Gingival Phenotype Modification Using Super-putty C-PRF/Hyaluronic Acid Combination Versus C-PRF Alone in Subjects With Thin Gingival Phenotype: Randomized Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid
研究概览
简要总结
Randomized split mouth clinical trials study focused on comparing the efficacy of C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype.
详细描述
Gingival phenotype is an important periodontal parameter focused on the gingival thickness and keratinized tissue width.
The gingival phenotype is either thin or thick. Thick gingival phenotype resist infections and periodontal disease more than the thin gingival phenotype.
Multiple surgical approaches to modify the ginigval phenotype from thin to thick has been done in clinical dentistry.
While surgical approach is invasive, recent periodontal trends tends to go with non-invasive ways to treat periodontal conditions. It involves PRF injections as an example.
In this study we're utilizing the PRF combination with Hyaluronic acid and inject this combination to increase the gingival thickness and keratinized tissue width.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy male or female adults aged 20 to 40 years.
- •Non-smoker.
- •Presence of a clinically thin gingival phenotype (gingival thickness ≤ 1.0 mm) at the targeted surgical sites.
- •Presence of bilateral homologous teeth (e.g., both maxillary canines, or both mandibular first premolars) exhibiting the same thin gingival phenotype to allow for paired test and control sites within the same oral cavity.
- •Patients must demonstrate a high standard of oral hygiene, defined as a full-mouth plaque score and full-mouth bleeding score of ≤ 10% following initial cause-related therapy.
- •Willingness to comply with the 6-month follow-up schedule and provide written informed consent before enrollment.
排除标准
- •Any systemic disease or condition known to compromise wound healing or alter immune response (e.g., uncontrolled diabetes mellitus, autoimmune disorders, bleeding dyscrasias).
- •Current or recent use of medications known to induce gingival enlargement (e.g., phenytoin, cyclosporine, calcium channel blockers) or medications affecting blood coagulation and platelet function (e.g., anticoagulants) within last 10 days of the procedure.
- •Active periodontitis, defined by probing depths > 3 mm or bleeding on probing at the designated experimental sites
- •Any previous history of mucogingival surgery, soft tissue grafting, or local trauma at the selected test or control sites.
- •Current tobacco smoking or vaping, due to its well-documented detrimental effects on local angiogenesis and soft tissue grafting outcomes.
- •Pregnant or lactating females, due to hormonal fluctuations that can temporarily alter the gingival tissue response and capillary permeability.
结局指标
主要结局
Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid
时间窗: baseline - 6 months follow up
Using Trans-ginval probing method to measure the gingival thickness and using Periodontal probe with 1 mm markings to measure the keratinzed tissue width, we measure the difference between the baseline and 6 month after the injection of C-PRF/ Hyaluronic acid and compare the readings with the other side that would be injected with C-PRF alone. (To make the assessments repeatable, we will fabricated a stent for each participant. Each stent has a specific hole to measure the gingival thickness through it in order to make the readings as accurate as possible and all the measurements will be in mm scale).
次要结局
未报告次要终点
研究者
Sajjad Ahmed Shakir
Master of Science in Periodontics
University of Baghdad