Effect of Graphene Oxide on Vital and Non-Vital Primary Teeth Compared to the Conventional Techniques: Randomized Multi-Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 主要终点
- Clinical success
研究概览
简要总结
The null hypothesis of the current study suggested that there will be no significant difference regarding the effect of Graphene Oxide (GO), Lesion sterilization and tissue repair (LSTR) and Zinc Oxide and Eugenol on the clinical and radiographic success rate of non-vital pulpotomy of primary teeth and that there will be no significant difference regarding the effect of Graphene Oxide (GO), MTA and Zinc Oxide and Eugenol on the clinical and radiographic success rate of vital pulpotomy of primary teeth.
The children (n=126) will be divided randomly into 2 arms; each arm has 3 groups, according to the type of pulp therapy dressing, medicament,t and technique of its application as follows:
First Arm (Vital Teeth) Group 1: will receive Graphene Oxide using the vital pulpotomy technique (study group, n=21) Group 2: will receive MTA using vital pulpotomy technique (study group, n=21) Group 3: will receive Zinc Oxide and Eugenol using the vital pulpotomy technique (control group, n=21) Second Arm (Non-Vital Teeth) Group A: will receive Graphene Oxide using the non-vital pulpotomy technique (study group, n=21).
Group B: will receive LSTR using the non-vital pulpotomy technique (study group, n=21).
Group C: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21).
Clinical and radiographic success will be assessed as primary outcomes, while pain, patient satisfaction,n and time of procedure will be assessed as secondary outcomes.
详细描述
This study will be designed as a multi-arm randomized clinical trial Statement of the Problem Pulpotomy is the most commonly attempted pulp therapy procedure to treat pulp exposures in primary teeth; however, challenging pulp therapy can end up in failure and subsequent premature loss of primary teeth, which may bring about disturbances like ectopic eruption, alteration in eruption sequence, space loss, development of deleterious habits, functional and speech impairment.
Sample Size calculation If there is truly no difference between the standard treatments and Graphene oxide (99% in both groups), then 17 patients are required to be 80% sure that the two-sided 90% confidence interval will exclude a difference between the standard and experimental groups of more than 10%. This number is to be increased to 21 to compensate for losses during follow-up (20% more than the calculated). Sample size was calculated by Sealed Envelope Ltd. 2012. Power calculator for a binary outcome equivalence trial Statistical Methods Data will be analysed using IBM SPSS Advanced Statistics (Statistical Package for Social Sciences), Version 27.0. (Armonk, NY: IBM Corp) Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Data will be explored for normality using Kolmogrov Smirnov test and Shapiro Wilk test.
Comparisons between two groups for normally distributed numeric variables will be done using the Student's t test, while for non-normally distributed numeric variables will be done by Mann Whitney test. Comparisons between categorical variables will be performed using the chi-square test. An equivalence limit will be tested in comparison between groups. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two-tailed. Julious SA. Estimating Sample Sizes in Clinical Trials. CRC; 2009.
Study Setting and Population This study will involve children aged between 5 and 10 years old with primary teeth indicated for pulp therapy at the dental outpatient clinic of the Pediatric Dentistry and Dental Public Health Department of Al Azhar University, Cairo Boys.
Subject grouping:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*Inclusion Criteria* (First Arm)
- •Cooperative child
- •Presence of symptom-free deep carious lesions
- •Presence of at least two-thirds of the root length radiographically; restorable tooth
- •(Second Arm)
- •Primary teeth diagnosed with pulp necrosis, root resorption equal to or less than one-third (with sufficient dental structure for absolute isolation with rubber dam)
- •History of spontaneous pain and mobility incompatible with chronological age, possibly with the presence of a sinus tract or swelling
- •Presence or absence of a radiolucent area in the periapical or furcation region
排除标准
- •* (First Arm)
- •History of systemic diseases
- •Teeth showing clinical and radiographical evidence of pulp degeneration, such as history of spontaneous or nocturnal pain, tenderness to percussion or palpation, pathologic mobility, swelling or fistulous tract, periodontal ligament (PDL) space widening, internal root resorption, external root resorption, furcal radiolucency/inter-radicular bone destruction, and/or periapical bone destruction
- •Teeth without a permanent successor
- •Teeth requiring more than 5 minutes to achieve hemostasis during the clinical procedure
- •(Second Arm)
- •Children with a history of allergic reaction to the components of the tested materials
- •Children had used antibiotics in the last three months.
