EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET

November 17, 2023 updated by: Nourhan M.Aly
Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly extracted sockets augmented by Collaplug in the jumping gap.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Any non-restorable hopeless tooth: badly decayed tooth that cannot be restored. Tooth with failed endodontic treatment and tooth with longitudinal fracture.
  • Type I post-extraction sockets with all bony walls intact.
  • No signs of active periodontal disease in the selected tooth.

Exclusion Criteria:

  • The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
  • The presence of acute periapical infection.
  • The presence of any local factor that may interfere with extraction as tooth ankyloses.
  • Subjects who had undergone therapeutical radiation.
  • Patients who had been subjected to or who were under bisphosphonate therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collaplug application with low level laser application.
Other: Collaplug with low level laser
Immediate implant placement with applying a collaplug material in the jumping gap followed by low level laser application using Siro laser (660 nm, avg. power density: 0.5-WATT) circular spot diameter and area: 0.71 cm/0.4cm2) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing.
Active Comparator: Collaplug application
Other: Collaplug
Implant of suitable diameter and height was placed in the fresh extracted socket immediately after extraction and the jumping gap was augmented by the collaplug followed by healing abutment placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: up to 3 months
Implant stability was measured by OSSTELL at 4 different levels (buccal, lingual, mesial, and distal). Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. Higher levels indicate greater stability.
up to 3 months
Crestal bone loss
Time Frame: up to 3 months
Crestal bone loss was assessed using cone beam computed tomography (CBCT) by measuring the distance from the bone crest to the implant apex from mesial, distal, lingual and buccal aspects intraoperatively. Crestal bone loss up to 1.5 mm is considered a normal early finding through the first year after implant placement.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nourhan M.Aly

Investigators

  • Principal Investigator: Nermine A Elnakib, BDS, Alexandria University
  • Study Chair: Maha R Talaab, PhD, Alexandria University
  • Study Director: Nayrouz A Metwally, PhD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 8, 2023

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • #2/3/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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