Comparative Clinical and Radiographic Evaluation of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
This randomized clinical trial aims to evaluation the clinical and radiographic outcomes of hyaluronic acid, TheraCal, and Mineral Trioxide Aggregate (MTA) when used as pulpotomy agents in primary molars.
The main question it aims to answer is:
In children with restorable mandibular second primary molars requiring pulpotomy, does the use of hyaluronic acid or TheraCal LC, compared to MTA, result in improved clinical and radiographic success rates over a 12-month follow-up period?
详细描述
Premature loss of primary teeth can affect occlusion development and lead to complications such as space loss and malalignment of permanent teeth. To prevent this, effective pulpotomy treatment is essential. Therefore, identifying the most suitable pulpotomy agent is crucial to retain primary teeth until their natural exfoliation.
According to MTA research, it has a high success rate as a pulpotomy agent and favors tissue regeneration while also having a good long-term prognosis, good biocompatibility, and strong sealing capacity . Among its many applications are direct pulp capping, pulpotomy, root end filling, apexification, apexogenesis, and root perforation . Low compressive strength, high pH (approximately 10.2 after setting which take 3 hours, pH increase to 12,5), high cost, short shelf life, manipulation challenges, lengthy setting time, and discoloration are some disadvantages.
TheraCal LC (Bisco, Schaumburg, IL, USA) is a novel calcium silicate-based resin-modified material designed as a liner under restorative materials to protect and stimulate the pulp in both direct and indirect pulp capping. It contains polyethylene-glycol dimethacrylate monomers, barium zirconate, and tri-calcium silicate particles. According to earlier research, the TheraCal LC material stimulated the production of secondary dentin and apatite by releasing calcium.
TheraCal provides a number of advantages over other silicate-based materials, including low solubility, easy application, good mechanical properties, setting time, adequate bonding ability, and prevention of microleakage. Commercially available as a syringe, TheraCal is user-friendly. TheraCal is a good option for kids who can't handle long visits and might eventually stop cooperating because of all these benefits.
Hyaluronic Acid (HA) is made up of polyanionic disaccharide units of N-acetyl glucosamine and glucuronic acid joined by alternating β-(1ــــ3) and β-(1ــــ4) linkages. It is a naturally occurring non-sulfated glycosaminoglycan with a high molecular weight of 4000-20,000,000 Da. It is a linear polysaccharide found in the extracellular matrix of skin, vitreous humor, embryonic mesenchyme, connective tissue, synovial fluid, and several other human tissues and organs . It is an appealing material for use in several dental operations due to its biocompatibility, regenerative qualities, and antibacterial properties .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Operator Blinding: The operator performing the procedure will not be blinded due to the differences in handling and appearance of the materials.
Patient and Parent Blinding: Participants and their parents/legal guardians will be blinded to the type of pulpotomy agent used. All materials will be applied under rubber dam isolation, and the clinical procedure will be standardized to avoid revealing the material identity.
Outcome Assessor Blinding: The clinical and radiographic evaluations will be performed by a blinded, calibrated examiner who is unaware of the group assignments. The radiographs will be coded and assessed using standardized criteria to prevent bias.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-8 years,
- •Co-operative patient
- •At least one restorable mandibular second primary molars with deep carious lesions requiring pulpotomy.
- •Absence of gingival swelling or sinus tract.
- •Absence of spontaneous pain.
- •Absence of pain on percussion.
- •Controlled bleeding.
- •First treatment the tooth.
- •Possibility of restoring the tooth with a stainless steel crown.
- •No Radiographic evidence of changes associated with pulp degeneration, such as widening of PDL space, internal root resorption, external root resorption, inter-radicular or periapical bone destruction (radiolucency).
排除标准
- •Swelling, sinus tract, or fistula.
- •Spontaneous pain.
- •Necrotic pulp, pathological mobility.
- •Cases require for general anesthesia.
- •A history of repeated need for analgesics.
- •Patients with any systemic diseases.
- •Uncontrolled bleeding.
- •Selected deciduous teeth without a permanent successor
研究组 & 干预措施
Hyaluronic acid
• After achieving complete hemostasis: Mix HA (0,5% gengigel teething) with ZO powder until a mixture, then apply it on pulp stumps.
all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India).
干预措施: Hyaluronic Acid (HA) (Procedure)
TheraCal
• After achieving complete hemostasis: TheraCal L.C will be applied directly to the radicular pulp by a disposable syringe tip and light cure will be done for 20 seconds.
all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India).
干预措施: TheraCal (Procedure)
Mineral Trioxide Aggregate
• After achieving complete hemostasis: mix MTA with sterile saline and put on pulp stumps. A moist cotton pellet was placed for initial setting.
all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India).
干预措施: Mineral Trioxide Aggregate (Procedure)
结局指标
主要结局
Clinical evaluation
时间窗: 3, 6, and 12 months.
Clinical evaluation: Absence of * Pain * Soft tissue swelling * Sinus tract * tenderness to percussion * tooth mobility
Radiographic evaluation
时间窗: 3, 6, and 12 months
Conventional radiographic evaluation: absence of * Internal resorption. * External resorption. * Periapical or furcation RL. * Obliteration pulp calcification. * Widening of periodontal space.
次要结局
未报告次要终点
研究者
Omaima Salah Ahmed Mohamed Elbeltagy
Doctor
Al-Azhar University