NCT06982248

Brief Summary

the proposed study aims to investigate the effect of Quercetin in treatment of periodontitis patients

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

December 11, 2024

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment clinical attachment level by UNC 15 periodontal probe

    12 weeks

Secondary Outcomes (1)

  • assessment of the gingival crevicular levels of NF-κB by Elisa kit

    12 weeks

Study Arms (4)

Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin

EXPERIMENTAL

selected patients receive SRP and chitosan nanoparticles gel loaded by quercetin

Drug: NSP and chitosan nanoparticles gel loaded by quercetin

Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel.

EXPERIMENTAL

selected patients receive SRP and chitosan nanoparticles gel

Drug: NSP and chitosan nanoparticles gel

Group 3: Periodontitis patients treated by NSPT only

ACTIVE COMPARATOR

NSPT

Procedure: scaling and root planning

Group 4: Periodontally healthy subjects.

NO INTERVENTION

healthy individual act as control group

Interventions

NSP and chitosan nanoparticles gel loaded by quercetin

Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin

NSP and chitosan nanoparticles gel

Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel.

NSPT

Group 3: Periodontitis patients treated by NSPT only

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients of both sexes with an age ranging between 25 and 55 years will be included in the study. Patients diagnosed as having periodontitis based on clinical and radiographic examinations will be included

You may not qualify if:

  • Insulin dependent diabetes
  • Thyroid disease
  • Patients with sensitivity to the medication used in the study
  • patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study will be excluded from the study.
  • Additionally, patients with systemic diseases, smokers, pregnant and lactating patients, and patients not compliant with oral hygiene procedures will also be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Aga, Egypt

Location

MeSH Terms

Conditions

Periodontal Pocket

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Jilan mohamed

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Group 1: Periodontitis patients treated by NSPT and chitosan nanoparticles gel loaded by quercetin. Group 2: Periodontitis patients treated by NSPT and chitosan nanoparticles gel. Group 3: Periodontitis patients treated by NSPT only. Group 4: Periodontally healthy subjects.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

May 21, 2025

Study Start

August 15, 2024

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations