ClinicalTrials.gg
RecruitingNCT06541912Updated Aug 7, 2024

Comparative Evaluation of Implant Stability, Soft & Hard Tissue Healing Around UV Activated vs Conventional Implants

An interventional study of conventional implant and UV implant in UV Dental Implant, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Recruiting at 1 site in India. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Feb 2024, registered Jul 2024).
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • UV Dental Implant

Keywords

  • Dental Implants
03

In context

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • General 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
12 participants (estimated)

Study arms

  • Active comparator
    conventional dental implant group

    conventional dental implant placement will act as control group.

    Procedure: conventional implant

  • Experimental
    UV dental implant group

    UV activated implant placement will act as test group which has better osseointegration properties.

    Procedure: UV implant

Interventions

  • Procedureconventional implant

    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.

  • ProcedureUV implant

    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.

06

What researchers measure

Primary outcomes

  1. Implant stability using Resonance Frequency Analysis

    to measure primary and secondary stability

    Time frame: "Immediately after Post-operative", "1 month", "3 months"

Secondary outcomes

  1. Marginal bone loss using RVG with grid

    to measure marginal bone level

    Time frame: "Immediately after Post-operative", 3 months

  2. 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.

    Time frame: 1 week, 1 month, 3 months.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2024 (actual). Primary completion is estimated for Mar 2026, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2024
First posted
Aug 7, 2024
StartActual
Feb 15, 2024
Primary completionEst.
Mar 25, 2026
CompletionEst.
Mar 25, 2026
Last update
Aug 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06541912
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Aug 7, 2024
Start date
Feb 15, 2024
Primary completion
Mar 25, 2026 (estimated)
Completion
Mar 25, 2026 (estimated)
Last update
Aug 7, 2024

Study contacts

Dr. PRABHUJI MLV, MDS
Contact
prabhujimlv@gmail.com
9448057407
Dr. shailja dutta, mds
Contact
shailjadutta31@gmail.com
7624845840

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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