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NCT Number: NCT06541912

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

Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants.

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Key information

Conditions

UV Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

conventional implant

Procedure

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 implant

Procedure

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.

Primary outcomes

  1. Implant stability using Resonance Frequency Analysis

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

    to measure primary and secondary stability

Secondary outcomes

  1. Marginal bone loss using RVG with grid

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

    to measure marginal bone level

  2. Soft tissue healing

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. PRABHUJI MLV, MDS

CONTACT

[email protected]

9448057407

Dr. shailja dutta, mds

CONTACT

[email protected]

7624845840

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

Comparative Evaluation of Implant Stability, Soft and Hard Tissue Healing Around UV Activated Versus Conventional Implants - A Randomized Clinical Trial.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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