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CompletedNCT05222737Updated Jul 6, 2022

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

A Phase 2/3 interventional study of medency diode laser and spirazole forte in Periodontal Pocket, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 15 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by Alexandria University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2021, registered Jan 2022).
Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
15 Years to 35 Years
Sex
All
01

Study 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
02

Conditions studied

  • Periodontal Pocket
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    test group

    intra pocket diode laser application

    Device: medency diode laser

  • Active comparator
    control group

    antibiotic adminstration

    Drug: spirazole forte

Interventions

  • Devicemedency diode laser

    intra pocket application of diode laser

  • Drugspirazole forte

    adminstration of spirazole forte with a dose 17 mg per kg

06

What researchers measure

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

    Time frame: baseline

Secondary outcomes

  1. 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.

    Time frame: baseline

Other outcomes

  1. Probing depth(PPD)

    Measure PPD at baseline and after treatment

    Time frame: Baseline ,one month and 3 months

  2. Clinical Attachment loss(CAL)

    Measure CAL at baseline and after treatment

    Time frame: Baseline ,one month and 3 months

  3. Mobility grade

    Measure mobility grade at baseline and after treatment

    Time frame: Baseline ,one month and 3 months

07

Study locations

1 site
  • Amira Hafez
    Alexandria, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05222737
Lead sponsor
Alexandria University
Responsible party
amira hafez (Resident at department of periodontolgy. Alexandria university, Alexandria University) — Principal investigator
First posted
Feb 3, 2022
Start date
Jan 1, 2021
Primary completion
Sep 1, 2021
Completion
Dec 1, 2021
Last update
Jul 6, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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