Clinical comparison of Bioflx and Zirconia crown restorations for primary molars.

Comparison of clinical efficiency and the adherence of streptococcus mutans to primary molars restored with Bioflx and zirconia crowns. – A Split mouth Observational Study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062400

Enrollment

Registered

2024-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Bioflx crowns: post Pulpectomy the tooth will be prepared for group A- Bioflx crowns the preparation will be done as per manufacturers instructions and then will be assessed for clinic

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged between 4 to 8 years . 2.Presence of at least one carious primary molar indicated for pulpectomy on either side of the maxillary or mandibular arch (split mouth). 3.. Primary molars with irreversible pulpitis or non-vital pulp which show a restorable tooth structure (adequate sound coronal tooth structure) and have an adequate periodontal support which is confirmed by periapical radiographic examinations 4. Children who fall under Frankle’s behavior Rating 3,4 5.Children whose parents gave consent to participate in the study. 6.Children with no history of antibiotic intake or fluoride application in the last 14 days.

Exclusion criteria

Exclusion criteria: 1)Children with Special health care needs. 2) Children with any underlying systemic conditions. 3) Children who are uncooperative. 4) Children who are allergic to Local anesthesia or any of the materials used in the study. 5) Teeth which show extensive mobility due to a pre-shedding state or a pathology. 6)The presence of bone rare fraction involving more than a half of the root, severe mobility or resorption of more than half of the root or root perforations. 7) Tooth with underfilled or overfilled obturation

Design outcomes

Primary

Measure	Time frame
The expected primary outcome of the study is that Bioflx™ crowns show comparable clinical efficiency and a low streptococcus mutans adhesion when compared to zirconia crownsTimepoint: Follow up will be done at 1, 3 and 6 months	—

Secondary

Measure	Time frame
The expected secondary outcome of the study is a comparable periodontal health of primary molars restored with Bioflx™ and Zirconia crowns.Timepoint: 1 month , 3 months and 6 months follow up	—

Countries

India

Contacts

Public ContactDrPShankar

SRM Dental College, Ramapuram , Chennai

ag4000@srmist.edu.in9884585808

Outcome results

None listed

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