Clinical and Radiographic Assessment of First Permanent Molars With Cention-N

NCT07703176 | Recruiting DMC

• 1 other identifier: Cention-N, Clinical Assessment
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

: Assessment of Clinical, Radiographic, and Oral Health-Related Quality of Life Following Restoration of First Permanent Molars with Cention N: A 12-Month Split-Mouth Randomized Controlled Trial Introduction Dental caries is one of the most common chronic diseases affecting children. First permanent molars (FPMs) are particularly susceptible to caries because of their early eruption and complex occlusal anatomy. Restorative treatment aims to preserve tooth function and prevent disease progression. Composite resin is widely used because of its esthetics and mechanical properties; however, polymerization shrinkage may compromise marginal integrity. Cention N is a newer alkasite restorative material that releases fluoride, calcium, and hydroxide ions, promoting remineralization and enhancing caries resistance. Since treatment success should include both clinical outcomes and patient-centered outcomes, oral health-related quality of life (OHRQoL) will also be assessed. Aim To compare the clinical and radiographic performance of Cention N and bioactive injectable resin composite in restoring first permanent molars over 12 months. A secondary objective is to evaluate changes in children's oral health-related quality of life. Materials and Methods This will be a split-mouth randomized controlled clinical trial involving 100 children aged 8-10 years. Inclusion criteria: Healthy children (ASA I or II). Positive/definitely positive behavior (Frankl 3 or 4). Bilateral carious first permanent molars. Vital, asymptomatic teeth without radiographic pathology. Exclusion criteria: Lack of parental consent. ASA III or higher. Teeth with signs of irreversible pulp disease or radiographic pathology. Ethical approval will be obtained from the Research Ethics Committee, Faculty of Dentistry, Minia University, and written informed consent will be obtained from parents. Clinical Procedure Following clinical and radiographic examination, local anesthesia and rubber dam isolation will be performed. Caries will be removed conservatively, followed by acid etching and adhesive application. One molar will be restored with bioactive injectable resin composite according to the manufacturer's instructions. The contralateral molar will be restored with Cention N, mixed and placed according to the manufacturer's instructions, with optional light curing. All restorations will be finished and polished using standardized procedures. Outcome Assessment Primary outcome Clinical and radiographic evaluation at 3, 6, and 12 months using the modified USPHS criteria, including: Color match Marginal adaptation Marginal discoloration Anatomic form Secondary caries Restoration integrity Secondary outcome Assessment of oral health-related quality of life using the Child Perceptions Questionnaire (CPQ8-10), which evaluates oral symptoms, functional limitations, emotional well-being, and social well-being. Statistical Analysis Collected data will be tabulated and analyzed using appropriate statistical methods to compare the performance of both restorative materials over the follow-up period.

Conditions

Dental Caries

Keywords

Cention N Clinical Trial

Outcome Measures

Primary Outcomes (6)

• Color Match (CM)

  Degree of shade harmony between restoration and natural tooth measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)

  "3,6,12 months"

• Marginal Adaptation (MA)

  Accuracy of the fit between restoration margins and tooth measured according the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)

  "3,6,12 months"

• Marginal Discoloration (MD)

  Presence of staining along the restoration-tooth interface measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)

  "3,6,12 months"

• Anatomic Form (AF)

  Ability of the restoration to reproduce natural tooth contour measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)

  "3,6,12 months"

• Secondary Caries (SC)

  Development of caries adjacent to the restoration measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)

  "3,6,12 months"

• Restoration Integrity (RI)

  Overall stability, wear resistance, and surface quality of the restoration measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)

  "3,6,12 months"

Secondary Outcomes (1)

• Oral Health Related Quality of Life

  1 year

Study Arms (2)

Cention N

EXPERIMENTAL

Following local anesthesia, rubber dam isolation, caries removal, and cavity preparation, enamel etching and adhesive application were performed, Cention N was hand-mixed according to the manufacturer's instructions (1 scoop powder:1 drop liquid), placed into the prepared cavity, adapted to the cavity walls, and condensed to ensure optimal marginal adaptation. Optional light curing for 20 seconds was performed, followed by finishing and polishing to obtain the final restoration.

