Locally Delivered Whey Protein Nanoparticles Gel in Stage II Grade B Periodontitis

NCT ID: NCT06401798

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-05
• Study Completion Date: 2025-03-15

Brief Summary

Aim of the current study is to evaluate radiographic and clinical alterations following topical application of CWP gel and CWP nanoparticles gel in stage II grade B periodontitis patients.

Detailed Description

Periodontal disease is an oral inflammatory process that is typically initiated by bacterial infection stimulating the host response to produce various inflammatory mediators in high levels, which are also involved in the initiation and progression of periodontal disease.Such mediators generate a cascade reaction that eventually leads to the irreversible degradation of connective tissues and bone, with subsequent loss of periodontal attachment.

A new periodontitis classification scheme has been adopted, in which forms of the disease previously recognized as "chronic" or "aggressive" are now grouped under a single category ("periodontitis") and are further characterized based on a multi-dimensional staging and grading system. Staging is largely dependent upon the severity of disease at presentation as well as on the complexity of disease management, while grading provides supplemental information about biological features of the disease including a history-based analysis of the rate of periodontitis progression; assessment of the risk for further progression; analysis of possible poor outcomes of treatment; and assessment of the risk that the disease or its treatment may negatively affect the general health of the patient. periodontitis is classified using a system of staging and grading:

Staging reflects the severity and extent of disease based on tissue destruction:

• Stage I: Interdental CAL 1-2 mm, no tooth loss due to periodontitis, maximum probing depth ≤4 mm with horizontal bone loss mostly.
• Stage II: Interdental CAL 3-4mm, no tooth loss due to periodontitis, maximum probing depth ≤5mm with horizontal bone loss mostly.
• Stage III: Interdental CAL ≥5 mm, tooth loss due to periodontitis of ≤4 dents, maximum probing depth ≥ 6 mm and mostly associated with vertical bone loss.
• Stage IV: Interdental CAL ≥5 mm, tooth loss due to periodontitis of ≥5 dents and maximum probing depth ≥ 6 mm.

Grading of periodontitis refers to how quickly the disease is progressing.

• Grade A (Slow): Bone loss is progressing slowly.
• Grade B (Moderate): Bone loss is progressing at a moderate rate.
• Grade C (Rapid): Bone loss is progressing rapidly. The ultimate goal of periodontal therapy is to prevent further disease progression in order to reduce the risk of tooth loss and to restore the tissues that have been lost as a result of periodontitis. (4) The gold-standard treatment for periodontitis is subgingival debridement associated with effective supragingival biofilm control. However, even though mechanical debridement presents favorable short-term results, these benefits may not be maintained in the long-term, especially in susceptible individuals who develop a chronic (hyper)inflammatory response against the microbiome that is associated with genetic, systemic, or environmental factors. Failure of periodontal therapy stems largely from an inability to re-verse biofilm dysbiosis and to control inflammation. Therefore, antimicrobial agents and immune modulators have been considered for the treatment of periodontitis.

The additional use of antibiotics, systemically in the treatment of periodontitis is limited, due to the need for high doses to achieve the appropriate concentration of the drug in the gingival fluid, rapidly growing resistance of the bacteria, and side effects of the drugs. In addition, due to the advanced organization of the structure and function of the subgingival biofilm, antibiotics may not be effective or can be inactivated. Therefore, for almost 30 years, drug systems (antibiotics, antiseptics anti-inflamatories and anti-oxidants) have been developed in the form of direct subgingival administration. The advantage of this form of treatment is the significant concentration of the drug after application and its persistence for up to several weeks. With this form of application, many side effects that are associated with general systemic therapy can be avoided.

Camel whey protein (CWP) has a potent natural antioxidative effect as it reduces the oxidative stress and strengthens the immune system functions. The beneficial effects of CWP dietary supplementation include the stimulation of adaptive and innate immunity and anti-inflammatory, antibacterial, anticancer, antiviral, and antioxidative effects In addition, it has been shown that CWP improves the treatment of impaired wound healing in diabetic patients. Studies have demonstrated the consequences of supplementary CWP on the reduction of inflammatory biomarkers, proinflammatory cytokines, modulation of the immune functions, and free radicals' reactive oxygen species. Those effects of CWP could play a potential role in treating periodontitis.

Local delivery of nanoparticles emerges as a promising strategy for improved treatment. These nanoparticles, due to their minute size and tailorable properties, offer targeted drug delivery to the periodontal pocket. This approach concentrates therapeutic effects at the infection site, potentially enhancing treatment efficacy while minimizing systemic side effects of conventional medications.

Due to technical developments and the availability of cone-beam computed tomography (CBCT), 3-D imaging has become feasible and offers some advantages and potential for the evaluation of complex anatomical structures. CBCT illustrates and validates the possibility of radiographically visualizing and metrically assessing hard and soft periodontal tissues.

No previous researches have examined the outcomes of CWP on the treatment of periodontitis. Consequently, the current study was designed to assess the effects of topical CWP gel and CWP nanoparticle gel as an adjunct to nonsurgical therapy versus nonsurgical therapy alone on the clinical as well as radiographic parameters of stage II grade B periodontitis patients.

Conditions

Periodontitis Chronic Localized Slight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo control group

After proper scaling and root planning, placebo gel will be applied topically to the affected sites.

Group Type: PLACEBO_COMPARATOR

placebo gel

Intervention Type: DRUG

Methylcellulose gel was applied topically to the pocket

CWP group

Topical application of CWP gel will be applied topically to the affected sites.

Group Type: ACTIVE_COMPARATOR

CWP gel

Intervention Type: DRUG

Methylcellulose gel combined with CWP was applied topically to the pocket

NCWP group

CWP nanoparticles gel will be applied topically to the affected sites.

Group Type: ACTIVE_COMPARATOR

NCWP gel

Intervention Type: DRUG

Methylcellulose gel combined with NCWP was applied topically to the pocket

Interventions

placebo gel

Methylcellulose gel was applied topically to the pocket

Intervention Type: DRUG

CWP gel

Methylcellulose gel combined with CWP was applied topically to the pocket

Intervention Type: DRUG

NCWP gel

Methylcellulose gel combined with NCWP was applied topically to the pocket

Intervention Type: DRUG

Other Intervention Names

Methylcellulose gel; Camel Whey Protein; Nano-Camel Whey Protein

Eligibility Criteria

Inclusion Criteria

• patients will be selected to be systemically free with stage II periodontitis
• having 3-4 mm interdental clinical attachment loss (CAL) at ≥2 nonadjacent teeth
• maximum probing depth ≤5 mm

Exclusion Criteria

• smokers
• pregnant and lactating females
• patients received any type of periodontal treatment in the past 6 months prior to examination
• patients who used antibiotic or anti-inflammatory drugs or antioxidants within the 6 months preceding the beginning of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Walid Elamrousy

Assistant Professor of periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walid AH ELAMROUSY, PhD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-189

Identifier Type: -

Identifier Source: org_study_id