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.
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
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.
- Conditions
- Periodontitis Chronic Localized Slight
- 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 group | Role | What they receive |
|---|---|---|
| placebo control group | Placebo comparator | After proper scaling and root planning, placebo gel will be applied topically to the affected sites. Receives: Drug: placebo gel |
| CWP group | Active comparator | Topical application of CWP gel will be applied topically to the affected sites. Receives: Drug: CWP gel |
| NCWP group | Active comparator | CWP 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.
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
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.
- First posted7 May 2024
- Study start5 May 2024
- Primary completion1 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Chronic Localized SlightStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
- Investigators
- Walid AH ELAMROUSY, PhD, Principal investigator, Kafrelsheikh University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06401798
- Acronym / sponsor ID
- KFSIRB200-189
- Conditions
- Periodontitis Chronic Localized Slight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo control group | Placebo comparator | Drug: placebo gelAfter proper scaling and root planning, placebo gel will be applied topically to the affected sites. |
| CWP group | Active comparator | Drug: CWP gelTopical application of CWP gel will be applied topically to the affected sites. |
| NCWP group | Active comparator | Drug: NCWP gelCWP nanoparticles gel will be applied topically to the affected sites. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo gelAlso: Methylcellulose gelMethylcellulose gel was applied topically to the pocket | Drug | placebo control group |
| CWP gelAlso: Camel Whey ProteinMethylcellulose gel combined with CWP was applied topically to the pocket | Drug | CWP group |
| NCWP gelAlso: Nano-Camel Whey ProteinMethylcellulose gel combined with NCWP was applied topically to the pocket | Drug | NCWP group |
Primary outcome
Bone height:
Time frame: 6-months
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.
Mesiodistal (MD) and buccolingual (BL) bone defect width
Time frame: 6-months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walid AH ELAMROUSY, PhD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
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.