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临床试验/CTRI/2021/04/032584
CTRI/2021/04/032584已完成不适用

Comparative evaluation of clinical, photographic parameters and patient reported outcomes in microneedling with and without i-PRF in thin gingival phenotype: A randomized clinical study

Dr Priyanka Sonavane1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年10月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
1.GT measurement

研究概览

简要总结

SUMMARYGingival phenotype isan important aspect of periodontium whichmaintains the health of the tissue as well as plays a decisive role inprediction of periodontal treatment outcomes. Thin gingival phenotype posescertain risks of poor periodontal treatment outcome in cases of implant,coronally advanced flap and other root coverage procedures and implants. Inthis study a non-surgical treatment modalities are being employed in an attemptto increase the thickness of thin gingival phenotype.

In this study the aimwas toevaluation of clinical, photographic parameters and patient reported outcomesin microneedling with and without i-PRF in thin gingival phenotype.Thirty Systemicallyhealthy subjects with thin gingival phenotype was included in this study. Thelower anterior teeth were randomly divided into two halves by flip coin method,in which the one side is treated with Microneedling (MN) + i-PRF (Group 1) andanother was treated by Microneedling alone (Group 2). The procedure wasrepeated for 4 times in an interval of 10 days. Measurement of GingivalThickness (GT), Width of Keratinized Tissue (WKT), Oral Hygiene Index (OHI),Gingival Index (GI) and Patient reported outcome measurement (PROM) whichincluded Pain, swelling, discomfort and redness was assessed.

Follow up of all the patientswas done till 6 months. Fromthe baseline to 6 months, both the groups showed statistical significantimprovement in the gingival thickness (P < 0.001). No significantimprovement in WKG in both the groups. The intergroup comparison showed highlystatistical significant increment in GT. Photographic analysis by RGB and L* a*b* showed highly statistical significant changes from baseline to 6 months. Ingroup 1 there was significant variation in PROM from baseline to 7 days. PROMin group 2 showed statistical significant changes in Visual analogue scale andredness. Overall better comfort was observed in group 2 in PROM.

Thus, this study concludes that microneedling along with i- PRF provides significantimprovement in thickness of gingiva. This study is first study of its kind toconduct photographic analysis and patient reported outcomes to measure innon-surgical periodontal therapy. The photographic analysis showed changes frombaseline to 6 months suggestive of changes in gingiva. Patient reportedoutcomes measurement enable us to analyse the patient’s perception regardingtreatment which showed overall better comfort in microneedling group.  Hence, this non-surgicaltreatment modality can be used improve the gingival phenotype of the patientswith minimal discomfort and without need of surgery in cases of thin gingivalphenotype.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1 Systemically healthy adults 2 Non-smoker 3 Patients with thin biotype (probe visibility)in mandibular anterior teeth with gingival 4 Thickness < 0.8 mm 5 Healthy gingiva with GI score less than 1 6 No history of use of Antibiotic last 1 month 7 No history of previous periodontal surgery in last 6 months.

排除标准

  • 1 Active orthodontic treatment 2 Fillings, missing or supernumerary mandibular teeth 3 High frenal attachment ,TFO, bruxism 4 Pregnant and lactating women.

结局指标

主要结局

1.GT measurement

时间窗: baseline , 10 days , 4 months , 7 months

2.Width of keratinized

时间窗: baseline , 10 days , 4 months , 7 months

tissue

时间窗: baseline , 10 days , 4 months , 7 months

次要结局

  • 1 Plaque index(2 Gingival index)

研究者

发起方
Dr Priyanka Sonavane
申办方类型
Other [self]

研究点 (1)

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