Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200415
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2023-12-28
Brief Title:
Glucosamine Sulphate Versus Ginger in Non-Surgical Periodontal Therapy
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Glucosamine Sulphate Versus Ginger as an Adjunctive Local Delivery Agents in Non-Surgical Periodontal Therapy A Randomized Controlled Clinical Trial With Biochemical Analysis
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glucosamine GlcN is an N-deacetyl amino monosaccharide sugar derived from complete hydrolysis of chitosan in which it is important vector for chondroitin and keratin sulfate while on the other hand medicinal plants became a source of great economic benefit worldwide ginger has been found to have biological activities such as antioxidant anti-inflammatory antimicrobial and anticancer activities So these effects which made it a good candidate to be used in periodontal therapy The main objective of this study is to assess and compare the effect of locally delivered glucosamine sulphate gel versus ginger gel on the clinical parameters in periodontitis patients including Plaque index PI Means sulcus bleeding index MSBI Probing depth PD Clinical attachment loss CAL and to detect the effect of locally delivered both gels on RANKL level in gingival crevicular fluid
Detailed Description:
Periodontitis was described as a chronic multifactorial inflammatory disease associated with formation of plaque biofilms and characterized by progressive destruction of the tooth-supporting apparatus Its primary manifestation includes the loss of periodontal tissue support featured through clinical attachment loss CAL and radiographically alveolar bone loss with the presence of periodontal pockets which are a significant mark of the disease hence can progressively lead to tooth loss and gingival bleeding
The new classification of periodontal and peri-implant diseases and conditions in 2017 classified these diseases into four main categories First category concerned with periodontal health gingival diseases either dental biofilm induced gingivitis or non-dental biofilm induced gingivitis Second category concerned with periodontitis which can be classified into necrotizing periodontitis periodontitis as a manifestation of systemic disease and periodontitis which include the forms of the disease previously recognized as chronic or aggressive Third category concerned with other conditions can affect the periodontium as systemic diseases traumatic occlusion mucogingival deformities tooth related factors periodontal abscesses and endodontic-periodontal diseases Fourth category concerned with peri-implant diseases and conditions as peri-implant health peri-implant mucositis peri-implantitis and peri-implant soft hard tissue deficiencies
But now Periodontitis can be described into four stages depending on the clinical attachment loss CAL starting from Stage 1 Initial periodontitis CAL 1-2 mm Stage 2 Moderate periodontitis CAL 3-4 mm Stage 3 Severe periodontitis with potential for additional tooth loss and Stage 4 Severe periodontitis with potential for loss of dentition CAL 5 mm Grading focuses on assessment of the risk factors as smoking systemic factors as diabetes and outcomes of non-surgical periodontal therapy Grade A Slow rate of progression no CAL loss over 5 years Grade B Moderate rate of progression CAL loss 2 mm over 5 years and Grade C Rapid rate of progression 2 mm over 5 years
The pathogenesis of periodontal diseases is mediated by the inflammatory response to bacteria in the dental biofilm The immune response to infection is regulated by cytokine and chemokine signals Cytokines and chemokines chemotactic cytokines are the messages between cells Cytokines are low-molecular-weight proteins involved in the initiation and advanced stages of inflammation in which they can regulate the amplitude and the duration of the response The genetic regulation leading to the secretion of proinflammatory cytokines from various cells is generally depending on the activation of nuclear factor kappa-B transcription Cytokines are produced by resident cells such as epithelial cells and fibroblasts and by phagocytes neutrophils and macrophages in the acute and early chronic phases of inflammation and by immune cells lymphocytes in early and advanced lesions After recognition of the presented microbes to the appropriate cells cytokines of the innate response including tumor necrosis factor alpha interleukin-1beta and interleukin-6 are the first to face in the pathogenesis pathways of the periodontal disease It is suggested that individuals who produce high levels of these mediators in response to such thing will go through more and severe tissue loss
In General periodontitis is a chronic inflammation in which elimination of the virulent factors can be necessary in treatment of periodontitis by initial intervention by scaling and root surface debridement So we should know about the importance of human gingival fibroblasts HGFs First HGFs represent most prominent cells in periodontal tissue Lipopolysaccharides LPS-treated HGFs produce inflammatory cytokines such as IL-6 and IL-8 and inflammatory chemical mediators such as Prostaglandin PGE2 and second HGFs continue to produce PGE2 IL-6 and IL-8 in the presence of LPS unlike macrophages So it is known that large number of chemical mediators and cytokines was obtained from HGFs can be within the periodontal tissues That kind of oral infection can be restricted by using antimicrobial mouth wash such as chlorhexidine usual handling of these chemicals may induce unwanted adverse effects such as tooth staining taste alteration and development of hypersensitivity reactions
