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

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05222737
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Periodontal Pocket	Device: medency diode laser; Drug: spirazole forte	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Sep 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria [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

Secondary Outcome Measures

1. comparing levels of bacteria between test and control groups [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.

Other Outcome Measures

1. Probing depth(PPD) [Baseline ,one month and 3 months]

   Measure PPD at baseline and after treatment

2. Clinical Attachment loss(CAL) [Baseline ,one month and 3 months]

   Measure CAL at baseline and after treatment

3. Mobility grade [Baseline ,one month and 3 months]

   Measure mobility grade at baseline and after treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amira Hafez	Alexandria		Egypt

Sponsors and Collaborators

• Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: amira hafez, Resident at department of periodontolgy. Alexandria university, Alexandria University
• ClinicalTrials.gov Identifier: NCT05222737
• Other Study ID Numbers: lasers in periodontology
• First Posted: Feb 3, 2022
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Periodontal Pocket

Study Results

No Results Posted as of Jul 6, 2022