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Periodontitis Chronic Localized SlightNCT06401798

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

A study testing CWP gel and NCWP gel in people with Periodontitis Chronic Localized Slight, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis Chronic Localized Slight
What is being tested?
CWP gel and NCWP gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteEgypt
Study dates
5 May 2024to 15 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University

    Kafr ash Shaykh, Kafrelsheikh, 214312

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
placebo gel, CWP gel, NCWP gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placebo gelDrug

    Also called Methylcellulose gel

    Methylcellulose gel was applied topically to the pocket

  • CWP gelDrug

    Also called Camel Whey Protein

    Methylcellulose gel combined with CWP was applied topically to the pocket

  • NCWP gelDrug

    Also called Nano-Camel Whey Protein

    Methylcellulose gel combined with NCWP was applied topically to the pocket

Study groups in NCT06401798
Study groupRoleWhat they receive
placebo control groupPlacebo comparatorAfter proper scaling and root planning, placebo gel will be applied topically to the affected sites.
Receives: Drug: placebo gel
CWP groupActive comparatorTopical application of CWP gel will be applied topically to the affected sites.
Receives: Drug: CWP gel
NCWP groupActive comparatorCWP nanoparticles gel will be applied topically to the affected sites.
Receives: Drug: NCWP gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6-months

  2. 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

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start5 May 2024
  3. Primary completion1 Mar 2025
  4. Study completion15 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401798
Sponsor's protocol ID
KFSIRB200-189
Status last verified
Apr 2025
First submitted
2 May 2024
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CWP gel and NCWP gel in people with Periodontitis Chronic Localized Slight, run by Kafrelsheikh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone height: (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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