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A Study on How Two Types of Dental Devices Affect Gum Healing and Cleanliness in Children Who Have Lost Baby Teeth

Comparative Evaluation of the Effect of Pre-Fabricated and Conventional Band and Loop Space Maintainer on Post-Extraction Wound Healing and Assessment of Plaque Accumulation and Gingival Health of the Abutment Tooth: A Split Mouth Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091332
Enrollment
30
Registered
2025-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: K081- Complete loss of teeth

Interventions

Intervention1: Pre-fabricated band and loop space maintainer: Prefabricated space maintainers are commonly used in pediatric dentistry to prevent space loss after premature primary tooth loss. They ar

Sponsors

Kalyani Barve
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Bilateral primary mandibular first molars indicated for extraction, Presence of a succedaneous tooth bud confirmed radiographically, Healthy abutment tooth, Adequate bone coverage that indicates more than 6 months remained until permanent tooth eruption

Exclusion criteria

Exclusion criteria: Succedaneous tooth with more than 1/3rd of root already calcified, Space left by prematurely lost teeth is greater than space needed for the permanent successor, Succedaneous tooth is absent, Medically compromised children and children with special health care needs.

Design outcomes

Primary

MeasureTime frame
Wound HealingTimepoint: Day 3 and Day 7

Secondary

MeasureTime frame
Plaque accumulation & Gingival health statusTimepoint: Baseline, 1 month, 2 months, 3 months

Countries

India

Contacts

Public ContactKalyani Barve

Department of Pediatric and Preventive Dentistry, Government Dental College and Hospital, Mumbai

dimplepadawe@gmail.com

Outcome results

None listed

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