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Effect of Quercetin in Treatment of Periodontitis

Primary Purpose

Inflammation Gum

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Quercetin
scaling and root planing
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation Gum focused on measuring Periodontitis, inflammation, Quarcetin, Nanoemulgel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Group(I):scaling and root planing only

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

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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

    Secondary Outcome Measures

    Plaque index (PI)
    It used to assess plaque accumulation around gingival margin. The degree of plaque accumulation was recorded as follow: 0= No plaque around the gingival margin. 1= A thin film of plaque around the gingival margin. The plaque may be recognized only by running a probe across the tooth surface. 2= Moderate accumulation of soft deposits on the gingival margin and/or adjacent tooth surface, which can be seen by naked eye. 3= Abundance plaque accumulation within the gingival pocket and/or on the gingival margin and adjacent tooth surface and hard deposits on the tooth surface are seen.
    Gingival index (GI)
    It used to assess gingival inflammation. The degree of gingival inflammation was recorded as follow: 0 = Normal gingiva. 1 = Mild inflammation, slight change in color, slight edema and no bleeding on probing. 2= Moderate inflammation, redness, edema and bleeding on probing. 3= Severe inflammation, marked redness, edema and tendency to spontaneous bleeding.

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    October 6, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05928546
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    November 20, 2023 (Anticipated)
    Study Completion Date
    November 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation Gum
    Keywords
    Periodontitis, inflammation, Quarcetin, Nanoemulgel

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group(I):scaling and root planing only
    Arm Type
    Placebo Comparator
    Arm Description
    10 sites will receive non-surgical periodontal therapy (scaling and root planing) .
    Arm Title
    Group(Ⅱ):scaling and root planing with application of quercetin nanoemulgel
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Quercetin
    Intervention Description
    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
    Device
    Intervention Name(s)
    scaling and root planing
    Intervention Description
    - 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.
    Primary Outcome Measure Information:
    Title
    Evaluation of the changes in the clinical attachment loss
    Description
    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.
    Time Frame
    at base line, 1 month and 3 months after treatment
    Title
    Probing depth
    Description
    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.
    Time Frame
    at base line, 1 month and 3 months after treatment
    Title
    interferon IFN-γ analysis
    Description
    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.
    Time Frame
    at base line, 1 month and 3 months after treatment
    Title
    reactive oxygen species (ROS)
    Description
    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
    Time Frame
    at base line, 1 month and 3 months after treatment
    Secondary Outcome Measure Information:
    Title
    Plaque index (PI)
    Description
    It used to assess plaque accumulation around gingival margin. The degree of plaque accumulation was recorded as follow: 0= No plaque around the gingival margin. 1= A thin film of plaque around the gingival margin. The plaque may be recognized only by running a probe across the tooth surface. 2= Moderate accumulation of soft deposits on the gingival margin and/or adjacent tooth surface, which can be seen by naked eye. 3= Abundance plaque accumulation within the gingival pocket and/or on the gingival margin and adjacent tooth surface and hard deposits on the tooth surface are seen.
    Time Frame
    at base line, 1 month and 3 months after treatment
    Title
    Gingival index (GI)
    Description
    It used to assess gingival inflammation. The degree of gingival inflammation was recorded as follow: 0 = Normal gingiva. 1 = Mild inflammation, slight change in color, slight edema and no bleeding on probing. 2= Moderate inflammation, redness, edema and bleeding on probing. 3= Severe inflammation, marked redness, edema and tendency to spontaneous bleeding.
    Time Frame
    at base line, 1 month and 3 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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 .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alzahraa Ahmed Alghriany, lecturer
    Phone
    +201203770058
    Email
    alghriany@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Mortada, professor
    Phone
    +201005432223
    Email
    mortadafikry@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Mortada Fikry, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21093559
    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.
    Results Reference
    background
    PubMed Identifier
    26558438
    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.
    Results Reference
    background
    PubMed Identifier
    34408403
    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.
    Results Reference
    background
    PubMed Identifier
    15979867
    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.
    Results Reference
    background

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    Effect of Quercetin in Treatment of Periodontitis

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