Comparative evaluation of the clinical success and periodontal effect of Conventional band and loop, Prefabricated E- space maintainers and Fiber reinforced composite resin space maintainers: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- DrIccha Upadhyay
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Clinical success and periodontal health of band and loop space maintainers
Overview
Brief Summary
This study is a randomized controlled clinical trial comparing the clinical success and periodontal effects of three types of space maintainers in children aged 4–8 years:
- Conventional band and loop space maintainers
- Prefabricated E-band and loop space maintainers
- Fiber-reinforced composite resin (FRCR) space maintainers
A total of 45 children meeting strict inclusion criteria will be randomly assigned to one of the three groups (15 per group). Each child will receive the allocated appliance after extraction of a primary molar. The plaque index (PI) and gingival index (GI) will be recorded for the banded tooth at 1, 3, and 6 months to evaluate periodontal health, and appliance failures (cement loss, deformation, debonding, etc.) will be documented to assess clinical success.
The study aims to determine whether prefabricated E-band and loop or FRCR space maintainers perform better than conventional designs in terms of survival rate, periodontal health, and patient comfort, based on existing literature suggesting potential advantages like reduced chair time, better aesthetics, and less risk to abutment teeth. Data will be analyzed using Chi-square, repeated measures ANOVA, and independent t-tests.
In essence, the trial seeks evidence to guide pediatric dentists toward the most effective, patient-friendly, and periodontally safe space maintainer option for managing premature primary molar loss.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children between the age group of 4-8 years with Frankels behaviour rating score of 1 and 2 2.Systemically healthy children.
- •3.Children with missing maxillary or mandibular primary molars 4.Sound and healthy teeth adjacent to the missing tooth.
- •5.No abnormal dental conditions such as crossbite, open bite, and deep bite.
- •6.Presence of succedaneous tooth bud.
- •7.Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one-third of the root formed.
Exclusion Criteria
- •Children with special health care needs.
- •Children with underlying any systemic conditions.
- •Children who are allergic to local anaesthesia or any of the materials used in the study.
- •Grossly carious teeth adjacent to the missing tooth.
Outcomes
Primary Outcomes
Clinical success and periodontal health of band and loop space maintainers
Time Frame: 1,3 and 6 month
Secondary Outcomes
- To assess and compare the clinical success of Conventional band and loop space maintainers, Prefabricated E- space maintainers and Fiber reinforced band–loop space maintainers at 1,3 and 6 months
Investigators
Iccha Upadhyay
SRM Ramapuram