This is a study comparing the efficiency of two different oral appliance that is used to preserve the space for the erupting permanent teeth

Comparative evaluation of clinical success of conventional space maintainer versus prefabricated space maintainer in children aged 4 to 9 years - A split-mouth randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062845

Enrollment

Registered

2024-02-19

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

None listed

Interventions

Intervention1: Space maintainer: Prefabricated space maintainer for 9 months Control Intervention1: Space maintainer: Conventional space maintainer for 9 months

Eligibility

Inclusion criteria

Inclusion criteria: Clinical criteria: Systemically healthy children. Grossly mutilated or resorbed primary molars bilaterally requiring extraction before the complete eruption of permanent mandibular anteriors. Sound and healthy teeth adjacent to the extraction site. No abnormal dental conditions such as crossbite, open bite, and deep bite. Radiographic criteria: Presence of succedaneous tooth bud. Presence of at least 1 mm bone overlying the succedaneous Tooth germ with less than one-third of the root formed.

Exclusion criteria

Exclusion criteria: Parents who didn’t give consent Individuals having systemic diseases or severe medically compromised. Grossly carious teeth were adjacent to the created space. Absence of teeth on the mesial or distal side of the teeth to be extracted

Design outcomes

Primary

Measure	Time frame
Survival rateTimepoint: Baseline, 1 month, 3 months, 6 months and 9 months	—

Secondary

Measure	Time frame
Gingival health, Incidence of caries in abutment tooth, Space lossTimepoint: Baseline, 1 month, 3 months, 6 months and 9 months	—

Countries

India

Contacts

Public ContactAyesha Fathima

Saveetha Dental College

maheshpedo@gmail.com9840322728

Outcome results