Comparison of single visit Novel design space maintainer with conventional two visit space maintainer

Comparative clinical evaluation of Novel chairside customizable preformed band and loop space maintainer Vs Conventional band and loop space maintainer: A 6 month follow up study in 4-9 year old children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041600

Enrollment

Registered

2022-04-04

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Health Condition 1: K084- Partial loss of teeth

Interventions

Intervention1: Novel chairside customizable preformed band and loop space maintainer: This novel appliance can be placed in a single appointment. The Novel band and loop space maintainer has a male an

Eligibility

Inclusion criteria

Inclusion criteria: Clinical criteria- Age group 4 to 9 years: 1.Patients with premature loss of primary first or second molar in any of the arches. 2.Presence of Angleâ??s Class I molar relationship and or presence of flush terminal/mesial step primary molar occlusion. 3.Absence of abnormal dental habits and conditions such as thumb sucking, tongue thrusting, open bite, and cross bite. 4.No missing tooth in the opposite arch. Radiographic criteria: 1.Absence of any periapical pathology with abutment tooth. 2.Presence of succedaneous tooth bud. 3.Presence of more than 1 mm bone overlying the succedaneous tooth bud and/ or less than one third of the root of permanent tooth formed.

Exclusion criteria

Exclusion criteria: 1.Abutment tooth requiring endodontic treatment. 2.Patient with a history of systemic disease. 3.Missing teeth on mesial and distal side of edentulous area.

Design outcomes

Primary

Measure	Time frame
1.To evaluate the clinical efficacy in terms of nature of complications leading to failure of Novel chairside customizable preformed band and loop space maintainer placed following primary tooth loss in 4-9 year old children. 2.To evaluate the clinical efficacy in terms of nature of complications leading to failure of Conventional band and loop space maintainer placed following primary tooth loss in 4-9 year old children.Timepoint: 1 month, 3 months, 6 months follow up	—

Measure

Time frame

1.To evaluate the clinical efficacy in terms of nature of complications leading to failure of Novel chairside customizable preformed band and loop space maintainer placed following primary tooth loss in 4-9 year old children. 2.To evaluate the clinical efficacy in terms of nature of complications leading to failure of Conventional band and loop space maintainer placed following primary tooth loss in 4-9 year old children.Timepoint: 1 month, 3 months, 6 months follow up

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Secondary

Measure	Time frame
To compare the gingival health, patient satisfaction and overall success rate of Novel chairside customizable preformed band and loop space maintainer and Conventional band and loop space maintainer placed following primary tooth loss in 4-9 year old children.Timepoint: 1 month, 3 months, 6 months	—

Countries

India

Contacts

Public ContactDr Rupal chaudhari

Sinhgad Dental College and Hospital,Pune

ampanse82@gmail.com9689930396

Outcome results

None listed

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