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

NCT05222737 | Completed Phase 2

• 1 other identifier: lasers in periodontology
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.to measure clinical parameters probing depth,attachment loss and mobility grade

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• comparing levels of bacteria between test and control groups

  baseline

Other Outcomes (3)

• Probing depth(PPD)

  Baseline ,one month and 3 months

• Clinical Attachment loss(CAL)

  Baseline ,one month and 3 months

• Mobility grade

  Baseline ,one month and 3 months

Study Arms (2)

test group

ACTIVE COMPARATOR

intra pocket diode laser application

Device: medency diode laser

control group

ACTIVE COMPARATOR

antibiotic adminstration

Drug: spirazole forte

Interventions

medency diode laser DEVICE

intra pocket application of diode laser

test group

spirazole forte DRUG

adminstration of spirazole forte with a dose 17 mg per kg

control group

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Amira Hafez

Alexandria, Egypt

Location

Related Publications (1)

• Anwar SK, Hafez AM, Roshdy YS. Clinical and microbiological efficacy of intra-pocket application of diode laser in grade C periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2024 Feb 23;24(1):270. doi: 10.1186/s12903-024-04031-0.

  PMID: 38395824 DERIVED

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at department of periodontolgy. Alexandria university

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 3, 2022
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

EG (1)