First permanent molars restored with Cention N in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 12-month, split-mouth randomized trial comparing Cention N with resin composite for restoration of bilateral first permanent molars in children. It will measure clinical outcomes, radiographic status, and oral-health-related quality of life. Eligible participants are healthy children (ASA I-II) aged 8-10 with bilateral carious lesions and good behavior who can attend regular follow-ups. The study focuses on the performance of Cention N in preserving tooth structure, preventing secondary decay, and its impact on patient well-being. No results are reported until the study is completed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Clinical:

1. Children aged 8-10 years.
2. Children classified as ASA physical status I or II.
3. Children demonstrate positive or definitely positive behavior (scores 3 or 4 on the Frankl Behavior Rating Scale).
4. Children who are available for regular recall visits throughout the study period.
5. Presence of bilateral carious lesions in permanent first molars, with a clear description of lesion depth whenever possible.
6. Asymptomatic vital permanent first molars showing no clinical or radiographic signs of pathology.

Radiographic:

1. Normal lamina dura and periodontal ligament space.
2. No apical radiolucency.

Exclusion Criteria:

Clinical:

1. Children with behavioral difficulties or without signed parental consent.
2. Children are classified as ASA physical status class III or higher.
3. Teeth presenting clinical signs of pulpitis or necrosis (e.g., nocturnal pain, fistula, abscess, pulp exposure, or pathological mobility).

Radiographic:

1. Evidence of abnormal radiolucency involving the pulp chamber or root apex.
2. Detection of furcal bone radiolucency or abnormal root resorption.

Where it's running

• Faculty of Dentistry, Minya university
  Minya, Asyut Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Rehab Gamal Madani, bachelor of dentistry — Faculty of Dentistry, Assiute University
• Study coordinator: Rehab Gamal Madani, master
• Email: rehab.gamal89pg@dent.s-mu.edu.eg
• Phone: +201010498491

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.