- •Teeth with pulp canal obliteration or internal or external pathological root resorption visible in periapical radiographs
- •Coronal destruction that would prevent absolute isolation with a rubber dam and/or restoration
研究组 & 干预措施
Group 1: will receive Graphene Oxide using vital pulpotomy technique
Group 1: Vital Teeth will receive Graphene Oxide using vital pulpotomy technique (study group, n=21)
干预措施: Graphene Oxide using vital pulpotomy technique (Other)
Group 2: MTA using vital pulpotomy technique
Group 2: will receive MTA using vital pulpotomy technique (study group, n=21)
干预措施: MTA using vital pulpotomy technique (Other)
Group 3: will receive Zinc Oxide and Eugenol using vital pulpotomy technique (control group, n=21)
Group 3: will receive Zinc Oxide and Eugenol using vital pulpotomy technique (control group, n=21)
干预措施: Zinc Oxide and Eugenol using vital pulpotomy technique (Other)
Group a: will receive Graphene Oxide using non-vital pulpotomy technique (study group, n=21).
Group a: will receive Graphene Oxide using non-vital pulpotomy technique (study group, n=21).
干预措施: Graphene Oxide using non-vital pulpotomy technique (Other)
Group b: will receive LSTR using non-vital pulpotomy technique (study group, n=21).
Group b: will receive LSTR using non-vital pulpotomy technique (study group, n=21).
干预措施: LSTR using non-vital pulpotomy technique (Other)
Group c: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21)
Group c: will receive Zinc Oxide and Eugenol using non-vital pulpotomy (Control group, n=21).
干预措施: Zinc Oxide and Eugenol using non-vital pulpotomy (Other)
结局指标
主要结局
Clinical success
时间窗: Immediate Postoperative, 1 week, 3 months, 6 months and 12 months
Assessing mobility, normal functioning, sensitivity to percussion, gingival inflammation, periodontal pocket formation, and presence or absence of sinus tract according to a scoring system from (1) to (4) as follows: Score (1): Asymptomatic Pathology: absent Normal functioning Mobility: (physiological) ≤ 1mm Score (2): Slight Discomfort, short-lived Pathology: questionable Percussion sensitivity Gingival inflammation: (due to poor oral hygiene) Mobility: (physiological) ≤ 1mm Score (3): Minor discomfort, short-lived Pathology: initial changes present Gingival swelling: (not due to poor oral hygiene) Mobility: \> 2 mm but \< 3 mm Score (4): Major discomfort, long-lived. Extract immediately Pathology: Late changes present Spontaneous pain Gingival swelling: (not due to poor oral hygiene) Periodontal pocket formation (exudate) Sinus tract present Mobility: ≤ 3mm Premature tooth loss due to pathology
Radiographic success
时间窗: Immediate Postoperative, 3 months, 6 months and 12 months
Radiographic evaluation will be assessed using a scoring system from score (1) to (4) as follows: Score (1): No changes at 6 months follow-up\* Internal root canal tapering from the chamber to the apex Periodontal ligament \\ periapical regions; normal width and trabeculation Score (2): Questionable Pathological changes at 3 months follow-up\* No External changes (widened PDL), abnormal inter-radicular trabeculation, or variation in radiodensity Internal resorption is acceptable (not perforated) Calcific metamorphosis is acceptable Score (3): Pathological changes present at 1-month follow-up\* External changes are present, but not large Mildly widened PDL Minor inter-radicular radiolucency with trabeculation still present Minor external root resorption; internal resorption changes are acceptable, but not if external changes are also present (perforated form) Score (4): Pathological changes are present. Extract immediately Frank osseous radiolucency present
次要结局
- Presence or absence of pain(Immediate Postoperative)
- Patient satisfaction(Immediate Postoperative)
- Time of procedure(Immediate Postopertive)
研究者
MENNA HELAL
PHD Candidate, Pediatric Dentistry Department, Azhar University
Al-Azhar University