Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers

Cairo University (CU)

Status: Not yet enrolling

Conditions: Premature Tooth Exfoliation

Treatments: Device: Prefabricated band and loop; Device: Conventional Band and loop

Study type: Interventional

Funder types: Other

Identifiers

NCT06573463

Conventional vs prefabricated

Details and patient eligibility

About

To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars.

A Randomized Clinical Trial

Full description

When considering gingival health and cement dissolution, does the longevity of the prefabricated band and loop differ from the conventional band and loop constructed following the premature loss of the lower first primary molars?

The concept of preserving space after premature tooth loss has been recognized for over a century. Conventional appliances are used successfully as space maintainers, but some disadvantages like the need for at least two visits to deliver the appliance due to laboratory work, will definitely affect its role during the general anesthesia.

The prefabricated space maintainer requires only one visit as it is fitted into the patient's mouth at the clinic without needing the dental lab. This provides a good impact on apprehensive children as it reduces the number of visits and chairside time. Prefabricated space maintainers could be a new alternative to the conventional fixed space maintainers used in pediatric dentistry.

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
• Caries free, or restored mandibular second primary molars and deciduous canines on the side of the extraction maintained throughout the entire follow-up period.
• Children are classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
• According to space analysis, available space is less than or equal to the needed space
• 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars
• Children are mentally capable of communication.
• Children aged 4-6 years

Exclusion criteria

• Children with any parafunctional habits.
• Children with previous allergies to stainless steel.
• Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
• Parental refusal of participation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Conventional band and loop

Active Comparator group

Description:

Conventional band and loop is the most widely used space maintainer, and the most effective. It shows high success rate and good patient compliance, but it needs more than one visit to be applied.

Treatment:

Device: Conventional Band and loop

Prefabricated band and loop

Active Comparator group

Description:

Prefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes.

Treatment:

Device: Prefabricated band and loop