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

NCT ID: NCT06541912

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2026-03-25

Brief Summary

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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

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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

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UV Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional dental implant group

conventional dental implant placement will act as control group.

Group Type ACTIVE_COMPARATOR

conventional implant

Intervention Type 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 dental implant group

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

Group Type EXPERIMENTAL

UV implant

Intervention Type 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.

Interventions

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conventional 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.

Intervention Type PROCEDURE

UV 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. Prabhuji MLV

Bengaluru, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. PRABHUJI MLV, MDS

Role: CONTACT

9448057407

Dr. shailja dutta, mds

Role: CONTACT

7624845840

Facility Contacts

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dr. prabhuji mlv, mds

Role: primary

9448057407

dr. shailja dutta, mds

Role: backup

7624845840

Other Identifiers

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02_D012_00048

Identifier Type: -

Identifier Source: org_study_id

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