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临床试验/NCT06936592
NCT06936592尚未招募不适用

How Can Prefabricated Membrane-loaded Ascorbic Acid Curtail the Gingival Recession?

Minia University0 个研究点目标入组 30 人开始时间: 2025年4月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Gingival recession height

研究概览

简要总结

Periodontal diseases are a prevalent issue, often leading to gingival recession, where the gingival margin recedes, exposing the tooth root and causing various problems. Gingival recession can be managed through both non-surgical and surgical interventions The non-surgical approach often involves plaque control and addressing any underlying inflammatory conditions. However, in cases of advanced recession, surgical treatment may be necessary Several treatment techniques have been proposed, which can be divided into pedicle and free grafts. The latter can also be classified as free gingival grafts (FGG) or as connective tissue grafts (CTG). Other treatment options include soft tissue substitutes or regenerative therapies Harvesting graft from the palate has several problems, such as pain, inflammation, bleeding, flap necrosis, and infection at the donor site. For this reason, we need a substitute for soft tissue graft harvesting Carbopol polymers, also known as carbomers, are widely utilized in pharmaceutical formulations for their excellent mucoadhesive properties. This high molecular weight, cross-linked acrylic acid polymers are particularly effective in enhancing the adhesion of formulations to mucosal surfaces, thereby improving drug delivery and bioavailability

详细描述

Gingival recession is a common finding in daily clinical practice. Several issues may be associated with the apical shift of the gingival margin such as dentine hypersensitivity, root caries, non-carious cervical lesions (NCCLs), and compromised aesthetics. The first step in an effective management and prevention program is to identify susceptibility factors and modifiable conditions associated with gingival recession. Non-surgical treatment options for gingival recession defects include establishing optimal plaque control, removing overhanging subgingival restorations, behavior change interventions, and using desensitizing agents. In cases where a surgical approach is indicated, coronally advanced flap and tunneling procedures combined with a connective tissue graft are considered the most predictable treatment options for single and multiple recession defects. If there is a contraindication for harvesting a connective tissue graft from the palate or the patient wants to avoid a donor site surgery, adjunctive use of acellular dermal matrices, collagen matrices, and/or enamel matrix derivatives can be a valuable treatment alternative. For gingival recession defects associated with NCCLs a combined restorative-surgical approach can provide favourable clinical outcomes. If a patient refuses a surgical intervention or there are other contraindications for an invasive approach, gingival conditions should be maintained with preventive measures. This paper gives a concise review of when and how to treat gingival recession defects.

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, Outcomes Assessor)

盲法说明

participants do not know the type of membrane and the outcomes assessor does not know type of group

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients of both genders with ages more than 18 years.
  • •At least two adjacent teeth in maxillary or mandibular anterior sextant with Cairo classification (RT1 or RT 2) labial GR defect.
  • •Good general health with no contraindications for periodontal surgery (American Society of Anesthesiologists I).
  • •Non-smoker patients.

排除标准

  • •Pregnant and lactating women.
  • •Teeth exhibiting pathologic mobility.
  • •Mal alignment teeth.
  • •Patients under active orthodontic therapy.
  • •Periodontal therapy during the last 6 months.
  • •Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.

研究组 & 干预措施

study group

Active Comparator

Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with membrane loaded by Ascorbic acid

干预措施: Ascorbic acid (Drug)

control group

Placebo Comparator

Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with a placebo membrane

干预措施: Ascorbic acid (Drug)

结局指标

主要结局

Gingival recession height

时间窗: baseline, 3months and 6 months

The distance from the cementoenamel junction to the gingival margin

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

shaimaa hamdy

lecturer of periodontology

Minia University

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