comparing gum health and effectiveness of two types of dental space maintainer in children

Comparison of Gingival Inflammatory Markers and Clinical Outcomes of Conventional and Prefabricated Band and Loop Space Maintainers: A Split-Mouth Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087667

Enrollment

Registered

2025-05-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

None listed

Interventions

Intervention1: PREFABRICATED BAND AND LOOP SPACE MAINTAINER: a.Mesiodistal width of the abutment tooth will be measured using a caliper. b.A preformed band with a tube (e-space maintainer, Kids-e-dent

Eligibility

Inclusion criteria

Inclusion criteria: Clinical Criteria 1 Age group: 4 9years. 2 Bilateral loss of mandibular first deciduous molars due to caries. 3 No evidence of space loss at the extraction site, with extractions performed within the past 6 months. Radiographic Criteria: 1 Presence of permanent tooth buds beneath the extraction site. 2 Adequate bone coverage over the extraction site. 3 Absence of root furcation involvement, tooth mobility, or abscess formation in abutment teeth.

Exclusion criteria

Exclusion criteria: 1.Presence of multi-surface dental decay or pulp involvement in abutment teeth. 2.Loss of teeth anteriorly or posteriorly adjacent to the edentulous space. 3.Abnormal dental conditions or habits such as thumb sucking, tongue thrusting, open bite, or crossbite. 4.Presence of tooth mobility, abscess, or any systemic diseases impacting oral health.

Design outcomes

Primary

Measure	Time frame
1.Chemokine Levels in GCF: Levels of MIP-1alpha and MIP-1beta in gingival crevicular fluid (GCF) collected from children with conventional and prefabricated band and loop space maintainers, analyzed using ELISA. Timepoint: baselines and 6 months	—

Secondary

Measure	Time frame
1.Clinical Periodontal Parameters: Gingival Index (GI) Plaque Index (PI) 2.Survival Rate 3.Patient s Acceptance and Satisfaction Timepoint: Before intervention, T1 (one month post-intervention), T2 (three months post-intervention), T3 (six months post-intervention)	—

Countries

India

Contacts

Public ContactDr Rajeev kumar singh

Faculty of dental sciences,Kgmu,Lucknow

rajeevkumarsingh@kgmcindia.edu9450849528

Outcome results