Effect of Quercetin in Treatment of Periodontitis

NCT ID: NCT05928546

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-05-30

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.

Detailed Description

Quercetin has been found to decrease the extracellular matrix degradation, promote wound healing when tested in gingival fibroblasts, and showed excellent antibacterial properties. It also possesses antioxidant effect which can be explored to restrict the inflammation in periodontitis. Despite the beneficial effects of Quercetin, its poor aqueous solubility and poor bioavailability result in limited absorption, so scientists have worked on improving the bioavailability of Quercetin using various approaches, such as nanosuspension , self-nano emulsifying systems , microemulsion , solid lipid nanoparticles and cyclodextrin complexes. The combination of oils and emulsifiers enhances the absorption of Quercetin. Hence, nanoemulsion could be a suitable drug delivery vehicle for the loading of Quercetin. Nanoemulsions are more beneficial than microemulsions, as they have high kinetic stability and a smaller droplet size. Therefore, the present study will investigate the efficacy of nanoemulgel of quercetin as adjunct to conventional therapy in treatment of periodontitis.

Conditions

Inflammation Gum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group(I):scaling and root planing only

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

Group Type: PLACEBO_COMPARATOR

scaling and root planing

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

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.

Group Type: ACTIVE_COMPARATOR

Quercetin

Intervention Type: 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 .

scaling and root planing

Intervention Type: 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.

Interventions

Quercetin

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 .

Intervention Type: DRUG

scaling and root planing

\- 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Alzahraa Alghriany

Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Mortada Fikry, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Alzahraa Ahmed Alghriany, lecturer

Role: CONTACT

alghriany@aun.edu.eg

+201203770058

Ahmed Mortada, professor

Role: CONTACT

mortadafikry@hotmail.com

+201005432223

References

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.

Reference Type: BACKGROUND

PMID: 21093559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26558438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34408403 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15979867 (View on PubMed)

Other Identifiers

Quercetin in periodontitis

Identifier Type: -

Identifier Source: org_study_id