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

NCT ID: NCT07081230

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2025-11-01

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.

Detailed Description

III. Treatment Procedures:

Three weeks prior to treatment all patients will receive phase I periodontal therapy in the form of non-surgical mechanical debridement using ultrasonic and hand instruments, oral hygiene instructions will be demonstrated to all patients.

Group I (Test group 1): will receive mechanical debridement and injection of hyaluronic acid mixed with growth factor concentrates in the periodontal pocket, the growth factor concentrates will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,two to four milliliters of the initial portion of plasma PPP (platelet-poor plasma) is then collected with a syringe and discarded, leaving the other blood portions, the LPCGF (liquid phase concentrated growth factors) from buffy coat is collected then it will be mixed using a female-female connector with hyaluronic acid and injected into the pocket.

Group II (Test group 2) : will receive mechanical debridement and ALB-PRF will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,Two to four milliliters of the initial portion of plasma (platelet-poor plasma) is then collected with a syringe and placed into a heating device , while the other blood portions (buffy coat, LPCGF, and red blood cells) are placed in a cooling storage bag. The syringes containing PPP are then inserted into a heating device for human serum albumin denaturation plasma to produce the albumin gel. After 10 minutes at an operating temperature of 75°C, the syringes are then removed and allowed to cool in a cooling storage bag and protected from ambient light. The LPCGF (liquid phase concentrated growth factors) from buffy coat are then collected. Thereafter, the albumin gel and the liquid-CGF are mixed between syringes by passing back and forth (roughly 10×) using a female-female connector to create ALB-PRF which is ready to be injected in the periodontal pocket, ALB-PRF gel will be injected into periodontal pocket by special needle until it is full.

Group III (Control group): will receive mechanical debridement only. All patients will be advised not to eat hard food, they were also advised not to brush the area for 12h or to floss or use interproximal cleaning devices for ten days. During the study period, the patients were instructed to continue regular tooth brushing and interdental cleansing, also instructed not to use any mouth washes for the Duration of the study.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HYALURONIC ACID MIX WITH CGF

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

Group Type: EXPERIMENTAL

SRP with hyaluronic acid

Intervention Type: COMBINATION_PRODUCT

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

ALB PRF

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

Group Type: EXPERIMENTAL

SRP + Injectable Platelet-Rich Fibrin

Intervention Type: COMBINATION_PRODUCT

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

Interventions

SRP with hyaluronic acid

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

Intervention Type: COMBINATION_PRODUCT

SRP + Injectable Platelet-Rich Fibrin

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

husain abduljalil alam

OTHER

Sponsor Role: lead

Responsible Party

husain abduljalil alam

Principal Investigator,BDS, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mansoura university Faculty of dentistry

Al Mansurah, Mansoura, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

HUSAIN A.JALIL ALAM, BDS

Role: CONTACT

hussainalam@std.mans.edu.eg

+201500838200

Facility Contacts

husain a.jalil alam, BDS

Role: primary

hussainalam@std.mans.edu.eg

+201500838200

Other Identifiers

A03010250M

Identifier Type: -

Identifier Source: org_study_id