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

NCT06401798 | Completed DMC

• 1 other identifier: KFSIRB200-189
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis Chronic Localized Slight

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

placebo control group

PLACEBO COMPARATOR

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

Drug: placebo gel

CWP group

ACTIVE COMPARATOR

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

Drug: CWP gel

NCWP group

ACTIVE COMPARATOR

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

Drug: NCWP gel

Interventions

placebo gel DRUG

Methylcellulose gel was applied topically to the pocket

Also known as: Methylcellulose gel

placebo control group

CWP gel DRUG

Methylcellulose gel combined with CWP was applied topically to the pocket

Also known as: Camel Whey Protein

CWP group

NCWP gel DRUG

Methylcellulose gel combined with NCWP was applied topically to the pocket

Also known as: Nano-Camel Whey Protein

NCWP group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

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

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

Study Officials

• Walid AH ELAMROUSY, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of periodontology

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: May 5, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)