跳至主要内容
临床试验/NCT07081230
NCT07081230招募中不适用

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)

husain abduljalil alam1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Plaque index (PI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Randomization will be performed before starting the study by computer generated tables to allocate each patient in his group.

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

HYALURONIC ACID MIX WITH CGF

Experimental

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

干预措施: SRP with hyaluronic acid (Combination Product)

ALB PRF

Experimental

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

干预措施: SRP + Injectable Platelet-Rich Fibrin (Combination Product)

结局指标

主要结局

Plaque index (PI)

时间窗: baseline, 6weeks, 12weeks

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.

Clinical Attachment Level (CAL)

时间窗: baseline, 6weeks, 12weeks

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

Bleeding on probing (BOP)

时间窗: baseline, 6weeks, 12weeks

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

Probing pocket Depth (PPD)

时间窗: baseline, 6weeks, 12weeks

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

次要结局

未报告次要终点

研究者

发起方
husain abduljalil alam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

husain abduljalil alam

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

Mansoura University

研究点 (1)

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