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临床试验/CTRI/2024/08/072090
CTRI/2024/08/072090尚未招募不适用

Clinical Evaluation of Gingival Wound Healing, Post-operative Satisfaction and Recurrence of Pigmentation with or without Injectable Platelet-Rich Fibrin in the Treatment of Gingival Hyperpigmentation using Diode LASER - A Split Mouth Study

Kamineni Institute of Dental Sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1
主要终点
visual analog scale

研究概览

简要总结

CLINICAL EVALUATION OF GINGIVAL WOUND HEALING, POST-OPERATIVE SATISFACTION, AND RECURRENCE WITH OR WITHOUT INJECTABLE PLATELET RICH FIBRIN IN THE TREATMENT OF GINGIVAL HYPERPIGMENTATION USING DIODE LASER -A SPLIT MOUTH STUDY.

Introduction:

An aesthetically satisfying smile plays an important role in the psychological wellbeing and self-confidence. There are various factors that determine the overall aesthetic of smile design, one of the important factors is the pink aesthetic (aesthetic of the gingival tissues), which can greatly influence the overall clinical appearance of the smile.

 In context of depigmentation, is the fact that lasers are an effective, minimally invasive, and often painless alternative to the conventional and traditional techniques of depigmentation. Lasers of a range of wavelengths in dentistry, from the visible spectrum such as the “blue” and “green” diode lasers (440, 532 nm), near infrared diode lasers (810, 940, 980 nm), mid-infrared lasers Nd:YAG (1064 nm), have a broad affinity for pigmented chromophores, including melanin. Diode laser treatment exhibited better long-term stability of gingival color, with a lower incidence of re-pigmentation.

 An autologous blood concentration known as i-PRF has been known for many years and primarily found in liquid form. The advantage of i-PRF is that it exhibits constant release of growth factors and promotes cell migration by announcing the expression of type I collagen and transforming growth factor mRNA.

 The study is thus proposed to evaluate and compare the role of the i-PRF in gingival wound healing, post-operative healing, and recurrence of pigmentation after gingival depigmentation using a diode laser both clinically which has not been reported in the literature.

Aim and objective

To evaluate, and compare the post-gingival depigmentation outcome - pain, wound healing, epithelization clinically and reoccurence of pigmentation for i-PRF+ diode laser and diode laser alone:

a) For visual analog scale (VAS) 3rd and 5th day and healing index (HI) at 3rd, at 5th day and 14th day,

b) Epithelization test using toluidine blue at 5th day and 14th day.

c) Evaluation of reoccurrence of pigmentation at 30th day, 90th day, and 180th day.

Material and Methods:

1.                  10 subjects satisfying inclusion and exclusion criteria will be enrolled from the out-patient section, Department of Periodontics, Kamineni Institute of Dental Sciences, Narketpally, Nalgonda (Dist), Telangana.

2.                  After allocating the patient for the gingival depigmentation, infiltration anaesthesia with 2% lignocaine with adrenaline 1:200,000 was administered. The entire visible pigmentation was removed, exposing the underlying connective tissue using diode laser at 980nm at 1st and 2nd quadrants.

3.                  For i-PRF preparation, 10ml of whole blood without anticoagulant will be centrifuged at 700 rpm for 3 min at room temperature. After 3 mins the straw-colored liquid present at the top which is i-PRF will be collected. Using insulin syringe 1ml of i-PRF liquid will be deposited intramucosally in 1st quadrant alone (Test group).

Inclusion criteria:

•                     Ages: 16-45 years old

•                     Systemically healthy

•                     Good oral hygiene

•                     Thick gingival biotypes

•                     Keratinized gingiva >2mm

Exclusion criteria:

•                     Smokers

•                     Taking any medications that could affect healing

•                     Pervious depigmentation procedures

•                     Pregnant or lactating females

•                     Pervious periodontal surgery within 6 months before the start of the trial

Sample size: The study consists of 10 subjects which will be done as a split mouth clinical trial. (n=10).

Group I: In all the patients the gingiva of 1st quadrant will be deposited with i-PRF intramucosally after depigmentation procedure using diode laser at 980nm.

Group II: In all the patients the gingiva of 2nd quadrant depigmentation procedure using diode laser at 980nm will be done alone.

Parameters:

Following parameters will be evaluated, and compared.

a)                  For visual analog scale (VAS) at 3rd and 5th day,

b)                  Healing index (HI) at 3rd, at 5th day, and at 14th day,

c)                  Epithelization test using toluidine blue on 5th day and 14th day.

d)                  Reoccurrence of pigmentation at 30th day, 90th day, and 180th day.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
16.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Ages: 16 to 45 years old Systemically healthy Good oral hygiene Thick gingival biotypes Keratinized gingiva more than 2mm.

排除标准

  • Smokers Taking any medications that could affect healing Pervious depigmentation procedures Pregnant or lactating females Pervious periodontal surgery within 6 months before the start of the trial.

结局指标

主要结局

visual analog scale

时间窗: 3rd day | 5th day | 14th day

Healing index

时间窗: 3rd day | 5th day | 14th day

Epithelization test using toluidine blue.

时间窗: 3rd day | 5th day | 14th day

次要结局

  • Reoccurrence of pigmentation

研究者

申办方类型
Other [Private Dental College]
责任方
Principal Investigator
主要研究者

Dr S Vidya Sagar

Kamineni Institute of Dental Sciences

研究点 (1)

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