Device: Cention-N

Resin Composite

ACTIVE COMPARATOR

Following local anesthesia and rubber dam isolation, caries removal and cavity preparation were performed using a high-speed diamond bur under water cooling. Enamel margins were etched with 37% phosphoric acid for 30 seconds, rinsed, gently air-dried, and an adhesive system was applied and light-cured according to the manufacturer's instructions. The cavity was then restored with a bioactive injectable resin composite placed directly into the cavity and light-cured for 20 seconds. Finishing and polishing procedures were performed to achieve proper anatomical contour and smooth surface

Device: Resin Composite

Interventions

Cention-N DEVICE

Following local anesthesia, rubber dam isolation, caries removal, and cavity preparation, enamel etching and adhesive application were performed. Cention N was hand-mixed according to the manufacturer's instructions (1 scoop powder:1 drop liquid), placed into the prepared cavity, adapted to the cavity walls, and condensed to ensure optimal marginal adaptation. Optional light curing for 20 seconds was performed, followed by finishing and polishing to obtain the final restoration.

Cention N

Resin Composite DEVICE

Following local anesthesia and rubber dam isolation, caries removal and cavity preparation were performed using a high-speed diamond bur under water cooling. Enamel margins were etched with 37% phosphoric acid for 30 seconds, rinsed, gently air-dried, and an adhesive system was applied and light-cured according to the manufacturer's instructions. The cavity was then restored with a bioactive injectable resin composite placed directly into the cavity and light-cured for 20 seconds. Finishing and polishing procedures were performed to achieve proper anatomical contour and smooth surface.

Resin Composite

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical:
• Children aged 8-10 years.
• Children classified as ASA physical status I or II.
• Children demonstrate positive or definitely positive behavior (scores 3 or 4 on the Frankl Behavior Rating Scale).
• Children who are available for regular recall visits throughout the study period.
• Presence of bilateral carious lesions in permanent first molars, with a clear description of lesion depth whenever possible.
• Asymptomatic vital permanent first molars showing no clinical or radiographic signs of pathology.
• Radiographic:
• Normal lamina dura and periodontal ligament space.
• No apical radiolucency.

You may not qualify if:

• Clinical:
• Children with behavioral difficulties or without signed parental consent.
• Children are classified as ASA physical status class III or higher.
• Teeth presenting clinical signs of pulpitis or necrosis (e.g., nocturnal pain, fistula, abscess, pulp exposure, or pathological mobility).
• Radiographic:
• Evidence of abnormal radiolucency involving the pulp chamber or root apex.
• Detection of furcal bone radiolucency or abnormal root resorption.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Dentistry, Minya university

Minya, Asyut Governorate, Egypt

RECRUITING

Related Publications (12)

• Zhu F, Chen Y, Yu Y, Xie Y, Zhu H, Wang H. Caries prevalence of the first permanent molars in 6-8 years old children. PLoS One. 2021 Jan 13;16(1):e0245345. doi: 10.1371/journal.pone.0245345. eCollection 2021.

  PMID: 33439883 BACKGROUND

• Selwitz RH, Ismail AI, Pitts NB. Dental caries. Lancet. 2007 Jan 6;369(9555):51-9. doi: 10.1016/S0140-6736(07)60031-2.

  PMID: 17208642 BACKGROUND

• Pizzolotto L, Moraes RR. Resin Composites in Posterior Teeth: Clinical Performance and Direct Restorative Techniques. Dent J (Basel). 2022 Nov 27;10(12):222. doi: 10.3390/dj10120222.

  PMID: 36547038 BACKGROUND

• Manhart J, Garcia-Godoy F, Hickel R. Direct posterior restorations: clinical results and new developments. Dent Clin North Am. 2002 Apr;46(2):303-39. doi: 10.1016/s0011-8532(01)00010-6.

