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临床试验/NCT06432439
NCT06432439已完成不适用

Microneedling And Its Effect On Outcome Of Root Coverage With Coronally Advanced Flap Involving Isolated RT1 Maxillary Gingival Recession In Thin Gingival Phenotype: A Randomized Controlled Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Recession Depth

研究概览

简要总结

Gingival Recession (GR) is a common finding among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures.

A flap thickness of > 0.8 mm results in 100% root coverage, whereas a flap thickness of < 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure.

The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype.

详细描述

Gingival recession (GR) is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. GRs are of 3 types with reference to interdental clinical attachment loss as Recession Type (RT) RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap (CAF) is a simple and predictable treatment of gingival recession defects. It has been observed that a flap thickness of > 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of < 0.8 mm results in partial root coverage in CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype.

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
Single (Participant)

入排标准

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

入选标准

  • •Presence of isolated Recession Type 1 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
  • •Gingival Recession ≥2mm and clinically identifiable CEJ
  • •Age 20years-50 years
  • •Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 therapy Plaque index (PI) <1, Gingival Index (GI) <1
  • •Providing a written and verbal informed consent.

排除标准

  • •Patient with systemic disease that can influence the outcome of therapy.
  • •Pregnant females or on oral contraceptive pills or hormone replacement therapy.
  • •Smokers and patients undergoing orthodontic therapy
  • •Physically and mentally impaired patients.
  • •Non vital, malpositioned tooth
  • •Presence of cervical abrasions or restorations in the area
  • •Previous history of periodontal surgery on the involved sites.

研究组 & 干预措施

TEST GROUP

Experimental

Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures

干预措施: microneedling followed by CAF procedures (Procedure)

CONTROL GROUP

Active Comparator

Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone.

干预措施: CAF procedure (Procedure)

结局指标

主要结局

Recession Depth

时间窗: 6 months

recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.

RECESSION WIDTH (RW)

时间窗: 6 months

recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.

ROOT COVERAGE PERCENTAGE

时间窗: 6 months

calculated in % according to the formula Root Coverage percentage = Recession depth (preop-postop)\*100 Recession depth preoperative

Gingival thickness(GT)

时间窗: 6 months

GT is calculated in mm and measured with the help of No:15 endodontic spreaders with silicon disc as stopper was inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue was felt. The depth of penetration was noted using digital calliper

次要结局

  • CLINICAL ATTACHMENT LEVEL (CAL)(6 months)
  • Probing Pocket Depth (PPD)(6 months)
  • Bleeding on Probing (BOP)(6 months)
  • Plaque Index (PI)(6 months)
  • Gingival Index (GI(6 months)
  • Keratinized Tissue Width (KTW)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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