A preliminary study to evaluate the outcome of combination of non-surgical endodontic and vital pulp therapy for management of mature permanent molar teeth with symptomatic irreversible pulpitis and periapical rarefaction.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the clinical and radiographic periapical healing in mature permanent molar teeth with symptomatic irreversible pulpitis and periapical rarefaction after the following treatment procedures:
研究概览
简要总结
Evidence shows that at any given moment in a toothmany different stages of disease process can be observed throughout the pulp. Specially for multi-rooted teeth, the clinical scenario becomes morecomplex where one root shows periapical involvement while other root does notshow periapical involvement. It can be interpreted that there is a high chanceof pulp degeneration or necrosis in the root with periapical involvement whichshould be treated by conventional non-surgical endodontic therapy (NSET) and theroot with vital pulp and no periapical involvement should be given a chance toregenerate with vital pulp therapy (VPT). On these basis, atreatment protocol of a combination of NSET and VPT is proposed for molar teethwith symptomatic irreversible pulpitis and periapical rarefaction in either ofroots. This treatment modality will remove the diseased part and help inpreservation of healthy tissue, also maintain the vitality of the radicularpulp and help in preservation of immunological functions and retainingstructural integrity of the tooth.
Two groups (Group I and Group II) will be defined on thebasis of the procedure done in molar teeth with symptomatic irreversible pulpitis and periapicalrarefaction in either of roots. A block randomization with variableblock size will be used to generate sequence of random number for allocation ofteeth to one of the two groups. Each random number will be kept in an opaqueenvelop which would be opened at the time of allocation of teeth in one of thetwo group. The subjects will be blinded throughout the study. Sixty teeth willbe distributed into the pre-determined study groups as follows:
Group-I: Non-Surgical Endodontic Therapy
Group- II: Combination of Non-Surgical Endodontics andVital Pulp Therapy
The teeth will be evaluatedclinically and radiographically. The patient will be reviewed after every 6months for the study period. The review radiographs will be taken at 6-monthand 12-month interval. Tenderness to palpation, percussion, presence ofswelling and the absence/presence of sinus will be assessed. Appropriatestatistical test would be applied to the data generated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy patient of either gender between 18-35 years of age group.
- •Mandibular molar teeth with definitive clinical diagnosis of irreversible pulpitis with periapical involvement (PAI score ≥ 3) in either of the roots.
- •Positive response to cold and EPT testing.
- •The tooth is restorable.
- •Probing pocket depth and mobility are within normal limits.
排除标准
- •Teeth with definitive clinical diagnosis of Irreversible Pulpitis which are not associated with periapical rarefaction.
- •Intraoperative exclusion criteria: 1)Bleeding cannot be controlled within 6 mins with pressure pack.
- •Clinical diagnosis changes from symptomatic irreversible pulpitis to pulp necrosis.
结局指标
主要结局
To compare the clinical and radiographic periapical healing in mature permanent molar teeth with symptomatic irreversible pulpitis and periapical rarefaction after the following treatment procedures:
时间窗: 6 months, 12 months
a.Non-surgical endodontic therapy
时间窗: 6 months, 12 months
b.Combination of non-surgical endodontic and vital pulp therapy
时间窗: 6 months, 12 months
次要结局
- No secondary outcome measurement(Not applicable)