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临床试验/CTRI/2025/08/092482
CTRI/2025/08/092482尚未招募4 期

Efficacy of cotton-candy flavored edible oil and audio-visual therapy on pain perception and anxiety among children aged 6-9 years on administration of inferior alveolar nerve block: A Randomized Clinical trial.

Simran Deorukhkar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To evaluate and compare efficacy of sugar free cotton candy flavored edible oil and audio-visual therapy on pain perception and dental anxiety in children on administration of local anesthesia.

研究概览

简要总结

Brief Resume of the intended work

7.1 Need for the study :

The success rate of any dental treatment in pediatric patients depends upon certain factors which include, the successful Behaviour management of the child, relieving the fear and anxiety associated with the treatment and the quality of the treatment provided.  The main aim of behavior management is to alleviate child’s fear and anxiety during dental treatment.

  The main fear of children while visiting the dentist is trypanophobia. Inferior alveolar nerve block is most commonly used during dental visit. Children become uncooperative while administration of local anesthesia1 and hence various techniques have been used to make them more comfortable during the procedure.

  Audiotherapy has proved to be useful distraction technique in children . Children prefer listening to rhymes while undergoing dental treatment.  Music sends enough concurrent sensory  inputs through descending pathways of the brain to cause the brain stem to signal some of the closed gates, thereby reducing the amount of pain the patient hearing the music

perceive2

  Sucrose Analgesia is one of the recent advances. Sweet taste solution play an important role in distracting children during dental treatment. They act on first and second order neuron, thereby reducing the pain threshold.3

 Hence a present study is undertaken to compare both the techniques in terms of pain perception and dental anxiety in children.

.2 Review of Literature :

1.     Ola B. Al-Batayneh (2024) et al conducted a study on efficacy of sugar free flavor on pain perception before local anesthesia in children. This was a split mouth randomized crossover clinical trial. Pain perception was checked by application of sugarfree flavor before administration of local anesthesia. This study concluded that using a sugarfree flavor helps in reducing pain before local anesthesia.4

 2.     Ishani Ratnaparkhi (20224) et al conducted a study on efficacy of sucrose application in minimizing pain perception in dental injections in children. This was a randomized clinical trial. Sucrose solution was applied on lateral surface of the tongue and pain perception was checked before administering local anesthesia. This study concluded that application of sucrose before local anesthesia minimizes the pain in children.5

   3.     Devendra Nagpal (2023) et al conducted a study on effect of audio distraction and thermomechanical stimulation on pain perception in children. This was a randomized clinical trial. Thermomechanical stimulation along with audio therapy was used to assess the pain perception in children. This study concluded that less pain on injection was observed when audio distraction along with thermomechanical stimulation was used.6

 4.     Supriya Thambireddy (2023) et al conducted a study on alleviating needle pain using sucrose solution before administering inferior alveolar nerve block in children. This was a randomized clinical trial. 30% sucrose solution was given before administering local anesthesia and pain perception was assessed. This study concluded that oral administration of sucrose reduces pain of local anesthesia in children.7

   5.     Gonzalo A. Rojas-Alcayaga (2018) et al conducted a study on effect of music therapy on dental anxiety in children. This was a randomized clinical trial. Children were exposed to musical distraction and anxiety of child during dental treatment was assessed. This study concluded that music distraction had no significant effect on dental anxiety. 8

7.3 Aim of Study :

To compare efficacy of audiotherapy and sugarfree oil-flavor on pain perception and dental anxiety in children on administration of local anesthesia.

1.To evaluate efficacy of sugar free cotton candy flavored edible oil on pain perception and dental anxiety in children on administration of local anesthesia.

  2.To evaluate efficacy of audio-visual therapy on pain perception and dental anxiety in children on administration of local anesthesia.

   3.To evaluate and compare efficacy of sugar free cotton candy flavored edible oil and audio-visual therapy on pain perception and dental anxiety in children on administration of local anesthesia.

研究设计

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

入排标准

年龄范围
6.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • 1.Healthy children of age 6 to 9 years.
  • 2.Frankl’s behavior rating score 2 and
  • 3.Mandibular carious molar undergoing procedures requiring inferior alveolar nerve block.

排除标准

  • 1.Frankl’s behavior rating score 1 and
  • 2.Children with special health care needs.
  • 3.Children with hearing problems.
  • 4.Children with systemic diseases.

结局指标

主要结局

To evaluate and compare efficacy of sugar free cotton candy flavored edible oil and audio-visual therapy on pain perception and dental anxiety in children on administration of local anesthesia.

时间窗: Post application

次要结局

  • To evaluate efficacy of sugar free cotton candy flavored edible oil on pain perception & dental anxiety in children on administration of local anesthesia.

研究者

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

Simran Deorukhkar

Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune

研究点 (1)

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