Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser

July 1, 2022 updated by: amira hafez, Alexandria University

Quantitave Assessment of Aggregatibacter Actinomycetemcomitans and Porphyromonas Gingivalis by Real -Time PCR Following Application of Diode Laser in Severe Periodontitis (A RANDIOMIZED CONTROLLED CLINICAL TRIAL)

  1. Primary objective To measure the gingival crevicular levels of A.actinomycetemcomitans and P.gingivalis after intra-pocket application of diode laser in severe periodontitis (stage 3 grade C) patients.
  2. Secondary objective To compare the levels of the same microorganisms as in cases of diode laser therapy to those after conventional treatment with systemic antibiotic administration in severe periodontitis (stage 3 grade C) patients.
  3. to measure clinical parameters probing depth,attachment loss and mobility grade

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

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
        • Amira Hafez

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

15 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of both sexes having severe periodontitis (stage 3 grade C) with interdental clinical attachment loss (CAL) ≥ 5.
  2. Patients' age between 15 and 35 years old with rapid bone loss showed by radiograph.
  3. Systemically healthy patients.
  4. Radiographic bone loss extending to middle or apical third of root.
  5. Probing depth (PD) ≥ 6 mm.

Exclusion Criteria:

  1. Use of antibiotics during the last 3 months.
  2. Pregnancy.
  3. Any systemic condition that might affect the study.
  4. Use of mouthwash containing antimicrobials during the previous 3 weeks.
  5. Smoking.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: test group
intra pocket diode laser application
Device: medency diode laser
intra pocket application of diode laser
ACTIVE_COMPARATOR: control group
antibiotic adminstration
Drug: spirazole forte
adminstration of spirazole forte with a dose 17 mg per kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria
Time Frame: baseline
To measure the gingival crevicular levels of A.actinomycetemcomitans and P.gingivalis after intra-pocket application of diode laser in severe periodontitis(stage 3 grade C) patients
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparing levels of bacteria between test and control groups
Time Frame: baseline
To compare the levels of the same microorganisms as in cases of diode laser therapy to those after conventional treatment with systemic antibiotic administration in severe periodontitis ( stage 3 grade C) patients.
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth(PPD)
Time Frame: Baseline ,one month and 3 months
Measure PPD at baseline and after treatment
Baseline ,one month and 3 months
Clinical Attachment loss(CAL)
Time Frame: Baseline ,one month and 3 months
Measure CAL at baseline and after treatment
Baseline ,one month and 3 months
Mobility grade
Time Frame: Baseline ,one month and 3 months
Measure mobility grade at baseline and after treatment
Baseline ,one month and 3 months

Collaborators and Investigators

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

Sponsor

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)

January 1, 2021

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (ACTUAL)

February 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lasers in periodontology

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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