Comparison Between the Efficacy of Albumin Versus Hyaluronic Acid Scaffold in Combination With Concentrated Growth Factors as an Adjunct to Non-surgical Treatment of Periodontitis

NCT07081230 | Recruiting

• 1 other identifier: A03010250M
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to clinically evaluate the efficacy of albumin versus hyaluronic acid scaffolds in combination with concentrated growth factors in the non- surgical treatment of stage II/III periodontitis. The secondary objective is to evaluate the duration and concentration of different growth factors release in the gingival crevicular fluid.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (4)

• Plaque index (PI)

  1\. Plaque index (PI):The index assigns a score to each tooth based on the amount of plaque present. 0: No plaque is visible. 1. A thin film of plaque is present at the gingival margin (gumline) and can be detected with a probe. 2. Visible plaque along the gingival margin. 3. Heavy plaque accumulation in the gingival margin and interdental spaces.

  baseline, 6weeks, 12weeks

• Bleeding on probing (BOP)

  "0" if no bleeding occurred within 10 second, and "1" if there was bleeding within 10 second.

  baseline, 6weeks, 12weeks

• Probing pocket Depth (PPD)

  will be measured from the gingival margin to the base of the periodontal pocket

  baseline, 6weeks, 12weeks

• Clinical Attachment Level (CAL)

  will be measured from the cement-enamel junction to the base of the periodontal pocket

  baseline, 6weeks, 12weeks

Study Arms (2)

HYALURONIC ACID MIX WITH CGF

EXPERIMENTAL

patients will receive hyaluronic acid mixed with concentrated growth factors after mechanical debridement

Combination Product: SRP with hyaluronic acid

ALB PRF

EXPERIMENTAL

patients will receive Albumin gel mixed with concentrated growth factors after mechanical debridement

Combination Product: SRP + Injectable Platelet-Rich Fibrin

Interventions

SRP with hyaluronic acid COMBINATION_PRODUCT

patients will receive hyaluronic acid mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement

HYALURONIC ACID MIX WITH CGF

SRP + Injectable Platelet-Rich Fibrin COMBINATION_PRODUCT

patients will receive Albumin gel mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement

ALB PRF

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aging from 25-45 years
• Patients with stage II /III periodontitis

You may not qualify if:

• Any systemic condition that may impact the study (21)
• Poor oral hygiene
• Pregnant and breastfeeding women
• Smoking patients.
• Patients received periodontal treatment in the last 6 months
• Unable to comply with study protocol

Sponsors & Collaborators

• husain abduljalil alam: lead

Study Sites (1)

Mansoura university Faculty of dentistry

Al Mansurah, Mansoura, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

HUSAIN A.JALIL ALAM, BDS

CONTACT

+201500838200; hussainalam@std.mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization will be performed before starting the study by computer generated tables to allocate each patient in his group.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator,BDS, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,

Model Details: Patients will be randomly divided into 3 groups with (10) patients each. Group I (Test group 1): patients will receive hyaluronic acid mixed with concentrated growth factors after mechanical debridement. Group II (Test group 2): patients will receive Albumin gel mixed with concentrated growth factors after mechanical debridement. Group III (Control group): patients will receive mechanical debridement only.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 23, 2025
• Study Start: July 7, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

EG (1)