous and oral bisphosphonate therapy
- Unwillingness to return for the follow up examinations
- Smokers
- Patients who are psychologically unable to participate
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 |
|---|---|---|
| conventional implantA full thickness mucoperiosteal flap was elevated under local anesthesia, osteotomy sites were prepared according to manufacturer's instructions and parallel pin was used to confirm position and angulation of osteotomy site. Conventional implant placement was done on one side. Resonance frequency analysis instrument was used to measure Implant Stability Quotient (ISQ) and check the primary stability of the implant. The surgical wound closure was done with mattress and single interrupted sutures, using 4-0 vicryl sutures. | Procedure or surgery | conventional dental implant group |
| UV implantA full thickness mucoperiosteal flap was elevated under local anesthesia and osteotomy sites were prepared according to manufacturer's instructions. Parallel pin was used to confirm position and angulation of osteotomy site. UV implant was activated using UV Activator2 and placed in another site. Resonance frequency analysis instrument was used to measure Implant Stability Quotient (ISQ) and primary stability of the implant was measured. The surgical wound closure was done with mattress and single interrupted sutures, using 4-0 vicryl sutures. | Procedure or surgery | UV dental implant group |
Primary outcome
Implant stability using Resonance Frequency Analysis
Time frame: "Immediately after Post-operative", "1 month", "3 months"
to measure primary and secondary stability
2 secondary outcomes
Marginal bone loss using RVG with grid
Time frame: "Immediately after Post-operative", 3 months
Soft tissue healing
Time frame: 1 week, 1 month, 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional implant and UV implant in people with UV Dental Implant, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Aug 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. PRABHUJI MLV, MDS (9448057407, prabhujimlv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability using Resonance Frequency Analysis (time frame: "Immediately after Post-operative", "1 month", "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 7 Aug 2024.