NCT06541912

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

July 19, 2024

Last Update Submit

August 2, 2024

Conditions

Keywords

Dental Implants

Outcome Measures

Primary Outcomes (1)

  • Implant stability using Resonance Frequency Analysis

    to measure primary and secondary stability

    "Immediately after Post-operative", "1 month", "3 months"

Secondary Outcomes (2)

  • Marginal bone loss using RVG with grid

    "Immediately after Post-operative", 3 months

  • Soft tissue healing

    1 week, 1 month, 3 months.

Study Arms (2)

conventional dental implant group

ACTIVE COMPARATOR

conventional dental implant placement will act as control group.

Procedure: conventional implant

UV dental implant group

EXPERIMENTAL

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

Procedure: UV implant

Interventions

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.

conventional dental implant group
UV implantPROCEDURE

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.

UV dental implant group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Prabhuji MLV

Bengaluru, Karnataka, 562157, India

RECRUITING

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Central Study Contacts

Dr. PRABHUJI MLV, MDS

CONTACT

Dr. shailja dutta, mds

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 7, 2024

Study Start

February 15, 2024

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

August 7, 2024

Record last verified: 2024-08

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