1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [pavithraramdas1998@gmail.com].
   


6. For how long will this data be available start date provided 02-12-2027 and end date provided 02-03-2029?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

Introduction

Early loss of primary teeth due to trauma or caries can lead to dental complications such as crowding, rotation, and midline shifts, potentially resulting in malocclusion. Maintaining the space left by prematurely lost deciduous teeth is essential to prevent orthodontic issues. Conventional band and loop (B&L) space maintainers are widely used, but prefabricated B&L space maintainers offer advantages such as reduced treatment time and lower technical demands. However, both types have been associated with gingival inflammation and plaque accumulation.Macrophage Inflammatory Proteins (MIP-1alpha and MIP-1beta) are chemokines involved in periodontal inflammation. Their role in children with space maintainers is not well understood. This study aims to evaluate and compare MIP-1alpha and MIP-1beta levels in the gingival crevicular fluid (GCF) of children using conventional and prefabricated B&L space maintainers, assessing their impact on gingival and periodontal health.

Objective

The primary objective is to compare MIP-1alpha and MIP-1beta levels in GCF and their association with gingival inflammation in children using conventional and prefabricated B&L space maintainers. Secondary objectives include assessing the survival rates, structural integrity, and patient acceptance of both space maintainer

Methodology

This split-mouth randomized controlled study will be conducted at King George’s Medical University. Ethical clearance will be obtained before initiation

Children aged 3-7 years with bilateral loss of mandibular first deciduous molars will be enrolled and randomly assigned to receive either a conventional or prefabricated B&L space maintainer. GCF samples will be collected at baseline and six months, and MIP-1alpha and MIP-1beta levels will be analyzed using ELISA. Periodontal parameters such as the Gingival Index (GI) and Plaque Index (PI) will be recorded at 1, 3, and 6 months. Survival rates, patient acceptance, and satisfaction will be evaluated through questionnaires.

Statistical analysis will be performed using SPSS software, with a significance level set at p less than 0.05.

Expected Outcomes

This study is expected to reveal differences in inflammatory responses between conventional and prefabricated space maintainers. Prefabricated maintainers may result in lower gingival inflammation and higher patient satisfaction due to better adaptation and reduced plaque accumulation.

Conclusion

Understanding the immunological response to space maintainers is crucial for optimizing their design and clinical application. This study will contribute to improved periodontal health management strategies, enhancing the long-term success of space maintainers in children.