The Adjunctive Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation (A Randomized Clinical Trial With Histological Analysis)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Dummet oral pigmentation index
研究概览
简要总结
The objectives of the present study are to:
- Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective.
- Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.
详细描述
Dental esthetic needs are increasing in recent years with a greater demand on pleasant appearance; including a healthy set of dentitions but also esthetically improved gingival appearance, especially when it is located in the anterior labial region. Physiologic gingival hyperpigmentation affects numerous people of different ethnic backgrounds.
Gingival depigmentation is defined as a periodontal plastic surgical procedure that are aimed at removing the pigmented gingiva and methods aimed at masking the pigmented gingiva. Techniques of gingival depigmentation can be classified as; chemical methods mainly by ascorbic acids, surgical methods, electrosurgery, cryosurgery, radiosurgery, and lasers.
The study was conducted on eight patients seeking treatment for their gingival hyperpigmentation for esthetic reasons. A total number of 16 sites of facial gingival hyperpigmentation were treated, two in each patient in a split mouth technique.
- Group I (LASER with I-PRF): Included eight sites that were treated with laser technique for gingival depigmentation, followed by intramucosal field injection of I-PRF (as study group).
- Group II (LASER): Included eight sites that were treated with laser technique for gingival depigmentation (as a control group).
The clinical outcomes were assessed for each patient: at baseline (pre-operative), post-operative, one week, one month. Clinical assessment was done by measuring DOPI, clinical wound healing, VAS and patient satisfaction questionnaire.
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female with age range from 16 to 45 years old.
- •Systemically free from any disease as evidenced by the health questionnaire guided by modified Cornell medical index (Pendleton et al., 2004).
- •Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964).
- •Patient with thick gingival phenotype (>1.5mm) (Claffey and Shanley, 1986).
- •Exclusion Criteria
- •Pregnant and lactating women.
- •Gingival pigmentation associated with occupational Hazards.
- •Patients with missing anterior teeth.
- •Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment.
- •Vulnerable groups (prisoners, handicapped and orphans).
排除标准
- 未提供
结局指标
主要结局
Dummet oral pigmentation index
时间窗: 1 month
the degree of gingival pigmentation will be scored as: 0 = pink tissue \[no clinical pigmentation\]; 1 = mild light brown tissue \[mild clinical pigmentation\]; 2 = medium brown or mixed brown and pink tissue \[moderate clinical pigmentation\]; or 3 = deep brown/ blue-black tissue \[heavy clinical pigmentation\]
Clinical wound healing
时间窗: 1 week
scored as follows: 1\) Complete reepithelialization, 2) Incomplete reepithelialization, 3) ulcer and 4) tissue defect or necrosis
次要结局
- Satisfaction questionnaire(1month)
- Visual analogue scale (VAS) score for pain assessment(1month)
- Histological assessment(1 week)
研究者
Ola Mohamed Ezzatt
Associate Professor
Ain Shams University