Effect of plant extract for improvement in gum conditions

Not yet recruiting

Conditions: Other periodontal diseases,

Registration Number: CTRI/2022/10/046340

Lead Sponsor: Yuhan Care Co., Ltd.

Brief Summary: Periodontal diseases are diseases of the periodontium comprised of alveolar bone, the gingiva, periodontal ligament, and cement. Periodontal diseases are divided into gingivitis, which is localized to the gingiva, and periodontitis, which results from periodontal inflammation damaging periodontal ligaments and alveolar bone.

Bacteria are the main cause of periodontal diseases among many known causes. Hydrogen sulfide produced by anaerobic gram-negative bacteria around periodontal pockets and cytotoxins such as ammonia and amines directly damage periodontal tissues. LPS present on the cell walls of anaerobic gram-negative bacteria activate immune reactions, triggering the release of reactive oxygen species, and various cytokines such as prostaglandin, leukotriene, histamine, and interleukin that destroy periodontal tissues and induce inflammation. Enzymes from bacteria and white blood cells such as collagenase degrade collagen in periodontal tissues, causing a gingival recession that can lead to periodontal disease if left untreated. As such, antimicrobial and bacteriostatic actions, toxin removal, anti-inflammatory actions, and periodontal tissue restoration are the key to the prevention and treatment of periodontal diseases.

Surgical (scaling, root planning, subgingival curettage, and periodontal tissue regeneration) and non-surgical methods (pharmacotherapy) are used to treat periodontal diseases. While surgical methods are the most effective, they require patients visit to a clinic to receive treatment and are often performed after a disease has already progressed to a certain extent. For this reason, periodontal diseases often fail to be treated effectively and become chronic. Antibiotics prescribed in addition to treatment can cause side effects when delivered to untargeted sites in an excessive amount. A recent study reported isolating antibiotic-resistant bacteria from patients with periodontal diseases.

To overcome the limitations of surgical methods and antibiotic use and improve the prevention and treatment of periodontal diseases, drugs that can restore damaged or lost periodontal tissue must be developed. To develop a safe medication that can safely restore periodontal tissue, this study was conducted to examine various herbal medicines that can inhibit the activity of inflammatory cytokines and have intracellular activities related to bone resorption and formation. P.notoginseng, which showed excellent anti-inflammatory activity, and R.Radix P., which effectively inhibited bone resorption and promoted bone formation, were selected as candidate raw materials. Using these raw materials, YH23537, an active ingredient for periodontal dysfunction, was developed.

Major cytokines associated with bone loss, inflammation, and connective tissue damage caused by periodontal diseases include interleukin-1 (IL-1) and TNF-Î±). A study reported that blocking these cytokines in an animal model of periodontal disease inhibited connective tissue attachment and the loss of alveolar bone height). Activating monocyte-derived osteoclasts and macrophages within bone marrow promotes bone resorption, causing alveolar bone loss. Receptor activator of nuclear factor kappa-B ligand (RANKL) is essential for osteoclast-mediated bone resorption, and osteoprotegerin (OPG) produced by ligament cells, gingival fibroblasts, and epithelial cells inhibit the binding between RANKL and receptor activator of nuclear factor kappa-B (RANK), thereby inhibiting osteoclastogenesis.

Gingivitis is an inflammatory process limited to the mucosal epithelial tissue surrounding the cervical portion of the teeth and the alveolar processes. Gingivitis has been classified by clinical appearance (eg, ulcerative, hemorrhagic, necrotizing, purulent), etiology (eg, drug-induced, hormonal, nutritional, infectious, plaque-induced), and duration (acute, chronic). The most common type of gingivitis is a chronic form induced by plaque.

Gingivitis is generally regarded as a site-specific inflammatory condition initiated by dental biofilm accumulation and characterized by gingival redness and edema and the absence of periodontal attachment loss. Gingivitis is commonly painless, rarely leads to spontaneous bleeding, and is often characterized by subtle clinical changes, resulting in most patients being unaware of the disease or unable to recognize it.

Based on various previous in vitro and in vivo tests on, it is aimed to assess the safety and efficacy of YH23537 as an individually approved ingredient for gingival health at the optimal clinical dose and method of administration.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

1.Participants aged 20 â€“ 80 years old (both inclusive) 2.Those with a probing pocket depth of 3 to 5 mm.
Participants with more than 20 or more existing natural teeth 4.
Participants with symptoms of gingivitis or mild periodontitis 5.Participant with more than 10% BOP site and those who have at least one tooth with PD of more than 3mm and less than 5mm (inclusive of 5mm).
6.Participant with at least one site of bleeding while probing.
7.Participants who voluntarily agrees to participate and signs on informed consent form.

Exclusion Criteria

1.Participants who are allergic to the main ingredient of the investigational product.
2.Participants who smoked within 12 months prior the screening visit 3.Participant who has 5 or more teeth that need immediate dental caries treatment in the oral cavity.
4.Participants who have received prophylaxis and/or any other periodontal therapy within 6 months from the screening visit.
5.Participants who have received scaling within 1 month of the start of the study 6.Participants with bleeding control disease and being medicated with anticoagulant and/or antithrombotic agent 7.Those who show serious pathological findings in the soft tissues of the oral cavity 8.Patients with periodontitis requiring surgery or treatment such as tooth extraction 9.Those who have taken drugs that may affect periodontal condition (phenytoin, CCBs, cyclosporine, coumadin, NSAIDs, aspirin, etc.) for more than 5 consecutive days within the last 1 month 10.Those who have taken antibiotics, supplementary treatment for periodontal disease previous 1 month of screening visit.
11.Participants with uncontrolled diabetics, fasting glucose of more than 180mg/dL and is being medicated to treat diabetes 12.Participants with high blood pressure, more than 160/100mmHg 13.Participants with the history of cancer in past 5 years 14.Excessive alcohol consumption (> 20 g/day) 15.Participants with mental disorders such as schizophrenia, depression, drug addiction, alcoholism, etc.
16.Participants who are pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial 17.Those who have participated in another clinical trial previous 1 month of screening visit or plan to participate during the clinical trial period 18.Participants taking health functional food that affect gum health within 1 month prior to screening 19.Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigatorâ€™s opinion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	Baseline, week 4, week 8, and week 12

Secondary Outcome Measures

Name	Time	Method
Oral health related quality of life questionnaire	Baseline, week 12
Organoleptic Scoring Scale for Halitosis	Baseline, week 12
Gingival Index	Baseline, week 12
Plaque Index	Baseline, week 12
Bleeding on probing-at least in one site	Baseline, week 4, week 8, and week 12
IL-1beta, TNF-alpha in gingival fluid	Baseline, week 12

Trial Locations

Locations (1): Sparsh Super Speciality Hospital
🇮🇳
Bangalore, KARNATAKA, India
Sparsh Super Speciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Nanda Kishor K M
Principal investigator
9606197707
drnands@yahoo.co.in