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临床试验/CTRI/2024/04/066034
CTRI/2024/04/066034尚未招募2 期

Comparison of low level laser therapy and oxygen based oral gel as an adjunct to scaling and root planing on gingival inflammation in orthodontic patients with fixed appliances A split mouth randomized trial.

radhika hedda1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2024年5月17日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
11
试验地点
1
主要终点
1. To assess the efficacy of –

研究概览

简要总结

Research question - What are the comparative effects of low level laser therapy and oxygen based oral gel on reducing gingival inflammation in orthodontic patients with fixed appliances?

-OBJECTIVE OF THE STUDY-

  1. To assess the efficacy of –

- Low level LASER therapy (LLLT) in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

- Oxygen based oral gel in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

- Scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

 2. To compare the efficacy of above treatment modalities

INCLUSION CRITERIA-

  • Aged between 17 and 25 years who received active orthodontic treatment for at least 4 to 6 months.

  • Participants with at least 24 natural teeth (excluding 3rd molars).

  • Participants with gingival index score of more than 1 (Loe and Silness, 1963)

 EXCLUSION CRITERIA-

  • Medically compromised patients

  • Those requiring special health care needs

  • Patients having a history of antibiotic intake for last 3 months.

  • Patients who had used any type of antibacterial mouthwash 2 weeks before the study Ø smokers

  • Pregnant or lactating women

 STUDY PROCEDURE

- Screening for selection of patients

- Full mouth scaling and root planning will be done for all patients

- Allocation of groups (split mouth technique)

GROUP  A- oxygen based oral gel(blue®m gel)

GROUP B -Low-level LASER therapy,(IndiLaseâ„¢ 660nm wavelength)

GROUP C1-Control (Scaling and root planing)

GROUP C2-Control (Scaling and root paning)

The following clinical parameters will be recorded at baseline,

7th and 14th day –

1.      Gingival index (GI) [Loe and Silness, 1963]

2.      Plaque index (PI) [Silness and Loe, 1964]

3.      Gingival bleeding index (GBI) [Ainamo and Bay, 1975]

Patients of all groups will be given uniform oral hygiene instructions.

 Benefits from study –

Fixed orthodontic appliances make oral hygiene maintenance difficult and may result in gingivitis. Adjunctive oral hygiene procedures such as SRP, application of topical gel or laser irradiation may be beneficial.

研究设计

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

入排标准

年龄范围
17.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • INCLUSION CRITERIA- 1) Aged between 17 and 25 years who received active orthodontic treatment for at least 4 to 6 months.
  • Participants with at least 24 natural teeth (excluding 3rd molars).
  • Participants with gingival index score of more than 1 (Loe and Silness, 1963).

排除标准

  • EXCLUSION CRITERIA- 1) Medically compromised patients 2) Those requiring special health care needs 3) Patients having a history of antibiotic intake for last 3 months.
  • Patients who had used any type of antibacterial mouthwash 2 weeks before the study  smokers 5) pregnant or lactating women.

结局指标

主要结局

1. To assess the efficacy of –

时间窗: 14 days

a) Low level LASER therapy (LLLT) in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

时间窗: 14 days

b) Oxygen based oral gel in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

时间窗: 14 days

c) Scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

时间窗: 14 days

次要结局

  • To compare the efficacy of LLLT, oxygen based oral gel and scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

研究者

发起方
radhika hedda
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr Radhika Hedda

Shri Dharmasthala Manjunatheshwara university

研究点 (1)

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