  PMID: 12014036 BACKGROUND

• Hadzipasic-Nazdrajic A. Validation of the child perceptions questionnaire 8-10 in bosnia and herzegovina. Mater Sociomed. 2012;24(3):157-61. doi: 10.5455/msm.2012.24.157-161.

  PMID: 23922523 BACKGROUND

• Chan, K. H. S., Mai, Y., Kim, H., Tong, K. C. T., Ng, D., & Hsiao, J. C. M. (2010). Review: Resin Composite Filling. Materials, 3(2), 1228-1243.

  BACKGROUND

• Carvalho JC. Caries process on occlusal surfaces: evolving evidence and understanding. Caries Res. 2014;48(4):339-46. doi: 10.1159/000356307.

  PMID: 24577073 BACKGROUND

• Banerjee A. Minimal intervention dentistry: part 7. Minimally invasive operative caries management: rationale and techniques. Br Dent J. 2013 Feb;214(3):107-11. doi: 10.1038/sj.bdj.2013.106.

  PMID: 23392023 BACKGROUND

• Aref A, Abd-Elhakim S, Riad M. 24-month randomized controlled clinical trial assessment of surface texture, color stability, and marginal discoloration of sonic activated bulk-fill resin composite according to USPHS and FDI criteria. BMC Oral Health. 2025 Jul 26;25(1):1261. doi: 10.1186/s12903-025-06611-0.

  PMID: 40713556 BACKGROUND

• Al-Blaihed D, El-Housseiny AA, Farsi NJ, Farsi NM. Validity and reliability of the Arabic version of the child perceptions questionnaire for 8-10-year-old children. Qual Life Res. 2020 Nov;29(11):3131-3141. doi: 10.1007/s11136-020-02545-y. Epub 2020 Jun 10.

  PMID: 32524347 BACKGROUND

• Agrawal SK, Bhagat T, Shrestha A. Dental Caries in Permanent First Molar and Its Association with Carious Primary Second Molar among 6-11-Year-Old School Children in Sunsari, Nepal. Int J Dent. 2023 Mar 21;2023:9192167. doi: 10.1155/2023/9192167. eCollection 2023.

  PMID: 36998329 BACKGROUND

• Adsul PS, Dhawan P, Tuli A, Khanduri N, Singh A. Evaluation and Comparison of Physical Properties of Cention N with Other Restorative Materials in Artificial Saliva: An In Vitro Study. Int J Clin Pediatr Dent. 2022 May-Jun;15(3):350-355. doi: 10.5005/jp-journals-10005-2383.

  PMID: 35991795 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rehab Gamal Madani, bachelor of dentistry

  Faculty of Dentistry, Assiute University

  PRINCIPAL INVESTIGATOR

• Ahmed Abdelhamid Elheeny, PhD

  Faculty of Dentistry, Minia University

  STUDY CHAIR

• Moustafa Mohamed Sayed, PhD

  Faculty of Dentistry, Assiute University

  STUDY DIRECTOR

Central Study Contacts

Rehab Gamal Madani, master

CONTACT

+201010498491; rehab.gamal89pg@dent.s-mu.edu.eg

Ahmed Abdelhamid Elheeny, PhD

CONTACT

00201064257135; ahmedelheeny@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of pediatric dentistry

Model Details: Sample size was calculated for a paired split-mouth design using McNemar's test for correlated binary dichotomized outcomes. Considering an 80% clinical success rate for resin composite restorations (Bioactive injectable composite) over one year of follow-up, and a 94% clinical success rate for the Cention N -data obtained from a pilot study of 12 patients-and assuming a within-subject correlation (ρ) of 0.25, a two-sided alpha level of significance of 5%, and a statistical power of 80%, a total of 100 patients were required after adding 15% to compensate for potential drop-out.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 14, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): September 9, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)