Clinical trial NCT06195449: Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement
Official title: Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement in Restoration of Primary Molars: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Decay
Keywords: Alkasite restorative material
cention N
GIC
Primary molars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical and radiographic performance of Alkasite restorative material versus glass ionomer in restoration of primary molars.

Detailed description: Restorations replacements are mostly caused by the existence of caries lesions surrounding the restorations, which are commonly referred to as secondary caries .

Secondary or recurrent caries is characterized as "lesions that occur at the edges of previously placed dental restorations" or "caries that develop in association with dental restorations or sealants" (CARS).Proper seal at the tooth surface restoration interface is essential . That's why the most frequently material used is (GIC) with the advantage of chemical adhesion to tooth structure, superior esthetics, and long-term fluoride release providing cariostatic effect, but it has the disadvantage of slow setting rate, low fracture toughness, susceptibility to moisture contamination, dehydration during initial phase of setting, and poor wear resistance.

Resin Modified Glass Ionomer and Composite have always been the preferred material for restoration although several modifications have been made recently to improve its properties, Cent ion N is one of the recent ones.

Cent ion N is a tooth-colored basic filling material for direct restoration. It belongs to the material of Alka sites, with high flexural strength. It also has calcium and fluoride releasing properties comparable to conventional GIC, besides it is quick and easy to use.

Eligibility criteria: Inclusion Criteria:

* 1. Children having carious primary molars without pulp exposure and normal radiograph.

  2. Children between age 5 and 7 years. 3. Both male and female are included. 4. Cooperative Children.

Exclusion Criteria:

* 1. Patients with systemic diseases. 2. Parent refuse to participate.

Primary outcomes:
measure: recurrent caries of the tooth
timeFrame: 12 months
Secondary outcomes:
measure: Color match of the restoration
timeFrame: 12 months
measure: Marginal Discoloration of the tooth
timeFrame: 12 months
measure: Marginal Adaptation of the tooth
timeFrame: 12 months
measure: Anatomic Form of the tooth
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: cairo university faculty of pediatric dentistry
name: Sherien Ezz Eldin, Professor
role: STUDY_DIRECTOR
References:
citation: Sharma H, Suprabha BS, Shenoy R, Rao A, Kotian H. Clinical effectiveness of alkasite versus nanofilled resin composite in the restoration of occlusal carious lesions in permanent molar teeth of children: a randomized clinical trial. Eur Arch Paediatr Dent. 2023 Jun;24(3):301-311. doi: 10.1007/s40368-023-00788-0. Epub 2023 Mar 22.
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citation: 8. Attia, R., et al., Clinical Performance of Alkasite Dental Material and High Viscosity Glass Ionomer Restorations in Class I Cavities. Comparative Study for One Year Follow Up. Egyptian Dental Journal, 2022. 68(4): p. 3881-3894.
citation: Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21.
citation: Mushtaq U, Mushtaq F, Thakur D, Rathee K, Poonia N, Khullar S. Comparative Evaluation of Postoperative Sensitivity Following Restoration of Class I Lesions with Different Restorative Materials: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):650-654.
citation: 5. Minocha, A., et al., Comparative evaluation of Cention N and Amalgam in Class II posterior restorations. UNIVERSITY JOURNAL OF DENTAL SCIENCES, 2021. 7(1).
citation: 4. Roulet, J., et al., In vitro wear of two bioactive composites and a glass ionomer cement. DZZ International, 2019. 1(1): p. 24-30.
citation: 3. Dodiya, P.V., et al., Clinical evaluation of cention-n and nano hybrid composite resin as a restoration of noncarious cervical lesion. J Dent Specialities, 2019. 7(1): p. 3-5.
citation: 2. Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration. 1995.
citation: 1. Class, V., Comparative evaluation of microleakage of three different restorative materials (Cention N, Zirconomer improved and Glass hybrid restorative system) in Class V cavity restoration using stereomicroscope: In vitro study.