Comparative Evaluation of Clinical Success, Plaque retention, Gingival health Patient satisfaction between Preformed stainless steel crowns and Bioflex crowns in children of 4-8 years

Comparative Evaluation of Clinical Success with Preformed Stainless Steel Crowns and Bioflex Crowns 9 Month Follow up Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077894

Enrollment

Registered

2024-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: BIOFLEX CROWNS: Evaluating the clinical success of Bioflex crowns and comparing it with the control group-9 month follow up Control Intervention1: STAINLESS STEEL CROWNS: Evaluating the

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children in the age group between 4 to 8 years indicated for pulpectomy 2. Cooperative children 3. Lower second primary molars after pulpectomy procedure. 4. Lower second primary molars having two thirds of root structure left radiographically.

Exclusion criteria

Exclusion criteria: 1. Uncooperative children (Frankl behavior: definitely negative) 2. Tooth mobility 3. A pathological root resorption 4. Primary molars not having sufficient crown structure •Primary molars with root caries

Design outcomes

Primary

Measure	Time frame
1.Crown retention will be evaluated as intact/displaced, chipped/broken/fracture, complete loss of crown. 2.Stain resistance will be evaluated as no staining, minor staining and noticeable staining. 3. Opposing tooth will be evaluated as wear, no wear. 4. Marginal integrity will be determined through visible inspection and tactile examination with an explorer as closed margin and open margin. 5. Proximal contact area between the first and second molar will be recorded as intact or lost by passing a dental floss. 6. Clinician satisfaction criteria will be evaluated as surface gloss, roughness, aesthetic and anatomical form using five-point Likert’s scale. 7. Children’s acceptance to the treatment will be evaluated by the Smiley scale Timepoint: 3, 6 and 9 months follow up	—

Measure

Time frame

1.Crown retention will be evaluated as intact/displaced, chipped/broken/fracture, complete loss of crown. 2.Stain resistance will be evaluated as no staining, minor staining and noticeable staining. 3. Opposing tooth will be evaluated as wear, no wear. 4. Marginal integrity will be determined through visible inspection and tactile examination with an explorer as closed margin and open margin. 5. Proximal contact area between the first and second molar will be recorded as intact or lost by passing a dental floss. 6. Clinician satisfaction criteria will be evaluated as surface gloss, roughness, aesthetic and anatomical form using five-point Likert’s scale. 7. Children’s acceptance to the treatment will be evaluated by the Smiley scale Timepoint: 3, 6 and 9 months follow up

—

Secondary

Measure	Time frame
Gingival status Periodontal statusTimepoint: 3, 6, 9 months follow up	—

Countries

India

Contacts

Public ContactNikhitha Elsa Shaji

SRI SIDDHARTHA DENTAL COLLEGE, TUMKUR

jyothsnasrikanth@gmail.com9495639631

Outcome results

None listed

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