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Use of QLC gel as an antibacterial agent in treatment of patients with gum disease.

Formulation, physicochemical characterization and clinical evaluation of therapeutic potential of quercetin loaded chitosan nanoparticles in management of chronic periodontitis - Nill

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086237
Enrollment
45
Registered
2025-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K053- Chronic periodontitis

Interventions

Intervention1: 0.1% Quercetin Chitosan Nanoparticle Gel: Local drug delivery in Periodontal Pocket for 7 days Control Intervention1: Placebo Gel: Local drug delivery in Periodontal Pocket for 7 days

Sponsors

Nikesh Narayana Moolya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Systemically healthy subjects with a minimum of 20 teeth. Subjects with moderate chronic periodontitis and no other gingival lesions. Subjects between the age group 35 to 60 years. No removable prosthesis or orthodontic bands or appliances worn at the time of study.

Exclusion criteria

Exclusion criteria: Subjects with a history of any antibiotics, anti-inflammatory or antimicrobial mouth rinse usage or periodontal therapy in the preceding 3 months or during the study period. Subjects with suspected allergy to any flavanoids, chitin based products, those on anticoagulant or steroid therapy, smokers, tobacco chewers, alcoholics, pregnant or lactating mothers. Immunocompromised patients, dental infections like chronic periapical lesions, apthous stomatitis, oral lichen planus, non-compliant or physically challenged patients.

Design outcomes

Primary

MeasureTime frame
1. Plaque Index (PI) (Silness J, Loe H,1964) 2. Gingival Index (GI) (Loe H, Silness J,1963) 3. Modified Sulcus Bleeding Index (SBI) (Mombelli 1987) 4. Probing Pocket Depth (PPD) (measured from crest of the gingival margin to the base of the pocket) and 5. Relative Clinical Attachment Levels (CAL) (measured from the lower border of acrylic stent to the base of the pocket) to be recorded only for the selected sites by using a customized acrylic stent. (with UNC-15 probe)Timepoint: Baseline and Postoperatively 45 days

Secondary

MeasureTime frame
Collection of Unstimulated Whole Saliva(UWS) samples UWS to be collected at approximately the same time of day by the drooling method (Rhodus et al., 2005). Briefly, subjects asked to refrain from eating or drinking for 2 hours prior to saliva collection. At least 2ml of UWS to be collected by passively drooling into a chilled centrifuge tube for 5-10 minutes. The tubes to be codified and transferred on ice to the laboratory for processing. All samples to be centrifuged and the supernatant constituting clarified saliva to be separated and stored until further analysis. Unstimulated whole saliva (UWS) sampling to be conducted to evaluate IL-1L1 beta levels and samples will be sent to Department of Biotechnology and Bioinformatics for processing and analysis Timepoint: Baseline and Postoperatively 45 days

Countries

India

Contacts

Public ContactNIKESH NARAYAN A MOOLYA

SMBT Dental College and Hospital Sangamner

drpsrakhewar@gmail.com9370017343

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026