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临床试验/CTRI/2024/06/069675
CTRI/2024/06/069675已完成不适用

The effectiveness of micro needling technique using coconut oil and vitamin C on the severity of gingival inflammation and plaque accumulation in patients with Stage I Periodontitis – A Randomized clinical trial

Joshua Carlos Misquita1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年11月5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
36
试验地点
1
主要终点
Micro needling with Vitamin C and Coconut oil decreases gingival inflammation and plaque accumulation in patients with stage I periodontitis

研究概览

简要总结

·       Subjects with severity of gingival inflammation and plaque accumulation will be selected from the Department of Periodontics OPD, Coorg Institute of Dental Sciences, Karnataka

·       Before the start of the study, written consent will be taken from the subjects of all the groups.

·       All subjects were subjected to professional mechanical scaling via a Piezoelectric ultrasonic scaler to remove calculus and soft deposits.

·       In addition, they were given oral hygiene instructions before treatment, including proper tooth brushing techniques and flossing only.

·       No mouthwash (MW) prescribed to the subjects.

·       Subjects were allocated randomly to either of the following groups;

·       18-40 years old subjects with severity of gingival inflammation and plaque accumulation who were treated with topical coconut oil using derma pen will be allocated in Group A and 18–40-year-old subjects with severity of gingival inflammation and plaque accumulation who were treated with vitamin C paste solution using derma pen will be allocated in Group B using random sampling method.

·       For each subject in Group A local anaesthesia of 2% lignocaine (1:80,000 adrenaline) was administered by infiltration technique in the anterior maxillary region.

·       To microneedle the mucosa, derma pen needles (head/subject) were used in an intermittent stamp like motion on the sextant gingival area for 30-40s/tooth with a depth of 1.5mm.

·       When uniform bleeding pinpoints were observed, coconut oil were applied by cotton roll on the upper anterior region of the gingiva (gingival sulcus, gingival margin and attached gingiva from canine to canine in a circular motion.

·       The cotton roll was left on the keratinized gingiva for 5 mins.

·       Subject were instructed to refrain from drinking acidic or hot beverages for 24hr and to not brush their teeth for 1 day to avoid any mechanical trauma to the gingiva.

·       Each subject will be reviewed for evaluation at four time points.

·       The first tissue evaluation of Micro needling technique will be scheduled before treatment (baseline).

·       Clinical examination will be done 1 week after treatment, 2 weeks after treatment & 4 weeks after treatment.

·       For each subject in Group B local anaesthesia 2% lignocaine (1:80000 adrenaline) was administered by infiltration technique in the anterior maxillary region.

·       To microneedle the mucosa, derma pen needles (head/subject) were used in an intermittent stamp like motion on the sextant gingival area for 30-40s/tooth with a depth of 1.5mm.

·       When uniform bleeding pinpoints were observed on all areas of gingiva, the gingival mucosa was irrigated with a saline solution and sterile gauze was applied to dry the area.

·       Then, topical AA powder (1000mg/ml) was mixed with saline in a small glass dish forming a paste.

·       The mixed slurry paste was applied to the gingival mucosa using for 10 mins.

·       The treated area was left without dressing.

·       Subject were instructed to refrain from drinking acidic or hot beverages for 24hr and to not brush their teeth for 1 day to avoid any mechanical trauma to the gingiva.

·       Each subject will be reviewed for evaluation at four time points.

·       The first tissue evaluation of Micro needling technique will be scheduled before treatment.

·       Clinical examination will be done 1 week after treatment, 2 weeks after treatment & 4 weeks after treatment.

For each patient in Group C subjects were advised to continue only routine oral prophylaxis

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Male and female health-conscious subjects.
  • Age ranges from 18-40 years.
  • Subjects suffering from moderate to severe gingival inflammation.
  • Redness, bleeding and inflammation of the aesthetic area (upper six anterior teeth).
  • Presence of plaque & calculus on dental surfaces.
  • Undergone no previous treatment that had affected gingival health.
  • Willingness and ability to complete the clinical trial.

排除标准

  • Poorly motivated and/or poorly collaborating subject.
  • Subject undergoing treatment with hormones.
  • Subject allergic to coconut.
  • Subject with bone loss or osteoporosis.
  • Missing one or more of the upper anterior teeth.
  • Medication induced gingival enlargement.
  • Subject with smoking and other tobacco-related habits.

结局指标

主要结局

Micro needling with Vitamin C and Coconut oil decreases gingival inflammation and plaque accumulation in patients with stage I periodontitis

时间窗: Decrease in plaque accumulation and gingival inflammation after 1 week, 2 weeks and 4 weeks after treatment

次要结局

  • Scaling and root planing with micro needling decreases gingival inflammation and plaque accumulation in patients with stage I periodontitis as compared with Vitamin C and coconut oil(1 week, 2 weeks , 4 weeks)

研究者

发起方
Joshua Carlos Misquita
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Joshua Carlos Misquita

Coorg Institute of Dental Sciences

研究点 (1)

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