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

Radiographic and Clinical Assessment of Locally Delivered Camel Whey Protein Gel and Camel Whey Protein Nanoparticles Gel in Stage II Grade B Periodontitis: Randomized Controlled Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis Chronic Localized Slight
• Intervention / Treatment: Drug: placebo gel; Drug: CWP gel; Drug: NCWP gel

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 214312
      • oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo control group; After proper scaling and root planning, placebo gel will be applied topically to the affected sites.	Drug: placebo gel; Methylcellulose gel was applied topically to the pocket; Other Names: Methylcellulose gel
Active Comparator: CWP group; Topical application of CWP gel will be applied topically to the affected sites.	Drug: CWP gel; Methylcellulose gel combined with CWP was applied topically to the pocket; Other Names: Camel Whey Protein
Active Comparator: NCWP group; CWP nanoparticles gel will be applied topically to the affected sites.	Drug: NCWP gel; Methylcellulose gel combined with NCWP was applied topically to the pocket; Other Names: Nano-Camel Whey Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone height:	This incorporated the measurement of the bone defect height from the cemento-enamel junction (CEJ) to the base of the defect BD, the level of the alveolar crest from CEJ to the alveolar crest (AC), the bone defect depth from AC to BD). A line perpendicular was drawn from the AC to the root surface, and the intersection point across the root surface was considered as AC. The distance from the point AC to the base of the defect (AC-BD) will be considered as the intraosseous defect depth.	6-months
Mesiodistal (MD) and buccolingual (BL) bone defect width	The distance from the point AC to the alveolar crest (AC) will be considered as the MD width of the intraosseous defect. The BL width will be measured in the axial plane as the horizontal distance between the most coronal point for the buccal and lingual alveolar crest. A slice thickness of 0.2 mm will be used for CBCT analysis	6-months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Walid AH ELAMROUSY, PhD, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: KFSIRB200-189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No