Keywords
Cention N, Class V restorations, Resin modified glass ionomer cement (RMGIC), Post-operative sensitivity, Microleakage.
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Cention N, Class V restorations, Resin modified glass ionomer cement (RMGIC), Post-operative sensitivity, Microleakage.
For an effective restorative material to reduce microleakage, excellent bonding of restoration with tooth surface is crucial. Poor adaptation can result in pulpal inflammation, secondary caries, bacterial penetration, postoperative sensitivity, marginal discoloration, and pulpal discoloration.1 A restoring material should not be bioincompatible and provide a durable tight seal against infection by bacteria to retain pulp vitality.2 For many years, amalgam has been the material of choice in clinical settings because of its excellent mechanical and financial characteristics. However, due to the toxicity of mercury and its unpleasant look, there have been concerns over the biocompatibility of amalgam.3,4 Due to their aesthetics, minimum tooth preparation requirements, and strong bonding capabilities to tooth structures, these drawbacks encourage further study and development of restorative materials, such as glass ionomers and composite resins.3 Wilson and Kent created glass ionomer cement (GIC) in 1972.5 The benefits of GIC include its capacity to attach to enamel and dentin, release fluoride continuously and stop cavities by creating a marginal seal.4 The mechanical properties of the new GIC, GC Fuji IX GP,6 have been improved, which may be advantageous for patients.6 GIC contains fluoride, binds to tooth structure without additional bonding agent, is strong enough, and may be polished and finished in a single appointment.6 Cention-N is one of the recently created materials that has grown in prominence.7 An “alkasite” restorative substance is cention-N. This new category makes use of an alkaline filler can release ions that can neutralize acids.7 In comparison to both amalgams and GIC, Cention-N, a novel filling material, offers these qualities in addition to additional benefits such as increases bond strength and decreasing micro leakage. It is a tooth-colored, dual-cured material that can be used to restore both class I, II, and V permanent restorations as well as deciduous teeth.7
This is an in vivo comparative study which will be conducted on the patents reporting to the sharad pawar dental college and hospital.
Inclusion criteria
Only those individuals who will be interested in undergoing the suggested treatment technique were included in the study, and enough time was allotted for the procedure to be adequately completed.
The patients must also meet the following:
• Patients must be more than 18 years.
• All maxillary and mandibular teeth included in this study have class V cavities.
• Teeth having cervical abrasion.
• Patients having cavity depth of at least 3mm.
Exclusion criteria
Patients will be excluded if they have: reversible or irreversible pulpitis, periodontitis and periapical conditions, who are on anti-inflammatory medications and painkillers, patients have allergies to the study's materials, especially resin, patients having para-functional activities (i.e. bruxism, tongue thrusting, clenching).
The preparation of class V cavity will be done under strict isolation due to gingival crevicular fluid (GCF) and saliva on the facial or buccal surface of the tooth having a depth not more than 3 millimeters, using a high-speed airotor (Allure airotor handpiece by prime dental) with water cooling. Teeth having cervical abrasions will cleaned with the help of water using a three-way syringe. Both the materials (Cention-N and RMGIC) comes in powder and liquid form, powder and liquid will be taken on the mixing pad and liquid is mixed with powder. After achieving a restorative consistency the material will be placed into the cavity using cement carrier (API Dental carrier). Materials will be condensed into the cavity. Excess material is removed with the help of carver (API dental carver). Patients will recalled after seven days for evaluation. The Schiff Scale (SS) will be used to evaluate post-operative sensitivity.
Single blinding will be used in this study. Using patient's stimulus-response, this scale assesses the level of dental hypersensitivity pain.8 The individual receives a score between 0 and 3 on the SS.8 The score is assessed by the operator. The scoring criteria and interpretation are as follows.
Scoring criteria8
0: No response
1: The patient reacts to the stimuli, they do not ask for it to stop.
2: Responding to the stimuli, patient either asks for it to stop or moves away.
3: The patient reacts to the stimuli, experiences it as painful, and asks for it to stop.
