Evaluation of Gingival Thickness and Root Coverage Outcomes Following Coronally Advanced Flap Combined With Microneedling With or Without Cross-Linked Hyaluronic Acid in RT1 Recession Defects: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Gingival thickness
研究概览
简要总结
In patients with single RT1 recessions and thin gingival phenotype, does adding cross-linked hyaluronic acid by microneedling after CAF surgery produce greater gingival thickness gain and higher probability of complete root coverage at 6 months than microneedling alone?
详细描述
The aim of this study is to evaluate changes in gingival thickness and root coverage outcomes after coronally advanced flap (CAF) then cross-linked hyaluronic acid injection along with performing microneedling in patients with RT1 single gingival recession with thin gingival phenotype in esthetic region.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria
- •Adult (≥18 years) with Single RT1 gingival recession in esthetic zone.
- •Thin gingival biotype (≤ 1mm).
- •Systemically healthy patients.
- •Non- smoker patients.
- •Full-mouth bleeding on probing (BOP) and plaque indices (PI) scores ≤15%.
- •Willingness to comply with follow up and maintenance.
排除标准
- •RT2 or RT3 recessions or multiple adjacent recessions.
- •Previous mucogingival surgery at the test site.
- •Use of medications causing gingival enlargement.
- •Uncontrolled systemic disease.
- •Pregnancy or lactation.
- •Current smokers.
研究组 & 干预措施
test group
Microneedling sessions will be performed 1 month after the CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. Then, cross-linked hyaluronic acid will be injected in a volume of 0.2mm of a 20 mg/ml concentration with particle size 400 μm. HA injection will be administrated until blanching of gingiva is evident. To ascertain that the HA is distributed evenly the region will be gently massaged for 2 to 3 min with a sterile gauze soaked in saline. This Microneedling technique with HA injection will be repeated four times at 10-day intervals.
干预措施: cross-linked hyaluronic acid (Combination Product)
control group
Microneedling sessions will be performed 1 month after CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. This method will be repeated four times at 10-day intervals.
干预措施: Microneedling (Device)
结局指标
主要结局
Gingival thickness
时间窗: 6-months post surgery
using a No.15 endodontic spreader with a silicon stopper placed 2 mm apical to the gingival margin at the mid-buccal aspect; depth of penetration measured with a ruler to the nearest 0.5 mm.
次要结局
- Recession Depth (RD)(6 months post surgery)
- Recession Width (RW)(6 months post surgery)
- Recession Reduction (Rec-Red)(6 months post surgery)
- Complete Root Coverage (CRC)(6 months post surgery)
- Percentage of Root Coverage (%)(6 months post surgery)
- Keratinized Tissue Width (KTW)(6 months post surgery)
- Clinical Attachment Level (CAL)(6 months post surgery)
- Probing Depth (PD)(6 months post surgery)
- Root Coverage Esthetic Score (RES)(6 months post surgery)
- Condition-specific Health-related Quality-of-life(6 months post surgery)
研究者
Tareq Mohammed Salah Ismail El Shamy
Assistant Lecturer
Cairo University