Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture

April 19, 2023 updated by: Marwa adel, Mansoura University

Effect of Laser Bio-stimulation on Peri-implant Tissue Health for Mandibular Knife-edge Ridges Managed With One- Stage Ridge Splitting and Two- Implant Mandibular PEEK Overdentures. A One -Year Randomized Controlled Trial

This study was conducted to determine the effectiveness of two-implant retained polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants placed with ridge splitting either treated with laser biostimulation or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomised controlled trial was executed on 18 completely edentulous patients from the Outpatient Clinic of the Faculty of Dentistry at Mansoura University in Egypt.

Study Type

Interventional

Enrollment (Actual)

18

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
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Marwa Adel

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

Yes

Description

Inclusion Criteria:

- eligible patients must have mandibular knife edge ridge

Exclusion Criteria:

  • contraindicated any systemic disease preventing surgical intervention such as bone metabollic disease , diabetes mellitus

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
Active Comparator: control group
patients had ridge splitting without laser bio stimulation and received two implants supported peek overdenture
Procedure: ridge splitting with implant placement
ridge splitting of mandibular denture followed by two implant placement
Active Comparator: study group
patients had ridge splitting with laser bio stimulation and received two implants supported peek overdenture
Procedure: ridge splitting with implant placement
ridge splitting of mandibular denture followed by two implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
crestal bone loss
Time Frame: one year
measuring marginal bone loss arround dental implants in mm by digital radiograph
one year
plaque index
Time Frame: One year
score 0 = no plaque; score1 = plaque only detected with a probe; score 2 = plaque visible to the naked eye; score 3 = abundant plaque1111
One year
bleeding index
Time Frame: one year
score 0: no bleeding when using a periodontal probe; score1: isolated bleeding spots visible; score 2: a confluent red line of blood along the mucosal margin; score 3: heavy or profuse bleeding).
one year
gingival index
Time Frame: one year
Score 0: normal peri implant mucosa; score 1: mild inflammation, slight colour change, and slight edoema; score 2: moderate inflammation, redness, edoema, and glazing; and score 3: severe inflammation, marked redness and edoema, and ulceration.
one year
probing depth
Time Frame: one year
A periodontal probe was used to measure pocket depth (PD). The distance between the marginal border of the mucosa and the tip of the periodontal probe at the base of the gingival sulcus was scored as the probing depth.
one year

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: marwa adel, MD, Mansoura 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)

April 20, 2019

Primary Completion (Actual)

January 13, 2021

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A01100918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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