Effect of Quercetin in Treatment of Periodontitis

NCT05928546 | Unknown Phase 1

• 1 other identifier: Quercetin in periodontitis
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontitis is an immune-inflammatory disease affecting the supporting structures of the teeth. It is a disease of multifactorial etiology, with microbial, genetic, environmental and host factors involved, with the release of oxygen-free radicals by the inflammatory cells. Quercetin, have shown potential antimicrobial activity, lowering of inflammatory markers, cholesterol reduction and inhibiting bone loss. However, this data has largely been obtained from in vitro and animal studies, but data from human studies are limited.

Conditions

Inflammation Gum

Keywords

Periodontitis; inflammation; Quarcetin; Nanoemulgel

Outcome Measures

Primary Outcomes (4)

• Evaluation of the changes in the clinical attachment loss

  Attachment level was measured using UNC15(University of North Carolina) periodontal probe. Clinical attachment loss was measured as the distance from the cemento-enamel junction to the base of the pocket.

  at base line, 1 month and 3 months after treatment

• Probing depth

  The measurement were recorded by UNC15(University of North Carolina) periodontal probe . Pocket depth was measured as the distances from the free gingival margin to the base of the periodontal pocket.

  at base line, 1 month and 3 months after treatment

• interferon IFN-γ analysis

  The samples were assayed for (IFN-γ) levels using commercially available enzyme-linked immune-sorbent assay (ELISA) . Highly sensitive ELISA kit was used to detect the (IFN-γ) level in pg/ml in the sample of GCF according to the manufacturer's instructions.

  at base line, 1 month and 3 months after treatment

• reactive oxygen species (ROS)

  The samples were assayed for antioxidant effect of quercetin using commercially available reactive oxygen species( ROS) kit . Highly sensitive ROS kit was used according to the manufacturer's instruction

  at base line, 1 month and 3 months after treatment

Secondary Outcomes (2)

• Plaque index (PI)

  at base line, 1 month and 3 months after treatment

• Gingival index (GI)

  at base line, 1 month and 3 months after treatment

Study Arms (2)

Group(I):scaling and root planing only

PLACEBO COMPARATOR

10 sites will receive non-surgical periodontal therapy (scaling and root planing) .

Device: scaling and root planing

Group(Ⅱ):scaling and root planing with application of quercetin nanoemulgel

ACTIVE COMPARATOR

10 sites will receive non-surgical periodontal therapy followed by the application of quercetin nanoemulgel local delivery 2 times one at the day of non-surgical periodontal therapy and after 2 weeks.

Drug: Quercetin; Device: scaling and root planing

Interventions

Quercetin DRUG

Intra-pocket application of quercetin nanoemulgel : * After conventional periodontal treatment, the teeth were isolated by cotton rolls for intra pocket application of the gel. * That gel was injected in periodontal pocket using syringe with blunt cannula till the gel excess exit from the pocket .

Group(Ⅱ):scaling and root planing with application of quercetin nanoemulgel

scaling and root planing DEVICE

\- Full-mouth scaling and root planing was performed in 1-2 sessions within 2 weeks using manual scalers and curettes or ultrasonic scaler and local anesthesia was used in case of need for patient comfort.

Group(I):scaling and root planing only; Group(Ⅱ):scaling and root planing with application of quercetin nanoemulgel

Eligibility Criteria

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

You may qualify if:

• Patients with periodontitis stage ( Ⅰ \& Ⅱ ). Stage I have CAL 1 to 2mm with no tooth loss and probing depth ≤4 mm. Stage II have CAL 3 to 4mm with no tooth loss and probing depth ≤5 mm..
• Patients who have teeth with both mesial and distal neighboring teeth .
• Patient with more than 20 natural teeth .
• Patient free from any systemic disease that may effect the periodontal status according to the criteria of Cornell Medical Index and its modification.

You may not qualify if:

• Long-term therapy with medications within a month prior to enrollment that could affect periodontal status or healing.
• Pregnant woman and lactating mothers .
• Patients with a history of traumatic occlusion.
• Teeth with both endo-perio lesion .
• Patients with previous periodontal treatment including scaling and root planing and periodontal surgery in the last 3 and 6 months, respectively .

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Gao L, Liu G, Wang X, Liu F, Xu Y, Ma J. Preparation of a chemically stable quercetin formulation using nanosuspension technology. Int J Pharm. 2011 Feb 14;404(1-2):231-7. doi: 10.1016/j.ijpharm.2010.11.009. Epub 2010 Nov 17.

  PMID: 21093559 BACKGROUND

• Gomez-Florit M, Monjo M, Ramis JM. Quercitrin for periodontal regeneration: effects on human gingival fibroblasts and mesenchymal stem cells. Sci Rep. 2015 Nov 12;5:16593. doi: 10.1038/srep16593.

  PMID: 26558438 BACKGROUND

• Wei Y, Fu J, Wu W, Ma P, Ren L, Yi Z, Wu J. Quercetin Prevents Oxidative Stress-Induced Injury of Periodontal Ligament Cells and Alveolar Bone Loss in Periodontitis. Drug Des Devel Ther. 2021 Aug 12;15:3509-3522. doi: 10.2147/DDDT.S315249. eCollection 2021.

  PMID: 34408403 BACKGROUND

• Kantarci A, Van Dyke TE. Lipoxin signaling in neutrophils and their role in periodontal disease. Prostaglandins Leukot Essent Fatty Acids. 2005 Sep-Oct;73(3-4):289-99. doi: 10.1016/j.plefa.2005.05.019.

  PMID: 15979867 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Periodontitis; Inflammation

Interventions

Quercetin; Weights and Measures; Root Planing

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Investigative Techniques; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Ahmed Mortada Fikry, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alzahraa Ahmed Alghriany, lecturer

CONTACT

+201203770058; alghriany@aun.edu.eg

Ahmed Mortada, professor

CONTACT

+201005432223; mortadafikry@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry

Model Details: Group(I): 10 sites will receive non-surgical periodontal therapy (scaling and root planing) . Group(Ⅱ): 10 sites will receive non-surgical periodontal therapy followed by the application of quercetin nanoemulgel local delivery 2 times one at the day of non-surgical periodontal therapy and after 2 weeks.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 3, 2023
• Study Start: February 20, 2024
• Primary Completion: May 20, 2024
• Study Completion: May 30, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share