Stage II and III PeriodontitisNCT07892261
Effectiveness of Topical Fluoroquinolone Gel in Treating Stage II/III Periodontitis
A study testing Levofloxacin in-situ gel and Professional mechanical plaque removal in people with Stage II and III Periodontitis, run by Naira Mohammed at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate the effect of local application of levofloxacin gel on healing of periodontal pockets in patients with stage II/III periodontitis. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stage II and III Periodontitis
- What is being tested?
- Levofloxacin in-situ gel and Professional mechanical plaque removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2024to 4 Oct 2025
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age limit of 30-65 years of both the genders.
- Probing pocket depth (PPD) of ≥5mm (stage II/III) bilaterally.
- Systemically healthy subjects.
- No history of periodontal therapy within 6 months prior to the study.
Who cannot join
- 1. Chronic use of antibiotics/ anti- inflammatory drugs 3 months prior to the study 2. Routine use of mouthwash or other plaque controlling agents 3. Diabetic patients or other immunocompromised patients 4. Any form of tobacco users, alcohol users. 5. Known history of allergy to drugs 6. Pregnant and lactating women. 7. Pathologic migration / tooth under traumatic occlusion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate
About this study
Official title: Effectiveness of Topically Applied Fluoroquinolone Gel in the Management of Stage II/III Periodontitis (A Randomized, Controlled Clinical Trial)
The goal of this clinical trial is to investigate the effect of local application of levofloxacin gel on healing of periodontal pockets in patients with stage II/III periodontitis. The main questions it aims to answer are:
- Is there a difference difference between topical application of Fluoroquinolone gel (levofloxacin) in management of Stage II/III periodontitis in non-surgical treatment of periodontal pockets and professional mechanical plaque removal (PMPR)?
- Does the in-situ gel show better clinical periodontal health parameters?
Read more
Researchers will compare topically applied levofloxacin gel to conventional professional mechanical plaque removal (PMPR) to assess if levofloxacin gel is effective in treating stage II and III periodontitis.
Participants will:
- Undergo professional mechanical plaque removal (PMPR) then will be injected with the in-situ gel in selected pockets.
- Be given strict oral hygiene instructions to follow at home after the application of gel.
- Come back for reapplication of the gel a week later.
- Visit the clinic at selected follow-up periods: after 1 month, 3 months, and 6 months.
- Conditions
- Stage II and III Periodontitis
- Being tested
- Levofloxacin in-situ gel, Professional mechanical plaque removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin in-situ gelDrug
Topically applied levofloxacin in-situ gel in selected pockets of patients with stage II and III periodontitis
Professional mechanical plaque removalProcedure or surgery
Thorough mechanical debridement of pockets and gingival structure
| Study group | Role | What they receive |
|---|---|---|
| With gel | Experimental | PMPR then application of levofloxacin in-situ gel in pockets of patients with stage II and III periodontitis and follow-up at 1 month, 3 months, and 6 months. Receives: Drug: Levofloxacin in-situ gel; Procedure: Professional mechanical plaque removal |
| Without gel | Active comparator | PMPR only then follow-up at 1 month, 3 months, and 6 months. Receives: Procedure: Professional mechanical plaque removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
To assess changes in probing depth using William's probe, measuring it from the base of the pocket up to the gingival margin. A decrease in probing depth readings indicates improved clinical outcomes.
Measured: Up to 6 months.
Clinical Attachment Loss
To assess changes in clinical attachment loss using William's probe, measured from the base of the pocket up to the gingival margin, then the distance between cemento-enamel junction to the gingival margin is measured. The second measurement is then deducted from the first one to calculate clinical attachment loss. During follow-up, a decrease in this figure represents gain in attachment, hence healing.
Measured: Up to 6 months
Modified Gingival Index
Using a scale from 0 to 4, visual assessment is used to grade the gingival index, with a score of 0 representing normal gingiva, up to a score of 4 representing the most inflammed tissue.
Measured: Up to 6 months
Bleeding Index
A scale from 0 to 3 is used to grade bleeding index. Using a probe, you gently pass along the gingival margin to check the presence and grade of bleeding. 0 represents no bleeding, 3 represents profuse bleeding in the intended area.
Measured: Up to 6 months
O'leary Plaque Index
It's graded by a scale ranging from 0 to 3, with 0 representing no plaque and 3 representing heavy plaque seen by the naked eye. William's probe is used to gently move in a brushing motion along the gingival margin to detect any plaque.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start3 Aug 2024
- Primary completion19 Aug 2025
- Study completion4 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II and III PeriodontitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naira Mohammed
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Naira Mohammed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892261
- Sponsor's protocol ID
- 9242996
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Topically Applied Fluoroquinolone Gel in the Management of Stage II/III Periodontitis (A Randomized, Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07892261
- Acronym / sponsor ID
- 9242996
- Conditions
- Stage II and III Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Naira MohammedUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 4 Oct 2025 (actual)
- First posted
- 23 Oct 2026 (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.
The goal of this clinical trial is to investigate the effect of local application of levofloxacin gel on healing of periodontal pockets in patients with stage II/III periodontitis. The main questions it aims to answer are:
- Is there a difference difference between topical application of Fluoroquinolone gel (levofloxacin) in management of Stage II/III periodontitis in non-surgical treatment of periodontal pockets and professional mechanical plaque removal (PMPR)?
- Does the in-situ gel show better clinical periodontal health parameters?
Researchers will compare topically applied levofloxacin gel to conventional professional mechanical plaque removal (PMPR) to assess if levofloxacin gel is effective in treating stage II and III periodontitis.
Participants will:
- Undergo professional mechanical plaque removal (PMPR) then will be injected with the in-situ gel in selected pockets.
- Be given strict oral hygiene instructions to follow at home after the application of gel.
- Come back for reapplication of the gel a week later.
- Visit the clinic at selected follow-up periods: after 1 month, 3 months, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With gel | Experimental | Drug: Levofloxacin in-situ gel, Procedure: Professional mechanical plaque removalPMPR then application of levofloxacin in-situ gel in pockets of patients with stage II and III periodontitis and follow-up at 1 month, 3 months, and 6 months. |
| Without gel | Active comparator | Procedure: Professional mechanical plaque removalPMPR only then follow-up at 1 month, 3 months, and 6 months. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age limit of 30-65 years of both the genders.
- Probing pocket depth (PPD) of ≥5mm (stage II/III) bilaterally.
- Systemically healthy subjects.
- No history of periodontal therapy within 6 months prior to the study.
Key exclusion criteria (1 listed)
- 1. Chronic use of antibiotics/ anti- inflammatory drugs 3 months prior to the study 2. Routine use of mouthwash or other plaque controlling agents 3. Diabetic patients or other immunocompromised patients 4. Any form of tobacco users, alcohol users. 5. Known history of allergy to drugs 6. Pregnant and lactating women. 7. Pathologic migration / tooth under traumatic occlusion.
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 |
|---|---|---|
| Levofloxacin in-situ gelTopically applied levofloxacin in-situ gel in selected pockets of patients with stage II and III periodontitis | Drug | With gel |
| Professional mechanical plaque removalThorough mechanical debridement of pockets and gingival structure | Procedure or surgery | With gel, Without gel |
Primary outcome
Probing depth
Time frame: Up to 6 months.
To assess changes in probing depth using William's probe, measuring it from the base of the pocket up to the gingival margin. A decrease in probing depth readings indicates improved clinical outcomes.
Clinical Attachment Loss
Time frame: Up to 6 months
To assess changes in clinical attachment loss using William's probe, measured from the base of the pocket up to the gingival margin, then the distance between cemento-enamel junction to the gingival margin is measured. The second measurement is then deducted from the first one to calculate clinical attachment loss. During follow-up, a decrease in this figure represents gain in attachment, hence healing.
Modified Gingival Index
Time frame: Up to 6 months
Using a scale from 0 to 4, visual assessment is used to grade the gingival index, with a score of 0 representing normal gingiva, up to a score of 4 representing the most inflammed tissue.
Bleeding Index
Time frame: Up to 6 months
A scale from 0 to 3 is used to grade bleeding index. Using a probe, you gently pass along the gingival margin to check the presence and grade of bleeding. 0 represents no bleeding, 3 represents profuse bleeding in the intended area.
O'leary Plaque Index
Time frame: Up to 6 months
It's graded by a scale ranging from 0 to 3, with 0 representing no plaque and 3 representing heavy plaque seen by the naked eye. William's probe is used to gently move in a brushing motion along the gingival margin to detect any plaque.
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 study testing Levofloxacin in-situ gel and Professional mechanical plaque removal in people with Stage II and III Periodontitis, run by Naira Mohammed 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 4 inclusion and 1 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 27 Oct 2026. 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.
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?
Probing depth (time frame: Up to 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.