One Year Clinical Performance of Self Adhesive Giomer Containing Flowable Composite in Restoring Class V Cavities: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 主要终点
- Assessing change in marginal discoloration between time points 3, 6 ,12 months
研究概览
简要总结
This clinical trial will be conducted to compare the clinical performance of self adhesive giomer containing flowable composite and putty nanohybrid resin composite in class V cavities over one year follow-up
详细描述
This clinical trial will be conducted in Department of Conservative Dentistry, Faculty of Dentistry,Cairo university outpatient clinic. The Operator in charge will be: Salma Mohamed Monir (S.M).
The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to the patients.
Screening of patients that come to the Conservative Dentistry Department Clinic seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, the patients will be contacted by the research investigator (S.M) who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made.
Randomization will be done using simple randomization by (N.K) by generating numbers from 1:100 into two columns according to interventions/Control assessment methods. The allocation sequence will be generated using (www.randomization.com) The randomization list will be kept with (N.K) and will be kept secured away to ensure no tampering with the random list. Each participant will choose a random number from an opaque sealed envelope. When the participant chooses an envelope, it will be signed by the patient and the supervisor and the number on the envelope will be recorded in the patient chart to ensure that the patient is assigned to the randomized group The assessors, statistician and the patients will be blinded to intervention/control assessment methods; Triple blinded study. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
For every patient medical and dental history will be taken. Examination charts will be filled by the investigator S.M.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The assessors, statistician and the patients will be blinded to intervention/control assessment methods; Triple blinded study. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with carious anterior or posterior buccal class V lesions.
- •No signs of irreversible pulpitis (vital teeth)
- •Young adult males or females.
- •. Acceptable oral hygiene.
- •Co-operative patients approving to participate in the study
排除标准
- •Patients with a compromised medical history.
- •Severe or active periodontal disease
- •Systemic diseases or severe medical complications (disabilities).
- •Lack of compliance
- •Extensive carious lesion that is in risk of pulp exposure.
- •Rampant caries.
- •History of pain or swelling.
- •Endodontically treated teeth.
- •Mobility grade 1 or 2
- •Non-carious cervical abfraction lesions
研究组 & 干预措施
class V cavities treated with putty nanohybrid resin composite
Selective enamel etching will be done and a universal adhesive (Prime&Bond universal™ ,Dentsply)will be applied to both enamel and dentin. After gentle dryness and solvent evaporation the bonding agent will be cured for 20 seconds. Composite (Neo Spectra™ST, Dentsply, Sirona, USA) will be placed incrementally and light cured for 20 seconds
干预措施: (Neo Spectra™ ST, Dentsply, Sirona, USA) (Other)
class V cavities treated with Self adhesive giomer containing nanohybrid flowable composite
Cleaning and gentle air blowing of the preparation. Then applying FIT SA F03 (Low Flow), SHOFU, USA. Spread in a thin layer (≤0.5mm) on the prepared surface with needle tip, microbrush and gently air-blow leave for 20 seconds then light cure for 5 seconds. Then,apply additional increments (≤2mm) of FIT SA and light cure each increment for 10 seconds then finish and polish
干预措施: (FIT SA F03, SHOFU, USA) (Other)
结局指标
主要结局
Assessing change in marginal discoloration between time points 3, 6 ,12 months
时间窗: 3,6,12 months
Visual inspection with mirror Alpha :There is no visual evidence of any marginal discoloration at the junction of the restoration and the adjacent tooth structure . Bravo :There is visual evidence of shallow marginal discoloration. Charlie : There is visual evidence of deep marginal discoloration toward a pulpal direction.
次要结局
- Assessing change in modified USPHS criteria between time points 3, 6 ,12 months(3,6,12 months)
研究者
Salma Mohamed Monir Mahmoud Ahmed
principal investigator
Cairo University