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A comparison of banded space maintainer versus bonded space maintainer -a randomized control trial

Comparison of Clinical Success,Salivary Parameters and Patient Acceptance of Banded versus Bonded Space maintainer in 6-9 Year old children-A Randomized Control Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039141
Enrollment
30
Registered
2022-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: FRCR space maintainer: Bonded space maintainer is the intervention used.FRCR(Ribbond) space maintainer is bonded on abutment teeth in relation to the extraction site 74 or 84.The total

Sponsors

Dr Umm Kulthum Moideen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA 1. Clinical criteria 1) 6-9 years old healthy children without any systemic disease 2)Extraction site in relation to 74 or 84 preferably 1 week after the extraction 3) Sound and healthy adjacent teeth where ribbond or band and loop are fixed (abutment teeth) 4) Absence of crossbite, open bite and deep bite 5) Parents and patients who are willing to participate in the study. 2. Radiographic criteria 1) Absence of periapical pathology in relation to abutment teeth. 2) Presence of succedaneous tooth bud. 3) Presence of more than one mm bone overlying the succedaneous tooth germ and/or less than one third of root of permanent tooth formed

Exclusion criteria

Exclusion criteria: 1) Parents and children who are not willing to participate in the study 2) Carious on buccal and lingual surfaces of abutment teeth. 3) Absence of teeth on mesial and distal side of edentulous area. 4) Patients with systemic diseases or children with any differentially challenged conditions

Design outcomes

Primary

MeasureTime frame
Clinical success which includes failure criterias of FRCR and band and loop space maintainers ,caries status and gingival health status .Timepoint: At baseline 3months and 6months

Secondary

MeasureTime frame
Salivary parameter changes which includes salivary IgA,salivary pH and buffering capacity. Patient acceptance .Timepoint: At baseline 3 months and 6 months

Countries

India

Contacts

Public ContactDr Umm Kulthum Moideen

Government Dental college Kottayam

jeevareghu@gmail.com9447300050

Outcome results

None listed

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