Clinical Effectiveness Of Polishing Brush Compared to Ceramic Soft Tissue Trimming Bur In Gingival Depigmentation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- gingival pigmentation intensity
研究概览
简要总结
Gingival hyperpigmentation, particularly of melanin origin, can pose significant aesthetic concerns, especially among patients with a high smile line. Several depigmentation techniques have been proposed to manage this condition, including scalpel surgery, electrosurgery, cryotherapy, lasers, and various rotary instruments. Recently, minimally invasive rotary tools such as ceramic burs and polishing brushes have gained interest due to their potential to deliver controlled ablation with reduced postoperative discomfort and healing complications.
Ceramic soft tissue trimming burs are specially designed to remove superficial pigmented gingival layers with minimal trauma. However, these instruments may still generate heat and cause a degree of tissue damage. On the other hand, polishing brushes, traditionally used for surface finishing and stain removal, have recently been explored for soft tissue applications due to their gentle action and adaptability.
Despite their increasing use, there is insufficient comparative clinical evidence on the efficacy, healing outcomes, and patient-centered experiences between these two modalities in gingival depigmentation. A split-mouth randomized controlled trial design offers the advantage of eliminating inter-individual variability. Thus, this study aims to assess and compare the clinical effectiveness of the polishing brush and ceramic trimming bur for gingival depigmentation in terms of pigment reduction, healing outcomes, postoperative pain, and recurrence.
详细描述
This study is designed as a prospective randomized controlled clinical trial with a parallel intraoral comparison between two treatment modalities:
- Depigmentation using polishing brush and
- Depigmentation using ceramic soft tissue trimming bur. Participants will be randomly allocated into two independent groups, with each group receiving one of the two interventions on both sides of the arch. This parallel design ensures that each participant receives only one treatment modality, thereby preventing any crossover effects and allowing for between-subject comparison. Randomization will be conducted using a computergenerated sequence to ensure unbiased allocation. Blinding of the outcome assessor will be maintained to minimize assessment bias.
The trial will adhere to CONSORT guidelines, with baseline data collection followed by standardized clinical evaluations at predefined follow-up intervals to assess changes in gingival thickness and other relevant soft tissue parameters.
The study will be conducted at the Department of Oral Medicine and Periodontology, Faculty of Dentistry - Cairo University, Egypt.
Participants will be recruited from the outpatient clinic of the same department.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of melanin hyperpigmentation (Dummett Oral Pigmentation Index ≥ 2)
- •Presence of bilateral gingival pigmentation extending at least 3 teeth in each arch
- •Age range: e.g., 18-40 years (adjust based on your sample)
- •Non-smokers (or smokers <10 cigarettes/day, specify if allowed)
- •Systemically healthy
- •Willingness to participate and sign informed consent 8
- •Available for follow-up appointments
- •No previous periodontal surgery in the area other than prophylaxis
排除标准
- •• Systemic conditions affecting healing (e.g., diabetes mellitus,immunosuppressive disorders)
- •Pregnant or lactating women
- •Heavy Smokers
- •Ongoing orthodontic treatment in the affected area
- •Use of medications affecting gingiva (e.g., phenytoin, cyclosporine, calcium channel blockers)
- •Poor oral hygiene at baseline
- •Active periodontal pockets >3 mm or clinical attachment loss
- •Allergy to local anesthetics or materials used in the procedure
- •History of alcohol or drug abuse
- •Psychological conditions that may interfere with compliance
研究组 & 干预措施
Polishing brush
In the test group, gingival depigmentation will be performed using a polishing brush specifically adapted for soft tissue application. After administering local anesthesia, a silicon carbide or rubber-based polishing brush will be attached to a low-speed handpiece. The pigmented gingival epithelium will be gently abraded in a circular motion under light pressure until the superficial pigmented layer is removed and uniform pink gingiva is visible. Continuous irrigation with sterile saline will be used to prevent heat generation and ensure visibility. The operator will take care not to injure the underlying connective tissue. No periodontal dressing will be applied. Postoperative instructions will include gentle oral hygiene, avoiding hot or spicy foods, and use of 0.12% chlorhexidine mouthwash for 1 week.
干预措施: Gingival Depigmentation using polishing brush (Procedure)
Ceramic bur
In the control group, ceramic soft tissue trimming burs will be used to perform gingival depigmentation. After achieving local anesthesia, a flame- or round-shaped ceramic bur will be attached to a low-speed contra-angle handpiece. The bur will be used in a brushing motion to carefully remove the pigmented epithelial layer without applying excessive pressure. The clinician will maintain light, controlled strokes to avoid damaging the underlying lamina propria. As with the polishing brush technique, continuous irrigation with saline will be provided to cool the tissue and improve visibility. Once the pigmented areas are cleared and a healthy pink gingival color is achieved, the procedure will be concluded without any periodontal dressing. Postoperative care will follow the same protocol as the polishing brush group.
干预措施: Depigmentation using ceramic soft tissue trimming bur (Procedure)
结局指标
主要结局
gingival pigmentation intensity
时间窗: Baseline, 1 Week, 1 month and at 3 months
Dummett Oral Pigmentation Index (DOPI). This is an ordinal index that categorizes pigmentation on a 4-point scale: 0 = no pigmentation, 1 = mild, 2 = moderate, and 3 = heavy pigmentation.
次要结局
- Patient Satisfaction(At Baseline, and at 3 months.)
- Operating Time(Perioperative. From the start of the depigmentation procedure until the end of hemostasis and final inspection.)
- Pain Perception(Day 1, Day 3, 1 week, Day 10)
- Extent of Pigmentation(Baseline, 1 Week, 1 month and at 3 months)
- Wound Healing(1 week, 3 months)
- Recurrence Rate(1 week, 1 month, and 3 months.)
研究者
Raghad hisham
Principal Investigator Raghad Hisham
Cairo University