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临床试验/NCT06153706
NCT06153706已完成2 期

Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis (A Randomized Controlled Clinical Trial)

Yasmeen Khaled1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Bleeding on probing

研究概览

简要总结

This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from stage II periodontitis with probing depth and exhibiting bleeding on probing.
  • Patients showing good oral hygiene.
  • No history of periodontal therapy (surgical and non-surgical) for the past 6 months.

排除标准

  • Patients with known systemic and debilitating diseases.
  • Patients who had any previous adverse reactions to the products (or similar products) used in this study.
  • Patients who have any autoimmune diseases.
  • Patients who have any known disease that interfere with periodontal procedure.
  • Pregnancy and lactating women.
  • Use of antibiotics during the last 6 months.

研究组 & 干预措施

L-PFR

Active Comparator

干预措施: Subgingival application of L-PRF (Other)

L-PFR loaded with medical grade metronidazole

Experimental

干预措施: Subgingival application of L-PRF loaded with metronidazole (Drug)

结局指标

主要结局

Bleeding on probing

时间窗: up to 6 months

This was assessed using bleeding index which assesses bleeding on probing. The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. The score ranges from 0% (no bleeding) to 100% (bleeding in all sites)

Probing depth

时间窗: up to 6 months

The distance measured (mm) using a periodontal probe from the base of the pocket to the most apical point on the gingival margin. It dictates the patient's ability to maintain optimal plaque control. Probing depths in excess of 3mm are an indication for periodontal therapy.

Clinical attachment loss

时间窗: up to 6 months

It represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance (mm) from the cemento-enamel junction to the base of the pocket

Plaque accumulation

时间窗: up to 6 months

This was assessed using O'Leary plaque index which is based on the visible continuous plaque along the gingival margin after staining. Four or six sites per tooth were examined, and the percentage of tooth surfaces exhibiting stained plaque was calculated. The score ranges from 0% (no plaque) to 100% (abundant plaque)

Gingival inflammation

时间窗: up to 6 months

This was assessed using modified gingival index which uses a visual scale to assess gingival health. It relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. Using this index, 108 sites are scored per person (52 papillary and 56 marginal sites). Score 0 indicates normal gingival, score 1: mild inflammation with slight changes in color and texture, but not in all portions of gingival marginal or papillary, score 2: Mild inflammation with slight changes in color and texture in all portions of gingival marginal or papillary, score 3: Moderate bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary, and score 4: Severe inflammation with erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration

Quantitative assessment of Porhyromonas gingivalis

时间窗: up to 6 months

Relative quantitation of Porhyromonas gingivalis counts was performed by Real Time PCR. Subgingival plaque samples were calculated, DNA was isolated and quantified for standardizing the polymerase chain reaction.

次要结局

未报告次要终点

研究者

发起方
Yasmeen Khaled
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasmeen Khaled

Periodontology Masters degree candidate

Alexandria University

研究点 (1)

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