Antibiotics such as penicillin have been notified for dental caries prevention in humans and animals merely they reported many side effects added to the development of the bacterial resistance so here comes the reason for a deep need for natural antibacterial substitutes One of the strongest substitutes are medicinal plants
Glucosamine is a biological element of joint cartilage it has been known as popular systemic supplement combined with chondroitin sulfate for knee osteoarthritis OA as so these compounds could have a chondro-protective effect on knee OA It is an amino monosaccharide in which it is important vector for chondroitin and keratin sulfate and also an independent meta-analysis has shown that in trials using a particular formulation of glucosamine as the crystalline glucosamine sulfate pCGS gives better result on pain than other preparations of glucosamine did Glucosamine has a role as a part of glucosaminoglycans GAGs it reveals an anti-inflammatory action in vitro and in vivo GlcN reduce the releasing of inflammatory mediators such as nitric oxide NO prostaglandin PG E2 and interleukin IL-8 by chondrocytes and synovial cells These outcomes propose that GlcN expresses an anti-inflammatory effect on chondrocytes and synovial cells hence revealing a protective action on OA Chondroitin-sulphate CS and glycosamine-sulphate GS has proved a direct effect on OA in combination or alone as CS has a direct effect on suppressing the production of osteoprotegerin OPG and RANKL the main two major factors involved in the remodeling process and GS especially has a significant effect In vitro studies have shown that glucosamine prevents bone resorption by means of down-regulation of RANKL expression in the joints through lowering the number of RANKL positive T cells and the level of sRANKL in the joints extracts
On the other hand medicinal plants became a source of great economic benefit worldwide The recent natural recipes utilizing medicinal plants is giving a natural replacement for antibiotic unpleasant effects such as supra infections hypersensitivity reaction and teeth staining In addition using of systemic antibiotics against oral infections is not recommended because of the risk for development of bacterial resistance However the discovery of natural extracts of medicinal plants with antimicrobial and anti-inflammatory activity will be valuable and safe
Ginger Zingiber officinale Roscoe which belongs to the Zingiberaceae family and the Zingiber genus has been commonly consumed as a spice and an herbal medicine for a long time Bioactive compounds such as terpene and phenolic compounds have been recognized in ginger The phenolic compounds are mainly gingerols shogaol and paradols they resemble for different bioactivities of ginger Ginger has been found to have biological activities such as antioxidant anti-inflammatory antimicrobial and anticancer activities A lot of studies have revealed that ginger can affect many diseases such as cardiovascular diseases neurodegenerative diseases obesity diabetes mellitus chemotherapy-induced nausea and emesis and respiratory disorders So more attention will be focused on the bioactivities of the ginger
In fresh ginger the major polyphenols are gingerols such as 6-gingerol 8-gingerol and 10-gingerol Which if heat treated or stored for long time turns into into corresponding shogaol and after hydrogenation shogaol can be transformed into paradols It was found that overproduction of free radicals such as reactive oxygen species ROS plays a strong role in the initiation of many chronic diseases
Antioxidant activity studies have shown that ginger has a protective effect against reactive oxygen species ROS as it showed antioxidant effects in the chondrocyte cells of human with oxidative stress mediated by interleukin-1β IL-1β It lowers the production of ROS and lipid peroxidation and stimulates the expression of several antioxidant enzymes Ginger and its bioactive compounds such as 6-shogaol exerting an antioxidant role via the nuclear factor erythroid 2-related factor 2 Nrf2 signaling pathway
Anti-Inflammatory Activity several studies has conveyed that ginger and its active compounds has anti-inflammatory activity which can protect against inflammation-related diseases The anti-inflammatory effects were mostly related to phosphatidylinositiol -3-kinase PI3K protein kinase B Akt and the nuclear factor kappa light chain-enhancer of activated B cells NF-κB Adding that 6-shogaol exhibited a protective impact against tumor necrosis factor α TNF-α It also down regulates the Claudin-2 and the disassembly of Claudin-1 via the suppression of signaling pathways involved with PI3KAkt and NF-κB Moreover nanoparticles derived from edible ginger GDNPs 2 could increase the levels of anti-inflammatory cytokines such as interleukin-10 IL-10 and IL-22 and decreasing the levels of pro-inflammatory cytokines such as TNF-α IL-6 and IL-1β specifically nanoparticles loaded with 6-shogaol so help in lowering the inflammatory process
