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临床试验/CTRI/2025/10/095883
CTRI/2025/10/095883尚未招募4 期

Comparative evaluation of warm, buffered articaine vs buffered articaine for buccal infiltration of primary tooth for pulp therapy procedures: a split mouth design clinical trial.

Devadhakshayani V1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年10月24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
34
试验地点
1
主要终点
Identify which method of Local Anesthetic administration is less painful using Wong bakers pain scale at baseline

研究概览

简要总结

Pain management is an extremely important step in behaviour management of   children in pediatric dental practice. Local anesthesia (LA) is the transient loss of sensation in a specific area of the body caused by the depression of nerve ending excitation or inhibition of conduction in the peripheral nerves. Although local anesthetic injections cause pain and anxiety in children, they are an integral part of dental treatment for comfortable, cooperative, and pain-free dental treatment. The site and speed of injection and the pH of the anesthetic solution have all been linked to pain during LA administration. Various techniques have been suggested to alleviate pain during injection. Warming the local anaesthetic solution to a body temperature found to be effectively reducing pain during dental procedures.

Another technique to reduce pain is neutralization of the pH of a LA solution by buffering with sodium bicarbonate immediately before injection which also shortens the onset time and improve the clinical efficacy of LAs. While lidocaine has been the gold standard local analgesia for past many years there are other effective agents like articaine has become increasingly popular in dentistry. Articaine hydrochloride is an amide type of local analgesia. It acts in similar way to other amide analgesia but its unique chemical structure offers advantages over traditional amide analgesia’s. Articaine is the only amide analgesia’s to contain an ester group and this allows it to be rapidly broken down to its inactive state thus decreasing systemic toxicity. Articaine is more lipid soluble and more potent thereby enabling it to diffuse more readily through both hard and soft tissues, making it 1.5times more potent than lidocaine.

Articaine 4% 1:100,000 is reported to be well tolerated, safe and effective local analgesia for use in children. A literature search found that no studies have been conducted on the comparison of buffered and warmed articaine with buffered articaine. The aim of this study is to evaluate and compare the efficacy of warm and buffered articaine with buffered articaine in the pulp therapy of a primary teeth.

AIM To determine the anesthetic effect of warm and buffered articaine with buffered articaine in pulp therapy of a primary teeth

 OBJECTIVES To evaluate the anesthetic effect of buffered and warmed articaine in pulp therapy of a primary teeth

To evaluate the anesthetic effect of buffered articaine in pulp therapy of a primary teeth

To compare the anesthetic effect of buffered and warmed articaine versus buffered articaine in pulp therapy of a primary teeth.

METHOD

Study design: Clinical comparative study

Hypothesis: There is no difference between the anesthetic effect of warm and buffered articaine and buffered articaine in pulp therapy of a primary teeth.

Sample size: 34 Children

Source of study: Children coming to the Department of Pediatric and Preventive Dentistry, VMSDC, Salem.

Duration: 6 months (after ethical committee clearance)

Study population: A total of 34 children between 6-10 years will be included in this study.

Inclusion criteria

Children aged 6-10  years

Children exhibiting Frankel’s behavior rating of grade 3 and 4 (Positive and Definitely Positive)

Children with bilateral deep caries with pulpal exposure

Class I and class II relying on ASA classification

Exclusion Criteria

Considerable behavior problems

Children with systemic conditions

Parents who refuse to participate in the study.

Randomization

An informed consent from the parent visiting the Department of Pediatric and Preventive Dentistry, VMSDC, Salem will be obtained. The study participants will be allocated by simple randomization.

Methodology

Participants requiring bilateral pulpotomy and pulpectomy procedures will be selected. On the first visit the children will be subjected to a thorough dental checkup, and radiographs of the offending teeth will be taken. Children with primary teeth on both right and left sides affected with deep dentinal caries, requiring pulp therapy will be selected for the study.

Wong Bakers Faces Pain Scale will be shown to the children and make them familiarized with it.

In the first appointment one side of the mouth will be administered with a buccal infiltration of warm and buffered articaine and the pain will be assessed by using Wong Bakers Faces Pain Scale. The physiological parameters such as pulse and heart rate will be recorded using a pulse oximeter.

In the second appointment after a week the other side of the mouth will be administered with a buccal infiltration of buffered articaine and the pain will be assessed by using Wong Bakers Faces Pain Scale.

In order to make a buffered solution 1.7 ml cartridge of 4% articaine with 1:100000 adrenaline will be used, from which 0.2 ml of anaesthetic solution will be taken out and it will be replaced with 0.2ml of 8.4% sodium bicarbonate. The ratio between the dental local anaesthetic and 8.4% sodium bicarbonate will be 9:1.

Warming of the local anaesthetic solution will be done by thermostatic heat bath or baby bottle warmer.

Buccal infiltration of articaine will be given

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 and Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children exhibiting Frankel’s behavior rating of grade 3 and 4 (Positive and Definitely Positive) Children with bilateral deep caries with pulpal exposure Class I and class II relying on ASA classification.

排除标准

  • Considerable behavior problems Children with systemic conditions Parents who refuse to participate in the study.

结局指标

主要结局

Identify which method of Local Anesthetic administration is less painful using Wong bakers pain scale at baseline

时间窗: Before Administration Of LA | during Administration of LA | At baseline after administration of LA

次要结局

未报告次要终点

研究者

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

Devadhakshayani V

Vinayaka missions sankarachariyar dental college

研究点 (1)

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