Effectiveness of Topical Fluoroquinolone Gel in Treating Stage II/III Periodontitis: A Randomized Controlled Trial

NCT07892261 | Completed

• 1 other identifier: 9242996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Up to 6 months

Study Arms (2)

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.

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.

Procedure: Professional mechanical plaque removal

Interventions

Levofloxacin in-situ gel DRUG

Topically applied levofloxacin in-situ gel in selected pockets of patients with stage II and III periodontitis

With gel

Professional mechanical plaque removal PROCEDURE

Thorough mechanical debridement of pockets and gingival structure

With gel; Without gel

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Naira Mohammed: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc candidate in periodontology

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: August 3, 2024
• Primary Completion: August 19, 2025
• Study Completion: October 4, 2025
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

EG (1)