Cytotoxicity Ginger has been examined and considered for its anticancer properties against different types of cancers such as breast cervical prostate and colorectal cancer Where its mechanisms of action are represented in the inhibition of proliferation and the induction of apoptosis in cancer cells
Antidiabetic Activity Diabetes mellitus is known as a serious metabolic disorder condition caused by insulin deficiency andor insulin resistance which results in an abnormal rising in blood glucose Prolonged hyperglycemia could speed up the protein glycation production which results in formation of advanced glycation end products AGEs An in vitro study resulted in both 6-shogaol and 6-gingerol preventing the progression of diabetic complications and how they prevent the production of AGEs by trapping methyl-glyoxal MGO the precursor of AGEs Other several studies have investigated the antidiabetic effect of ginger and its major active elements
The new classification of periodontal and peri-implant diseases and conditions in 2017 classified these diseases into four main categories First category concerned with periodontal health gingival diseases either dental biofilm induced gingivitis or non-dental biofilm induced gingivitis Second category concerned with periodontitis which can be classified into necrotizing periodontitis periodontitis as a manifestation of systemic disease and periodontitis which include the forms of the disease previously recognized as chronic or aggressive Third category concerned with other conditions can affect the periodontium as systemic diseases traumatic occlusion mucogingival deformities tooth related factors periodontal abscesses and endodontic-periodontal diseases Fourth category concerned with peri-implant diseases and conditions as peri-implant health peri-implant mucositis peri-implantitis and peri-implant soft hard tissue deficiencies
But now Periodontitis can be described into four stages depending on the clinical attachment loss CAL starting from Stage 1 Initial periodontitis CAL 1-2 mm Stage 2 Moderate periodontitis CAL 3-4 mm Stage 3 Severe periodontitis with potential for additional tooth loss and Stage 4 Severe periodontitis with potential for loss of dentition CAL 5 mm Grading focuses on assessment of the risk factors as smoking systemic factors as diabetes and outcomes of non-surgical periodontal therapy Grade A Slow rate of progression no CAL loss over 5 years Grade B Moderate rate of progression CAL loss 2 mm over 5 years and Grade C Rapid rate of progression 2 mm over 5 years
The pathogenesis of periodontal diseases is mediated by the inflammatory response to bacteria in the dental biofilm The immune response to infection is regulated by cytokine and chemokine signals Cytokines and chemokines chemotactic cytokines are the messages between cells Cytokines are low-molecular-weight proteins involved in the initiation and advanced stages of inflammation in which they can regulate the amplitude and the duration of the response The genetic regulation leading to the secretion of proinflammatory cytokines from various cells is generally depending on the activation of nuclear factor kappa-B transcription Cytokines are produced by resident cells such as epithelial cells and fibroblasts and by phagocytes neutrophils and macrophages in the acute and early chronic phases of inflammation and by immune cells lymphocytes in early and advanced lesions After recognition of the presented microbes to the appropriate cells cytokines of the innate response including tumor necrosis factor alpha interleukin-1beta and interleukin-6 are the first to face in the pathogenesis pathways of the periodontal disease It is suggested that individuals who produce high levels of these mediators in response to such thing will go through more and severe tissue loss
In General periodontitis is a chronic inflammation in which elimination of the virulent factors can be necessary in treatment of periodontitis by initial intervention by scaling and root surface debridement So we should know about the importance of human gingival fibroblasts HGFs First HGFs represent most prominent cells in periodontal tissue Lipopolysaccharides LPS-treated HGFs produce inflammatory cytokines such as IL-6 and IL-8 and inflammatory chemical mediators such as Prostaglandin PGE2 and second HGFs continue to produce PGE2 IL-6 and IL-8 in the presence of LPS unlike macrophages So it is known that large number of chemical mediators and cytokines was obtained from HGFs can be within the periodontal tissues That kind of oral infection can be restricted by using antimicrobial mouth wash such as chlorhexidine usual handling of these chemicals may induce unwanted adverse effects such as tooth staining taste alteration and development of hypersensitivity reactions
Antibiotics such as penicillin have been notified for dental caries prevention in humans and animals merely they reported many side effects added to the development of the bacterial resistance so here comes the reason for a deep need for natural antibacterial substitutes One of the strongest substitutes are medicinal plants
