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Bioactive composite in restoring class II cavities in primary teeth

Evaluation of the effectiveness of bulk-fill bioactive composite in restoring class II cavities in primary teeth and comparing it with traditional composite and resin-modified glass ionomer (randomized-split mouth-clinical trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98762227
Enrollment
80
Registered
2024-06-17
Start date
2023-12-30
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Restoring of Class II dental caries with bioactive composite, traditional composite and resien modified glass inomer Oral Health

Interventions

This is an experimental prospective double-blinded (the patient and the examiner) split-mouth randomized controlled trial. The study patients will be divided into two groups using the randomization we

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. An informed consent will be signed by the parents after their approval to participate in the study 2. All the patients should be healthy (ASA1) and cooperative 3. All the selected teeth will be on either side of the jaw, upper or lower jaw, and both primary molars (first and/or second) with occlusal and proximal enamel/dentine caries with a 4/5 score according to ICDAS 4. All teeth should be vital, restorable and free of these symptoms: spontaneous pain, swelling, fistula, abscess or tenderness on percussion, and pathological mobility

Exclusion criteria

Exclusion criteria: 1. Unhealthy patient 2. Uncooperative patient 3. If one or more of the abovementioned inclusion criteria is not obtained

Design outcomes

Primary

MeasureTime frame
Anatomical form, Marginal integrity, Marginal discoloration, Color stability, Recurrent caries, Surface texture of all the restored teeth measured by two blinded and calibrated evaluators using modified United States Public Health Service (USPHS) Ryge Criteria at 3, 6 and 9 months

Secondary

MeasureTime frame
The following secondary outcome variables will be measured by two blinded and calibrated evaluators using modified United States Public Health Service (USPHS) Ryge Criteria at 3, 6 and 9 months: 1. Clinical success and caries degree 2. Clinical success and within the restoration in the upper or lower jaw 3. Clinical success and within the restoration mesial or distal 4. Clinical success and within the restoration in the first or second molar

Countries

Syria

Contacts

Public ContactSafaa Bassam Shihabi
safaa2671991@gmail.com+963 0934101164

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026