Effect of Injectable Platelet-Rich Fibrin Combined With Microneedling, With and Without Local Vitamin C Injection, on Gingival Phenotype Augmentation: A Randomized Split-Mouth Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Between-Side Difference in Change in Gingival Thickness From Baseline to 3 Months
研究概览
简要总结
This randomized split-mouth clinical trial will evaluate whether adding locally injected vitamin C to injectable platelet-rich fibrin (i-PRF) and microneedling improves gingival tissue thickness and keratinized tissue width in women with a thin gingival phenotype in the lower front teeth region.
Each participant will receive i-PRF and microneedling on both sides of the lower anterior region. One side will additionally receive vitamin C, while the opposite side will receive normal saline as a placebo. The treatment will be repeated after 4 weeks. Gingival measurements will be taken at baseline, 3 months, and 6 months after the second treatment session. Patient satisfaction will also be assessed during follow-up.
详细描述
This study is a randomized, triple-blinded, split-mouth controlled clinical trial conducted in the Master Clinic of Periodontology at the University of Science and Technology, Aden, Yemen. The study will include female participants aged 18-65 years with a thin gingival phenotype in the anterior mandibular region.
Both sides of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF). On the test side, locally administered vitamin C will be given as a separate sequential injection in close proximity to the i-PRF injection site within the same treatment zone. On the control side, normal saline will be administered in the same manner as placebo. The intervention will be repeated after 4 weeks.
Gingival thickness and keratinized tissue width will be assessed at baseline and during follow-up at 3 and 6 months after the second treatment session. The study will also assess the stability of gingival augmentation over time and patient-reported esthetic satisfaction.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, the treating operator, and the outcome assessor will be blinded to treatment allocation. Vitamin C and normal saline will be provided in coded syringes labeled A and B, and the allocation code will remain concealed during treatment and outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy female participants.
- •Age 18 to 65 years.
- •Thin gingival phenotype (<1.5 mm).
- •No known blood disorders.
- •Good oral hygiene.
排除标准
- •Pregnancy.
- •Use of medications known to cause gingival enlargement.
- •History of trauma from occlusion or bruxism.
- •Previous soft-tissue grafting or periodontal soft-tissue surgery at the study sites.
- •Heavy smoking (>10 cigarettes per day).
- •Known allergy or hypersensitivity to vitamin C.
- •Use of vitamin C supplementation within the previous 2 months.
研究组 & 干预措施
Test Side: i-PRF + Microneedling + Vitamin C
One randomly assigned side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential local vitamin C injection. The intervention will be repeated after 4 weeks.
干预措施: Microneedling (Procedure)
Test Side: i-PRF + Microneedling + Vitamin C
One randomly assigned side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential local vitamin C injection. The intervention will be repeated after 4 weeks.
干预措施: Injectable Platelet-Rich Fibrin (i-PRF) (Biological)
Control Side: i-PRF + Microneedling + Placebo
The contralateral side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential normal saline injection as placebo. The intervention will be repeated after 4 weeks.
干预措施: Microneedling (Procedure)
Control Side: i-PRF + Microneedling + Placebo
The contralateral side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential normal saline injection as placebo. The intervention will be repeated after 4 weeks.
干预措施: Injectable Platelet-Rich Fibrin (i-PRF) (Biological)
Control Side: i-PRF + Microneedling + Placebo
The contralateral side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential normal saline injection as placebo. The intervention will be repeated after 4 weeks.
干预措施: Normal Saline Placebo (Drug)
Test Side: i-PRF + Microneedling + Vitamin C
One randomly assigned side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential local vitamin C injection. The intervention will be repeated after 4 weeks.
干预措施: Vitamin C (Drug)
结局指标
主要结局
Between-Side Difference in Change in Gingival Thickness From Baseline to 3 Months
时间窗: Baseline and 3 months after the second treatment session
Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. For each participant, the change in gingival thickness from baseline to 3 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.
Between-Side Difference in Change in Keratinized Tissue Width From Baseline to 3 Months
时间窗: Baseline and 3 months after the second treatment session
Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a periodontal probe. For each participant, the change in keratinized tissue width from baseline to 3 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.
Between-Side Difference in Change in Gingival Thickness From Baseline to 6 Months
时间窗: Baseline and 6 months after the second treatment session
Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. For each participant, the change in gingival thickness from baseline to 6 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.
Between-Side Difference in Change in Keratinized Tissue Width From Baseline to 6 Months
时间窗: Baseline and 6 months after the second treatment session
Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a periodontal probe. For each participant, the change in keratinized tissue width from baseline to 6 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.
次要结局
- Within-Side Change in Gingival Thickness From Baseline to 3 Months(Baseline and 3 months after the second treatment session)
- Within-Side Change in Keratinized Tissue Width From Baseline to 3 Months(Baseline and 3 months after the second treatment session)
- Within-Side Change in Gingival Thickness From Baseline to 6 Months(Baseline and 6 months after the second treatment session)
- Within-Side Change in Keratinized Tissue Width From Baseline to 6 Months(Baseline and 6 months after the second treatment session)
- Stability of Gingival Thickness From 3 to 6 Months(3 and 6 months after the second treatment session)
- Stability of Keratinized Tissue Width From 3 to 6 Months(3 and 6 months after the second treatment session)
- Between-Side Difference in Patient-Reported Esthetic Satisfaction at 3 and 6 Months(3 and 6 months after the second treatment session)
- Association Between Baseline Platelet Count and Change in Gingival Thickness(Baseline to 6 months after the second treatment session)
研究者
Waddah Abdulnasser Noman Al-Hajj
Associate Professor of Periodontology and Oral Medicine
University of Science and Technology, Yemen