Expected outcomes
We expect that teeth restored with recently advanced restorative material Cention-N are likely to be more susceptible to microleakage and reduce post-operative dentinal hypersensitivity. It is also likely that class V patients' postoperative sensitivity may be affected by the restorative material used and their method sensitivity.
Sample size
This formula9 helps to derive the sample size.
Where,
Z1 − α/2 confidence interval of 95% (as per reference article)
Confidence interval Z1 = 1.96 (as per reference article)
Ζβ is the critical value of normal distribution at β = 0.95 (as per reference article)
d = difference to be detected, 1.0-0.1 = 0.9 (as per reference article)
σ, population standard deviation, SD1 = 0.37, SD2 = 0.48 (as per reference article)
Total sample size: 36
With the above-mentioned calculation, the sample size determination of both the groups is 18 in RMGIC group and 18 in Cention-N group. The total minimum sample size with 95% of the confidence interval. The total sample size was calculated to be 36, i.e. 18 in RMGIC group and 18 in Cention-N group. The first 18 patients who are enrolled in this study will be included in the Cention-N group and the second 18 enrolled will be in the RMGIC group.
Statistical method
Data will be collected using Schiff Scale (SS) and paired t test will be done and data will be collected using Microsoft Excel (RRID:SCR_016137). Statistical analysis will be carried out using SPSS 23 Software (RRID:SCR_002865).
Dissemination
In this study we will be comparing the resistance to post-operative sensitivity and microleakage resistance after restoration with the two groups of restorative materials one is Cention-N and the other one is Resin modified glass ionomer cement (RMGIC). The alternative restorative material Cention-N is an excellent choice since it has promising mechanical characteristics (good bond strength in comparison with RMGIC) and minimal microleakage. As Cention-N is aesthetically pleasing and takes less chairside time it can be used as alternative restorative materials in class V cavities.
Study status
The study is not started yet. This trial protocol is not registered.
In this study the expected postoperative sensitivity after restoration with a newer material which is Cention-N will be lesser as compare the conventional restorative material resin modified glass ionomer cement (RMGIC), According to multiple study literature Cention-N has less microleakage properties as compared to RMGIC so it will show less postoperative dentinal sensitivity. The expected chai side time will also be less in case of Cention-N as compared to RMGIC.
In class V cavities filled with the Cention-N which is a recent alkasite material, with and without the use of a bonding agent and flowable composite resin, Priyatama Meshram et al, examined microleakage at the enamel restoration and dentin restoration interface and concluded that each group's microleakage at the enamel-dentin repair interface was lower than the others, but the difference was not statistically significant.10 The Cention-N with adhesive had the least micro leakage, which was followed by flowable composite. When Cention-N was used without adhesive, more microleakage was observed.10
Pratima R Shenoi et al evaluated and compared marginal microleakage in the teeth in which restoration is done with flowable composite and Cention-N, Class V cavities. They concluded that Cention-N displayed reduced microleakage when compared to flowable composite, which was statistically significant (P = 0.005). In comparison to flowable composite, Cention-N demonstrated noticeably less leakage and improved adaptability.11
Sujith et al have done a study to differentiate between the physical characteristics and microleakage of Cention-N in relation to glass ionomer cement (GIC) and hybrid composite restorative materials. They observed that Cention-N had slightly lower compressive and flexural strength than glass ionomer cement (GIC), but comparable strength to hybrid composites.12
• The research proposal has been approved by the Institutional Ethics Committee of data meghe institute of higher education and Research, sawangi meghe, Wardha. Ref. No- DMIHER (DU)/IEC/2023/720.
• Informed written consent for the procedure will be obtained from all the participants and they are informed about the whole procedure.
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Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Not applicable
References
1. Mazumdar P, Das A, Das UK: Comparative evaluation of microleakage of three different direct restorative materials (silver amalgam, glass ionomer cement, cention N), in Class II restorations using stereomicroscope: An in vitro study.Indian J Dent Res. 2019; 30 (2): 277-281 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Biomaterials, endodontic microbiology, root canal disinfection
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Version 1 23 Aug 23 |
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