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临床试验/CTRI/2025/05/087904
CTRI/2025/05/087904招募中2 期

Comparative evaluation of recession coverage with modified coronally advanced flap and deepithelialized gingival graft using microsurgical and conventional approach: A split mouth randomized clinical trial.

A Ajaisha1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年6月10日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
16
试验地点
1
主要终点
Mean root coverage

研究概览

简要总结

The displacement of the gingival margin apical to the cementoenamel junction is known as gingival recession or marginal soft tissue recession. Though tooth loss rarely occurs as a result of it, consequences such as root sensitivity, tooth decay, abrasion, and aesthetics have always been of great concern.Improper tooth brushing, periodontal disease, malaligned teeth, alveolar bone dehiscence, thin gingival biotype of gingiva covering a nonvascularized surface of the root, abnormal attachment of muscle, and occlusal trauma are some of the etiological factors that are linked to its occurrence.

For root coverage, many different types of surgical procedures have been proposed, such as lateral displaced flaps, coronally positioned flaps (CPF), connective tissue grafts, and other combination techniques. The use of coronally advanced flaps (CAF) for adequate root coverage is strongly supported by the literature. De Sanctis and Zucchelli modified the coronally advanced flap technique by elevating split- full- split thickness flap with oblique releasing incisions. This technique was successful in attaining complete root coverage, and the clinical outcomes sustained over a three-year period.

Due to its high predictability and capacity to enhance the width and thickness of keratinized tissue, connective tissue graft is regarded as the gold standard. Due to limited donor tissues, bigger dimension of CTG is needed. This is one of the limitations of CTG. To overcome the limitations of CTG, de-epithelialized gingival graft (DGG), was invented by Zucchelli and coworkers. It is harvested as a free gingival graft and then extra- orally de-epithelialized. Using this method, palatal harvesting is possible irrespective of fibromucosa thickness. In comparison to SCTG, connective tissue generated via the DGG method is thought to be more stable and to consist of less fatty and glandular tissue. Research has demonstrated the efficiency of CAF + DGG in achieving root coverage.

The aim of periodontal plastic surgery is to develop less invasive techniques that favor rapid healing, less postoperative discomfort, and higher patient satisfaction, in addition to providing satisfactory results of root covering based on clinical observations. Because the surgical microscope provides adequate illumination and magnification of the operating field, it has been employed to achieve these goals. These developments may enable more accurate and less traumatic tissue manipulation, allowing for healing by first intention and exact coadaptation of wound margins.

Studies have conclusively shown that when compared to conventional or macrosurgical approaches, periodontal plastic surgical treatments planned for root coverage and done under a surgical microscope improved the treatment outcomes at a clinically significant level.

Considering all the above factors, the aim of this present split mouth randomized clinical trial is to compare the root coverage percentage and other clinical outcomes in patients treated with coronally advanced flap and de-epithelialized gingival graft using conventional and microsurgical approach.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age >18 years Single or multiple teeth with RT1 Gingival Recession present bilaterally Systemically healthy patient Good level of oral hygiene with Full Mouth Bleeding Scores (FMBS) <20% and Full Mouth Plaque Index Score (FMPS) <20% Vital teeth free from dental caries No history of periodontal surgery in the preceding 6 months which can interfere with healing.
  • Non-smokers.

排除标准

  • With known systemic illness such as diabetes mellitus, arthritis and osteoporosis Patients on systemic medications such as corticosteroids or calcium channel blockers taking long term NSAIDS or taking bisphosphonates or calcium supplements.
  • Use of tobacco in any form and alcohol Teeth with Grade II and Grade III mobility Immunocompromised individuals Pregnant or lactating females Tooth with hopeless prognosis Non-vital tooth with or without periapical pathology History of radiotherapy in the preceding 1 year in head and neck region.

结局指标

主要结局

Mean root coverage

时间窗: 3 months | 6 months

次要结局

  • Change in Probing depths, Clinical attachment levels, Full mouth bleeding index, Plaque index(3 months)

研究者

发起方
A Ajaisha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

A Ajaisha

SCB dental college and hospital

研究点 (1)

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