Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser
Primary Purpose
Periodontal Pocket
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
medency diode laser
spirazole forte
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Pocket
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes having severe periodontitis (stage 3 grade C) with interdental clinical attachment loss (CAL) ≥ 5.
- Patients' age between 15 and 35 years old with rapid bone loss showed by radiograph.
- Systemically healthy patients.
- Radiographic bone loss extending to middle or apical third of root.
- Probing depth (PD) ≥ 6 mm.
Exclusion Criteria:
- Use of antibiotics during the last 3 months.
- Pregnancy.
- Any systemic condition that might affect the study.
- Use of mouthwash containing antimicrobials during the previous 3 weeks.
- Smoking.
Sites / Locations
- Amira Hafez
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
test group
control group
Arm Description
intra pocket diode laser application
antibiotic adminstration
Outcomes
Primary Outcome Measures
Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria
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
Secondary Outcome Measures
comparing levels of bacteria between test and control groups
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05222737
Brief Title
Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
to measure clinical parameters probing depth,attachment loss and mobility grade
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Active Comparator
Arm Description
intra pocket diode laser application
Arm Title
control group
Arm Type
Active Comparator
Arm Description
antibiotic adminstration
Intervention Type
Device
Intervention Name(s)
medency diode laser
Intervention Description
intra pocket application of diode laser
Intervention Type
Drug
Intervention Name(s)
spirazole forte
Intervention Description
adminstration of spirazole forte with a dose 17 mg per kg
Primary Outcome Measure Information:
Title
Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria
Description
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
Time Frame
baseline
Secondary Outcome Measure Information:
Title
comparing levels of bacteria between test and control groups
Description
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.
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
Probing depth(PPD)
Description
Measure PPD at baseline and after treatment
Time Frame
Baseline ,one month and 3 months
Title
Clinical Attachment loss(CAL)
Description
Measure CAL at baseline and after treatment
Time Frame
Baseline ,one month and 3 months
Title
Mobility grade
Description
Measure mobility grade at baseline and after treatment
Time Frame
Baseline ,one month and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes having severe periodontitis (stage 3 grade C) with interdental clinical attachment loss (CAL) ≥ 5.
Patients' age between 15 and 35 years old with rapid bone loss showed by radiograph.
Systemically healthy patients.
Radiographic bone loss extending to middle or apical third of root.
Probing depth (PD) ≥ 6 mm.
Exclusion Criteria:
Use of antibiotics during the last 3 months.
Pregnancy.
Any systemic condition that might affect the study.
Use of mouthwash containing antimicrobials during the previous 3 weeks.
Smoking.
Facility Information:
Facility Name
Amira Hafez
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser
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