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NCT Number: NCT07081230

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

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.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university Faculty of dentistry

Al Mansurah, Mansoura, 35516, Egypt

Location status: Recruiting

Location contact

HUSAIN A.JALIL ALAM, BDS

PRINCIPAL_INVESTIGATOR

husain a.jalil alam, BDS

CONTACT

[email protected]

+201500838200

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

ii) Inclusion Criteria:

  • Patients aging from 25-45 years
  • Patients with stage II /III periodontitis
  • Systemically free iii) 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

Treatment and study plan

SRP with hyaluronic acid

Combination Product

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

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

Primary outcomes

  1. Plaque index (PI)

    Time frame: baseline, 6weeks, 12weeks

    • Plaque index (PI):The index assigns a score to each tooth based on the amount of plaque present.

    0: No plaque is visible.

    • A thin film of plaque is present at the gingival margin (gumline) and can be detected with a probe.
    • Visible plaque along the gingival margin.
    • Heavy plaque accumulation in the gingival margin and interdental spaces.
  2. Bleeding on probing (BOP)

    Time frame: baseline, 6weeks, 12weeks

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

  3. Probing pocket Depth (PPD)

    Time frame: baseline, 6weeks, 12weeks

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

  4. Clinical Attachment Level (CAL)

    Time frame: baseline, 6weeks, 12weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

HUSAIN A.JALIL ALAM, BDS

CONTACT

[email protected]

+201500838200

Sponsors and collaborators

Lead sponsor

husain abduljalil alam

Other

Registry information

Official study title

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 (Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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