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Comparison of two appliances used to preserve space in children with early loss of milk teeth

Comparative evaluation of Prefabricated Band and Loop Space Maintainer and Conventional Band and Loop Space Maintainer over a period of time: an In Vivo study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111743
Enrollment
54
Registered
2026-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Prefabricated band and loop space maintainer: Placement of an appropriately selected and adapted prefabricated band and loop space maintainer on the abutment tooth following premature l

Sponsors

Punjab Government Dental College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with decayed primary first molar or primary second molar or grossly carious non restorable pulpally/furcally involved primary molar teeth indicated for extraction in maxillary or mandibular arch in any quadrants. Existence of the flush terminal/mesial step primary molar relationship and/or Angle s class I molar relationship. Absence of any periapical pathology with respect to the abutment tooth. Presence of succedaneous tooth bud. Presence of more than 1mm of bone overlying or less than one-third of root formation of the succedaneous tooth germ. Healthy children with no significant medical history or systemic diseases.

Exclusion criteria

Exclusion criteria: Abutment teeth with poor prognosis (mobility and resorption of the root). Excessive spacing and crowding. Patients indicated for space regaining procedures due to space loss. Poor oral hygiene maintenance. Patients with special care needs/differently abled. Medically compromised patients. Permanent incisors completely erupted. Caries involving pulp on abutment tooth and periodontally compromised abutment. Patient with abnormal dental conditions such as crossbite, open bite and deep bite. Parents/Guardians not willing to sign the consent form. Patients with Class II and III molar relationships. Any abnormal oral habits.

Design outcomes

Primary

MeasureTime frame
1. Satisfactory clinical performance of Prefabricated band and loop space maintainer 2. Satisfactory clinical performance of Conventional band and loop space maintainer Timepoint: baseline (TO), 1 month (T1), 3 months (T2) and 6 months (T3)

Secondary

MeasureTime frame
Prefabricated band and loop space maintainer show comparable clinical performance as Conventional band and loop space maintainer after premature loss of primary molarsTimepoint: baseline (TO), 1 month (T1), 3 months (T2) and 6 months (T3)

Countries

India

Contacts

Public ContactDr Nitika Bajaj

Punjab Government Dental College and Hospital Amritsar

drnitika_bajaj81@yahoo.co.in9876194481

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026