TCTR20201002008招募中2 期
Injection pain and anesthetic efficacy between buccal infiltration and either palatal infiltration or intraseptal injection in young permanent maxillary molar with deep caries in children: a non-inferiority randomized controlled trial
Faculty of Dentistry, Chiang Mai University0 个研究点目标入组 88 人开始时间: 2020年10月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Years 至 18 Years（—）
- 性别
- All
入选标准
- •Patient inclusion criteria
- •1.Patients aged between 6â€18 years old with the American Society of Anesthesiologists I or II (ASA I or II)
- •2.Patients with no history of allergy to articaine or other anesthetic compounds such as epinephrine
- •3.Patients do not take any drugs that affect pain perception on the day of treatment 4 hours prior, such as analgesic drugs, non-steroidal anti-inflammatory drugs (NSAIDs).
- •4.Cooperative pediatric patients (Frankl behavior rating scale 3 and 4) and can communicate
- •5.Patients and parents agree to participate in the study.
- •Tooth inclusion criteria
- •Pre-operative clinical inclusion criteria
- •1. Permanent maxillary first molar with deep carious lesion
- •2. Tooth responds positively to the sensibility test by cold test and diagnosed with normal pulp, initial pulpitis, mild pulpitis, moderate pulpitis or severe pulpitis.
- •3. Tooth has no signs of pulp necrosis such as clinical swelling, pus exudate, or fistula of soft and periodontal tissues
- •4. Tooth has no abnormal tooth mobility
- •Intra-operative clinical inclusion criteria
- •1. Both exposed and non-exposed teeth after non-selective caries removal are included.
- •2. In the case of pulpal exposed teeth, the pulp tissues must be vital judging by its bleeding and pulp tissue appearance
- •3. Pulpal bleeding must be controlled within 10 minutes.
- •Radiographic inclusion criteria
- •1. From bitewing radiographs, the carious lesion must be deeper than 3/4 of the dentin thickness.
- •2. From paralleled periapical radiographs, there are no prominent radiolucency at the furcation or periapical regions, internal root resorption, or pathologic external root resorption, and absence of calcification or pulp canal obliteration.
排除标准
- •Patient exclusion criteria
- •1. Patients with underlying diseases that are contraindicated for vital pulp therapy
- •2. Patients with history of allergy to articaine or other anesthetic compounds such as epinephrine
- •3. Patients take any drugs that affect pain perception on the day of treatment 4 hours prior
- •4. Patients who cannot distinguish the sensation of pulpal tissue proved by sham test
- •5. Uncooperative pediatric patients (Frankl behavior rating scale 1 and 2)
- •6. Patients and parents deny participation in the study.
- •Tooth exclusion criteria
- •Pre-operative clinical inclusion criteria
- •1. Tooth with clinically diagnosis of pulp necrosis
- •2. Tooth has no respond to the sensibility test by cold test
- •3. Tooth cannot be restored by a resin composite restoration or stainless-steel crown
- •4. Tooth with history of clinical swelling, pus exudate, or fistula of soft and periodontal tissues
- •5. Tooth that does not have soft or pulp tissue? anesthesia after 10 minutes following buccal infiltration
- •Intra-operative clinical inclusion criteria
- •6. Uncontrollable bleeding from exposure site for more than 10 minutes
- •7. Pale color of pulp tissue or absence of bleeding suggesting pulp necrosis
- •8. Pulpal bleeding with dark colored blood suggesting high pulpal inflammation rate
- •Radiographic exclusion criteria
- •1. Bitewing radiographs, the carious lesion is less than 3/4 of the dentin thickness.
- •2. Paralleled periapical radiograph, there are prominent radiolucency at the furcation or periapical regions, internal root resorption, pathologic external root resorption, calcification, or pulp canal obliteration.
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