EFFECT of USE of DIODE LASER and 3% NaOCl for HEMOSTASIS in DIRECT PULP CAPPING on OUTCOME in MILD and MODERATE PULPITS:A PROSPECTIVE CLINICAL STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 1.Clinical success rate
研究概览
简要总结
Goal of this prospective clinical study is evaluate the effect of use of diode laser and 3% NaOCl for hemostasis in direct pulp capping on outcome in mild and moderate pulpitis Population includes systemically healthy patient of age 18-45 years with extremely deep carious lesion in mandibular molar with normal periapical structure exibiting symptoms of mild and moderate pulpits .Clinical outcome assessed at 1 week and 3month by using electric pulp testing and cold test radiographic outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period.
详细描述
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion, vital pulp therapy procedures in the form of direct pulp capping is more conservative treatment strategy. When applied to dental tissues lasers have shown their potential to increase healing, control hemorrhage, stimulate dentinogenesis and preserve vitality of the dental pulp. Laser amplifies the healing process by stimulation of cell regeneration and is capable of inducing the odontoblasts for laying down tertiary dentine and forming a dentine bridge. Diode laser has great penetration, eliminate microorganism and has been shown to reduce post operative pain (Genc Sen, O.et al).Iraj Yazdanfar et al. evaluated the efficiency of diode 808-nm laser combined with Theracal LC in direct pulp capping performed on the caries-exposed pulps of permanent teeth and radiographically compared the thickness of dentin bridge formed for a 6-month follow-up. They found favorable results but recommended further studies with larger sample sizes, longer follow-up periods, and different capping material are needed to prove the effectiveness of the diode laser.
AIM & OBJECTIVES- To evaluate the effect of use of diode laser and 3% NaOCl for hemostasis in Direct Pulp Capping in mild and moderate pulpitis on success and survival.
Primary objective-To determine the success rate and survival of diode laser and sodium hypoclorite as hemostatic agent in direct pulp capping with biodentine, based on clinical findings at 1week,3 months and both clinical and radiographic findings at 6 and 12 months.Secondary objective-To assess the post operative pain from Day 1 to Day 7 post treatment(NRS score).
Participants:
Inclusion Criteria: -Healthy patients (ASA I ).Patients falling in the age group of 18-45 years.Unrestored Permanent mandibular posterior teeth.Extremely deep caries are defined as radiographic evidence of caries penetrating the entire thickness of the dentine with certain pulp exposure. In extremely deep lesions, the demineralized process extends the entire thickness of the dentine. (L.BJORNDAL et al.2019)Only occlusal pulp exposure due to caries.Vital teeth with signs and symptoms of mild and moderate pulpitis- Mild pulpitis Heightened and lengthened reaction to cold, warmth and sweet stimuli that can last up to 20 s but then subsides, possibly percussion sensitive. According to the histological situation that fits these findings, it would be implied that there is limited local inflammation confined to the crown pulp (W. J. Wolters et al.) Moderate pulpitis- Clear symptoms, strong, heightened and prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain that can be more or less suppressed with pain medication According to the histological situation that fits these findings, it would be implied that there is extensive local inflammation confined to the crown pulp (W. J. Wolters et al.).Exposure size 0.5 to 1 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Healthy patients (ASA I ).2.Patients in the age group of 18-45 years.Unrestored permanent mandibular posterior teeth.3.Extremely deep caries defined as radiographic evidence of caries penetrating the entire thickness of the dentine with certain pulp exposure. In extremely deep lesions, the demineralized process extends the entire thickness of the dentine, which perhaps excludes these cases from selective caries removal and a strategy based on avoiding pulp exposure. (l.bjorndal et al.2019).4.Vital tooth with signs and symptoms of mild and moderate pulpitis .Mild pulpitis Heightened and lengthened reaction to cold, warmth and sweet stimuli that can last up to 20 s but then subsides, possibly percussion sensitive. According to the histological situation that fits these findings, it would be implied that there is limited local inflammation confined to the crown pulp (W. J. Wolters et al.).Moderate pulpitis Clear symptoms, strong, heightened and prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain that can be more or less suppressed with pain medication. According to the histological situation that fits these findings, it would be implied that there is extensive local inflammation confined to the crown pulp.5.Occlusal pulp exposure because of caries removal.6.Exposure size upto 0.5 to 1 mm
排除标准
- •1.No pulp exposure after caries excavation.2.No bleeding after pulp exposure.3.The presence of a previous restoration of the tooth.4.Participants who not signed the written consent form.5.Patient with PAI score >
- •6.Severe pulpits-There are any clinical symptoms of Severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, patients have trouble sleeping because of the pain (gets worse when lying down).7.Tooth is very sensitive to touch and percussion.
- •8.Evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.9.Patients with periodontal disease, swelling and sinus tract.10.A positive history of antibiotic use within 1 month and analgesic use within week before the treatment.
研究组 & 干预措施
3% NaOCl
after pulp exposure bleeding was control by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound upto 1 minutes.If hemostasis was not achieve with in 1mins we again use soaked cotton pellet of 3% NaOCL for another 1 mint until the hemostasis acheived. Tooth with excessive uncontrollable bleeding even after 5 mins was excluded from the study
干预措施: hemostasis with 3% NaOCl in direct pulp capping (Procedure)
3% NaOCl
after pulp exposure bleeding was control by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound upto 1 minutes.If hemostasis was not achieve with in 1mins we again use soaked cotton pellet of 3% NaOCL for another 1 mint until the hemostasis acheived. Tooth with excessive uncontrollable bleeding even after 5 mins was excluded from the study
干预措施: hemostasis with diode laser in direct pulp capping (Procedure)
diode laser
Hemostasis was achieved by exposure to Primo dental diode laser by medency (980 nm), at 0.5 W(medency Primo laser) .During laser application patients, operator and assistant were asked to wear protective eye shields.The laser energy of wavelength 980 nm introduced to the exposure site through a 400 µm optical fiber in a non contact mode for 2-3 seconds at exposure site for three times at 10s time interval to achieve complete hemostasis.For disinfection same diode laser of wavelength 980nm with energy set at 1W used in non contact mode in circular motion in the cavity
干预措施: hemostasis with 3% NaOCl in direct pulp capping (Procedure)
diode laser
Hemostasis was achieved by exposure to Primo dental diode laser by medency (980 nm), at 0.5 W(medency Primo laser) .During laser application patients, operator and assistant were asked to wear protective eye shields.The laser energy of wavelength 980 nm introduced to the exposure site through a 400 µm optical fiber in a non contact mode for 2-3 seconds at exposure site for three times at 10s time interval to achieve complete hemostasis.For disinfection same diode laser of wavelength 980nm with energy set at 1W used in non contact mode in circular motion in the cavity
干预措施: hemostasis with diode laser in direct pulp capping (Procedure)
结局指标
主要结局
1.Clinical success rate
时间窗: [ baseline to 12 months]
Clinical criteria of success:- 1.No pain or discomfort except for the first few days after treatment. 2.No tenderness to palpation or percussion and the tooth is functional. 3.Normal mobility and probing pocket depth. 4.Healthy soft tissues around teeth with no swelling, sinus tract.
2.Radiographic success rate
时间窗: [Time Frame: baseline to 12 months]
Radiographic success criteria:- 1.No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2.Complete radiographic healing
次要结局
- 3. Post Operative Pain([Time Frame: Baseline to 7 days]])