Comparing the performance of two types of aesthetic crowns for children's primary teeth

Evaluation of the clinical performance of two types of prefabricated aesthetic crowns in the restoration of primary molars: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52747143

Enrollment

100

Registered

2025-05-27

Start date

2025-05-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Extensively decayed second primary molars requiring pulpotomy and full coronal restoration Oral Health

Interventions

Participants were randomly assigned to one of four study groups using computer-generated block randomisation (block size = 8). An independent researcher generated the sequence and prepared sealed, opa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 6–10 years 2. Good/acceptable oral hygiene 3. Positive or definitely positive Frankl behavior rating 4. Indication for full-coverage restoration (endodontically treated teeth) 5. Absence of mobility or sinus tract 6. Healthy child (no systemic illness or medication-induced gingival overgrowth) 7. Normal occlusion, no bruxism 8. Presence of opposing and adjacent teeth 9. Signed informed consent and commitment to follow-ups

Exclusion criteria

Exclusion criteria: 1. Poor oral hygiene or presence of uncontrolled plaque or gingivitis 2. Uncooperative behavior, defined as negative or definitely negative on the Frankl behavior rating scale 3. Children with systemic illnesses or conditions that may affect gingival health (e.g., medication-induced gingival overgrowth)

Design outcomes

Primary

Measure	Time frame
The following primary clinical and photographic evaluations are carried out at 1, 6, and 12 months: 1. Oral Hygiene Index-Simplified (OHIS), defined as 0 = No debris; 3 = Debris > 2/3 of surface. Interpretation: 0–1 = Good, 1–2 = Fair, 2–3 = Poor 2. Plaque Index (PI), defined as 0 = absence of plaque, 1= Thin film of plaque, 2= moderate accumulation of plaque 3 = Large amount of Plaque 3. Gingival Index (GI), defined as 0 = Normal, 1= mild inflammation, 2= moderate inflammation 3 = Severe inflammation 4. Bleeding on Probing (BOP), defined as (-) = No bleeding, (+) = Bleeding after probing 5. Marginal integrity, defined as 0 = No gap, 2 = Visible gap	—

Measure

Time frame

The following primary clinical and photographic evaluations are carried out at 1, 6, and 12 months: 1. Oral Hygiene Index-Simplified (OHIS), defined as 0 = No debris; 3 = Debris > 2/3 of surface. Interpretation: 0–1 = Good, 1–2 = Fair, 2–3 = Poor 2. Plaque Index (PI), defined as 0 = absence of plaque, 1= Thin film of plaque, 2= moderate accumulation of plaque 3 = Large amount of Plaque 3. Gingival Index (GI), defined as 0 = Normal, 1= mild inflammation, 2= moderate inflammation 3 = Severe inflammation 4. Bleeding on Probing (BOP), defined as (-) = No bleeding, (+) = Bleeding after probing 5. Marginal integrity, defined as 0 = No gap, 2 = Visible gap

—

Secondary

Measure	Time frame
Contact points (0 = Normal, 2 = Open), Crown fracture (0 = Intact, 1 = Minor chipping, 2 = Cracks, 3 = Full fracture), measured using clinical and photographic evaluations to the United States Public Health Service (USPHS) Criteria at 1, 6, and 12 months	—

Countries

Syria

Contacts

Public ContactAhmad Taleb

ahmed.taleb1195@gmail.com+963 938466353

Outcome results

None listed

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