EFFECT OF LASER PATTERNED MICROCOAGULATION TREATMENT IN GINGIVAL BIOTYPE CONVERSION AROUND IMPLANTS.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1.Assessment of gingival thickness using transgingival probing.
研究概览
简要总结
Brief Summary
Rationale and Gaps in Existing Knowledge:
Various surgical techniques such as connective tissue grafts and enamel matrix derivatives have been used for phenotype modification to increase soft tissue thickness and improve treatment outcomes. However, these procedures require high surgical skill and may result in reduced patient compliance. To overcome these limitations, a minimally invasive microsurgical approach using Laser Patterned Micro Coagulation (LPM) has been developed to enhance gingival tissue quality. LPM helps in converting a thin gingival biotype into a thicker one, which is especially important in implant dentistry.
Novelty:
LPM may have potential applications in the management of gingival recession and stimulation of growth and regeneration of interdental and inter-implant papillae.
Objectives:
The aim of the study is to modify the gingival biotype around implants by using laser patterned micro coagulation.
Methods:
A total of 24 participants will be included, with 12 in each group. The study will evaluate gingival biotype changes around implants at 3 and 6 months with a 95 percent confidence interval and 80 percent power.
At the test site, a diode laser with wavelength 940 nm and 200 micrometer tip will be applied in pulsed contact mode. In the control group, local anesthesia will be administered and microneedling will be performed using Dr Pen Ultima A6 applied perpendicularly to the soft tissue until bone contact is achieved.
Outcomes:
Primary outcomes include assessment of gingival thickness by transgingival probing, width of keratinized tissue, clinical attachment level, and bleeding on probing according to Mombelli et al. Secondary outcomes include peri-implant plaque index and modified gingival index according to Lobene et al.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Systemically healthy patients with greater than 18 years of age.
- •2.Patient with gingival phenotype thickness less than 1.5mm.
- •3.Patient having inadequate width of attached gingiva.
排除标准
- •1.Medically compromised patients.
- •2.Pregnant and lactating women.
- •3.Patient undergoing orthodontic treatment.
- •4.Patient having preexisting mucogingival deformities.
- •5.Patient taking any medication that causes gingival enlargement.
结局指标
主要结局
1.Assessment of gingival thickness using transgingival probing.
时间窗: 2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin ) | using UNC-15 probe at baseline and post operatively, at baseline 3 months and 6 months . | 3.Assessment of clinical attachment level by using UNC-15, at baseline 3 months and 6 months. | 4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al, at baseline 3 months, 6 months.
2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin )
时间窗: 2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin ) | using UNC-15 probe at baseline and post operatively, at baseline 3 months and 6 months . | 3.Assessment of clinical attachment level by using UNC-15, at baseline 3 months and 6 months. | 4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al, at baseline 3 months, 6 months.
using UNC-15 probe at baseline and post operatively.
时间窗: 2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin ) | using UNC-15 probe at baseline and post operatively, at baseline 3 months and 6 months . | 3.Assessment of clinical attachment level by using UNC-15, at baseline 3 months and 6 months. | 4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al, at baseline 3 months, 6 months.
3.Assessment of clinical attachment level by using UNC-15.
时间窗: 2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin ) | using UNC-15 probe at baseline and post operatively, at baseline 3 months and 6 months . | 3.Assessment of clinical attachment level by using UNC-15, at baseline 3 months and 6 months. | 4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al, at baseline 3 months, 6 months.
4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al
时间窗: 2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin ) | using UNC-15 probe at baseline and post operatively, at baseline 3 months and 6 months . | 3.Assessment of clinical attachment level by using UNC-15, at baseline 3 months and 6 months. | 4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al, at baseline 3 months, 6 months.
次要结局
- 1.Assessment of peri implant plaque index according to Mombelli et.al, at baseline 3 months, 6 months.(2.Assessment of modified gingival index - according to Lobene et.al, at baseline 3 months & 6 months.)
研究者
Dr Rathod Srikanth
Svs institute of dental sciences