Clinical trial NCT05928546: Effect of Quercetin in Treatment of Periodontitis
Official title: Efficacy of Quercetin Nanoemulgel as Adjunct Local Delivery Drug in Non-surgical Treatment of Periodontitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Inflammation Gum
Keywords: Periodontitis
inflammation
Quarcetin
Nanoemulgel
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion 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 .

Primary outcomes:
measure: Evaluation of the changes in the clinical attachment loss
timeFrame: at base line, 1 month and 3 months after treatment
measure: Probing depth
timeFrame: at base line, 1 month and 3 months after treatment
measure: interferon IFN-γ analysis
timeFrame: at base line, 1 month and 3 months after treatment
measure: reactive oxygen species (ROS)
timeFrame: at base line, 1 month and 3 months after treatment
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: at base line, 1 month and 3 months after treatment
measure: Gingival index (GI)
timeFrame: at base line, 1 month and 3 months after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed Mortada Fikry, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.