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Clinical outcomes of bioactive restorative materials in class Il restored primary molar: Randomized clinical trial

Clinical outcomes of bioactive restorative materials in class Il restored primary molar: Randomized clinical trial

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240723002
Enrollment
65
Registered
2024-07-23
Start date
2024-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental caries, proximal caries in primary tooth Class II restoration, Primary tooth, Bioactive restorative material, Glass ionomer cement

Interventions

Cention N, developed by Ivoclar Vivadent in the USA, marks a significant advancement in the spectrum of tooth-colored materials available for restorative dentistry. Classified as an alkasite, Cention
s long-term clinical performance, biocompatibility, and potential to act as a permanent restorative solution, with findings supporting its use as a versatile and durable restorative material. EQUIA Fo
s formulation, combining glass ionomer technology with composite resin principles, positions it as an advanced glass hybrid system poised to meet the diverse needs of modern dentistry. It is comprised
Experimental Other,Experimental Other
Cention N,Equia Forte

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: Age range: Participants are between 4 and 8 years old. Health Status: Children with an American Society of Anesthesiologists (ASA) score of I, indicating good health. Behavioral Assessment: A minimum rating of 3 on the Frankl scale, suggesting the child is likely to be cooperative. Dental Condition: Presence of two proximal caries in primary molars involved dentin with similar size and shape in contralateral teeth without signs of pulp necrosis, with proximal and occlusal contact. If the patient has cavity at adjacent proximal contact, the cavity must be restored with composite resin prior to the experiment, randomized by computed random number generator (0,1) Caries Evaluation: Class II cavities with an International Caries Detection and Assessment System (ICDAS) score 4-5, indicating visible dentin in a distinct cavity. With RA2 - RB4 ICCMS radiographic evaluation Radiographic Criteria: The study includes teeth expected to naturally exfoliate in no less than two years, with radiolucency extending from proximal area to middle 1/3 of dentin or distinct loss of enamel surface from inner half of enamel to outer 1/3 of dentin (RA2 - RB4 ICCMS radiographic evaluation) Absence of Pain and Infection: No spontaneous pain, no signs of infection such as fistulae, abscesses, swelling, or pain upon percussion. Caries Risk: Participants identified as having a high to extremely high risk of caries.

Exclusion criteria

Exclusion criteria: Systemic Health Conditions: Participants with systemic pathologies that could affect overall patient health are excluded. Dental Anomalies: Any cases of teeth with developmental irregularities, including discoloration, atypical anatomy or shape, and excessive mobility, are not included. Pulp Exposure: Teeth showing dental pulp exposure that necessitates either extraction or root canal treatment are also excluded from the study. Dental Condition: Cavity extending above line angle after preparation or cavity at mesial of first primary molar (D)

Design outcomes

Primary

MeasureTime frame
Physical properties 0,6,12 months FDI criteria

Secondary

MeasureTime frame
biological properties 0,6,12 months FDI criteria

Countries

Thailand

Contacts

Public ContactJaranawan Kongchantuk

Chulalongkorn University

jaranawan@gmail.com0823567666

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026