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Clinical Trials/CTRI/2024/12/078406
CTRI/2024/12/078406
Active, not recruiting
Phase 2/3

EVALUATION OF EFFECT OF PHOTO BIOMODULATION WITH LOW LEVEL LASER THERAPY AND HISTO MORPHOMETRIC ANALYSIS AROUND DENTAL IMPLANTS

Vanapamala Gnana kusumanjali1 site in 1 country28 target enrollmentStarted: January 2, 2025Last updated:

Overview

Phase
Phase 2/3
Status
Active, not recruiting
Sponsor
Vanapamala Gnana kusumanjali
Enrollment
28
Locations
1
Primary Endpoint
Scanning Electron Microscopic Analysis

Overview

Brief Summary

This study aimed to evaluate the effect of photobiomodulation by low level laser therapy and histomorphometric analysis in dental implants. The current study is a double-masked, randomized clinical trial. A total of 28

patients of age 25 to 55 years were assigned randomly into two groups. Group I: 14 osteotomy sites were treated with low level laser. Group B: 14 Osteotomy sites were not treated with low level laser. bone samples were collected using trephine drill during initial osteotomy and during 2nd stage of implant and samples will be subjected to SEM analysis to know bony architecture and EDX analysis will be done for calcium and phosphorous analysis. Implant  stability will be measured by using Penguin RFA device.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
25.00 Year(s) to 55.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Implants in Partially/ Completely edentulous sites in maxilla or mandible.
  • Good systemic health.

Exclusion Criteria

  • Any systemic disease that affects the periodontium were contraindicated for implant placement.
  • Inability or unwillingness to complete the trial.
  • Patients on any medication that could affect or alter the course of periodontal treatment.
  • Poor oral hygiene.
  • • Pregnant, Lactating mothers.
  • • History of smoking and alcohol abuse.

Outcomes

Primary Outcomes

Scanning Electron Microscopic Analysis

Time Frame: Scanning Electron Microscopic Analysis at baseline and at 6months | Energy-Dispersive X-ray Spectroscopy at baseline and at 6months

Energy-Dispersive X-ray Spectroscopy

Time Frame: Scanning Electron Microscopic Analysis at baseline and at 6months | Energy-Dispersive X-ray Spectroscopy at baseline and at 6months

Secondary Outcomes

  • implant stability using resonance frequency analysis(pain scale)

Investigators

Sponsor
Vanapamala Gnana kusumanjali
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

VANAPAMALA GNANA KUSUMANJALI

St. Joseph dental college

Study Sites (1)

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