Glucosamine is a biological element of joint cartilage it has been known as popular systemic supplement combined with chondroitin sulfate for knee osteoarthritis OA as so these compounds could have a chondro-protective effect on knee OA It is an amino monosaccharide in which it is important vector for chondroitin and keratin sulfate and also an independent meta-analysis has shown that in trials using a particular formulation of glucosamine as the crystalline glucosamine sulfate pCGS gives better result on pain than other preparations of glucosamine did Glucosamine has a role as a part of glucosaminoglycans GAGs it reveals an anti-inflammatory action in vitro and in vivo GlcN reduce the releasing of inflammatory mediators such as nitric oxide NO prostaglandin PG E2 and interleukin IL-8 by chondrocytes and synovial cells These outcomes propose that GlcN expresses an anti-inflammatory effect on chondrocytes and synovial cells hence revealing a protective action on OA Chondroitin-sulphate CS and glycosamine-sulphate GS has proved a direct effect on OA in combination or alone as CS has a direct effect on suppressing the production of osteoprotegerin OPG and RANKL the main two major factors involved in the remodeling process and GS especially has a significant effect In vitro studies have shown that glucosamine prevents bone resorption by means of down-regulation of RANKL expression in the joints through lowering the number of RANKL positive T cells and the level of sRANKL in the joints extracts
On the other hand medicinal plants became a source of great economic benefit worldwide The recent natural recipes utilizing medicinal plants is giving a natural replacement for antibiotic unpleasant effects such as supra infections hypersensitivity reaction and teeth staining In addition using of systemic antibiotics against oral infections is not recommended because of the risk for development of bacterial resistance However the discovery of natural extracts of medicinal plants with antimicrobial and anti-inflammatory activity will be valuable and safe
Ginger Zingiber officinale Roscoe which belongs to the Zingiberaceae family and the Zingiber genus has been commonly consumed as a spice and an herbal medicine for a long time Bioactive compounds such as terpene and phenolic compounds have been recognized in ginger The phenolic compounds are mainly gingerols shogaol and paradols they resemble for different bioactivities of ginger Ginger has been found to have biological activities such as antioxidant anti-inflammatory antimicrobial and anticancer activities A lot of studies have revealed that ginger can affect many diseases such as cardiovascular diseases neurodegenerative diseases obesity diabetes mellitus chemotherapy-induced nausea and emesis and respiratory disorders So more attention will be focused on the bioactivities of the ginger
In fresh ginger the major polyphenols are gingerols such as 6-gingerol 8-gingerol and 10-gingerol Which if heat treated or stored for long time turns into into corresponding shogaol and after hydrogenation shogaol can be transformed into paradols It was found that overproduction of free radicals such as reactive oxygen species ROS plays a strong role in the initiation of many chronic diseases
Antioxidant activity studies have shown that ginger has a protective effect against reactive oxygen species ROS as it showed antioxidant effects in the chondrocyte cells of human with oxidative stress mediated by interleukin-1β IL-1β It lowers the production of ROS and lipid peroxidation and stimulates the expression of several antioxidant enzymes Ginger and its bioactive compounds such as 6-shogaol exerting an antioxidant role via the nuclear factor erythroid 2-related factor 2 Nrf2 signaling pathway
Anti-Inflammatory Activity several studies has conveyed that ginger and its active compounds has anti-inflammatory activity which can protect against inflammation-related diseases The anti-inflammatory effects were mostly related to phosphatidylinositiol -3-kinase PI3K protein kinase B Akt and the nuclear factor kappa light chain-enhancer of activated B cells NF-κB Adding that 6-shogaol exhibited a protective impact against tumor necrosis factor α TNF-α It also down regulates the Claudin-2 and the disassembly of Claudin-1 via the suppression of signaling pathways involved with PI3KAkt and NF-κB Moreover nanoparticles derived from edible ginger GDNPs 2 could increase the levels of anti-inflammatory cytokines such as interleukin-10 IL-10 and IL-22 and decreasing the levels of pro-inflammatory cytokines such as TNF-α IL-6 and IL-1β specifically nanoparticles loaded with 6-shogaol so help in lowering the inflammatory process
Cytotoxicity Ginger has been examined and considered for its anticancer properties against different types of cancers such as breast cervical prostate and colorectal cancer Where its mechanisms of action are represented in the inhibition of proliferation and the induction of apoptosis in cancer cells
Antidiabetic Activity Diabetes mellitus is known as a serious metabolic disorder condition caused by insulin deficiency andor insulin resistance which results in an abnormal rising in blood glucose Prolonged hyperglycemia could speed up the protein glycation production which results in formation of advanced glycation end products AGEs An in vitro study resulted in both 6-shogaol and 6-gingerol preventing the progression of diabetic complications and how they prevent the production of AGEs by trapping methyl-glyoxal MGO the precursor of AGEs Other several studies have investigated the antidiabetic effect of ginger and its major active elements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None