MedPath

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

Phase 4
Conditions
Health Condition 1: K040- Pulpitis
Registration Number
CTRI/2024/02/062400
Lead Sponsor
DrApoorva Goswami
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The expected primary outcome of the study is that Bioflx™ crowns show comparable clinical <br/ ><br>efficiency and a low streptococcus mutans adhesion when compared to zirconia crownsTimepoint: Follow up will be done at 1, 3 and 6 months
Secondary Outcome Measures
NameTimeMethod
The expected secondary outcome of the study is a comparable periodontal health of primary <br/ ><br>molars restored with Bioflx™ and Zirconia crowns.Timepoint: 1 month , 3 months and 6 months follow up
© Copyright 2025. All Rights Reserved by MedPath