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

Periodontal Pocket Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222737
• Other study ID #: lasers in periodontology
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

Intervention

Device:
• medency diode laser
intra pocket application of diode laser

Drug:
• spirazole forte
adminstration of spirazole forte with a dose 17 mg per kg

Locations

Country	Name	City	State
Egypt	Amira Hafez	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Probing depth(PPD)	Measure PPD at baseline and after treatment	Baseline ,one month and 3 months
Other	Clinical Attachment loss(CAL)	Measure CAL at baseline and after treatment	Baseline ,one month and 3 months
Other	Mobility grade	Measure mobility grade at baseline and after treatment	Baseline ,one month and 3 months
Primary	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	baseline
Secondary	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.	baseline