Efficacy of Camel Whey Protein and Camel Whey Protein Nanoparticles for Treating Intra-bony Periodontal Defects

NCT07358104 | Active Not Recruiting DMC

• 1 other identifier: KFSIRB200-317
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Intraosseous bone defects (IOBDs) are a significant challenge in the treatment of periodontal disease. Several bone graft materials can be used for bone defect regeneration. Camel whey protein (CWP) has emerged as a promising alternative due to its unique properties, including: High biological value containing essential amino acids, anti-inflammatory, antioxidant and immunomodulatory effects. However, the therapeutic application of CWP for bone regeneration can be limited by its solubility and bioavailability . Nanoparticles offer a novel approach to enhance drug delivery and improve therapeutic efficacy. Introduction of bone grafts in the form of nanoparticles was found to improve the bioactivity and biocompatibility of artificial bone graft. Nanoparticles (NPs) can efficiently enter biological organisms due to their very tiny size. The ability of NPs to easily pass through even the smallest blood capillaries and escape being phagocytized due to their small size (1-100 nm) extends their plasma half-life and permits a more progressive release of the medication. Nanoparticles have quicker absorption and a relatively greater drug loading arise from interactions at the surface. NPs increased antibacterial action may be attributed to their huge surface area and high charge density, which allows them to interact with the negatively charged surface of bacterial cells

Conditions

Periodontal Diseases; Periodontal Attachment Loss

Outcome Measures

Primary Outcomes (1)

• bone fill

  Radiographic bone fill will be assessed using CBCT by subtracting the preoperative and postoperative x-rays, followed by measuring the resultant bone volume in mm³.

  6-months

Secondary Outcomes (3)

• bone density

  6-months

• Clinical probing pocket depths

  6-months

• clinical attachment level

  6-months

Study Arms (4)

Open currettage

EXPERIMENTAL

open flap debridement

Drug: only open flap debridement

Open curettage with scaffold material

PLACEBO COMPARATOR

scaffold material

Drug: scaffold material

Open curettage with Camel whey protein

ACTIVE COMPARATOR

CWP

Drug: CWP

Open curettage with Camel whey protein nanoparticle

ACTIVE COMPARATOR

CWP NPs

Drug: CWP NPs

Interventions

only open flap debridement DRUG

only open flap granulation tissue debridement

Open currettage

scaffold material DRUG

open flap debridement with defect filling with scaffold material

Open curettage with scaffold material

CWP DRUG

open flap debridement with defect filling with CWP

Open curettage with Camel whey protein

CWP NPs DRUG

open flap debridement with defect filling with CWP NPs

Open curettage with Camel whey protein nanoparticle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The patient age range will be 18-45 years of both sexes Stage III or IV periodontitis (probing depth ≥ 6 mm in teeth and clinical attachment ≥ 5 mm).
• Clinical and radiographic confirmation of 3 wall intrabony defects.
• Absence of any complicating systemic condition that may contraindicate surgical procedures.
• Adequate oral hygiene.
• Eligible participants should present good general health and agree to random assignment to any of the parallel study groups.

You may not qualify if:

• Allergy
• Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, uncooperative individuals or those unable to attend the study follow-up appointments.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participant , investigator and outcome assessors are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and postgrad course director of Periodontology Department Faculty of Oral and Dental Medicine,Kafrelsheikh University

Model Details: healthy patients with Stage III or IV periodontitis will be selected from the outpatient clinic of the Department of Periodontology, sulcular incisions will be performed followed by elevation of mucoperiosteal flaps and granulation tissue curettage then various interventions will be applied to each group

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 22, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): August 4, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

EG (1)