Periodontal PocketPhase 2/3NCT05222737
Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser
A Phase 2/3 study testing medency diode laser and spirazole forte in people with Periodontal Pocket, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- medency diode laser and spirazole forte
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
- 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
- Conditions
- Periodontal Pocket
- Being tested
- medency diode laser, spirazole forte
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medency diode laserDevice
intra pocket application of diode laser
spirazole forteDrug
adminstration of spirazole forte with a dose 17 mg per kg
| Study group | Role | What they receive |
|---|---|---|
| test group | Active comparator | intra pocket diode laser application Receives: Device: medency diode laser |
| control group | Active comparator | antibiotic adminstration Receives: Drug: spirazole forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2021
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amira hafez, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222737
- Sponsor's protocol ID
- lasers in periodontology
- Status last verified
- Jul 2022
- First submitted
- 25 Jan 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38395824
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05222737
- Acronym / sponsor ID
- lasers in periodontology
- Conditions
- Periodontal Pocket
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Active comparator | Device: medency diode laserintra pocket diode laser application |
| control group | Active comparator | Drug: spirazole forteantibiotic adminstration |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medency diode laserintra pocket application of diode laser | Device | test group |
| spirazole forteadminstration of spirazole forte with a dose 17 mg per kg | Drug | control group |
Primary outcome
Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria
Time frame: 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
1 secondary outcome
comparing levels of bacteria between test and control groups
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 38395824Anwar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing medency diode laser and spirazole forte in people with Periodontal Pocket, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05222737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.