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NCT Number: NCT06558812

Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars

To assess the clinical efficacy of prefabricated space maintainers compared to conventional ones, focusing on preserving the integrity of each component of bands and loops, avoidance of soft tissue impingement as well as preservation of arch dimensions.

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Key information

Conditions

Premature Tooth Exfoliation

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Management of the developing occlusion lies firmly within the scope of pediatric dentistry, therefore protection of dental arch integrity and inter-arch relations in the premature loss of teeth can be guaranteed by placing space maintainers. Conventional appliances are used successfully as space maintainers, although they have some disadvantages.The need for at least two visits to delivery, therefore cannot be planned in patients under general anesthesia. Fabrication of conventional and loop requires an alginate impression and laboratory work.

Prefabricated band and loop devices have been introduced to dentistry in recent times. They can possibly overcome most of the previously mentioned limitations of conventional space maintainers. The prefabricated band and loop space maintainer is adjusted and applied in one visit and therefore can be planned in patients under general anesthesia. Other advantages include less time, more patient and parent satisfaction, and no laboratory work

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical criteria Medically free children.
  • Patient and parent showing cooperation and compliance.
  • Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
  • Freshly extracted single molars unilaterally or bilaterally
  • Unilateral or bilateral loss of primary molars before or after the eruption of the first permanent molar
  • Caries free or restored the mandibular second primary molars and deciduous canines in the side of the extraction maintained throughout the entire follow-up period.

Radiographic criteria

  • Presence of succedaneous tooth bud.
  • Presence of at least 1 mm bone overlying the succedaneous tooth germ
  • 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.

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.

Treatment and study plan

prefabricated space maintainer

Device

i. Prefabricated band will be selected for the abutment tooth by measuring the mesiodistal diameter of the abutment tooth with a caliper and will be adjusted with the internal diameter of the prefabricated band.

ii. The loop will be selected based on the available mesiodistal space and buccolingual width of the abutment tooth, excessive length with be cut by cutting plier and will then place inside the band's tube by using a HOWE pliers.

iii. Cotton roll isolation will use, then will be cemented with glass ionomer,

Other names: chair side space maintainer

conventional space maintainer

Device

i. A full arch Impressions will be taken with alginate material. ii. Impressions will be poured up using dental stone within 30 min of the impression taking.

iii. The children will be given an appointment for space maintainer insertion. iv. In the second visit , Cotton roll isolation will use, cementation will be performed with glass ionomer .

Primary outcomes

  1. appliance success

    Time frame: 0-3-9 month

    evaluation of clinical success criteria ( • Integrity of each component of band and loop - solder breakdown - decementation - abutment fracture - Soft tissue impingement ) Clinical examination by operator ( binary yes or no )

Secondary outcomes

  1. Space loss between the abutment teeth.

    Time frame: 0-9 month

    • Change in distance measured on digital cast between the mesial midpoint of the second deciduous molar and the distal midpoint of the primary canine in mm

  2. arch dimension

    Time frame: 0-9 month

    measured each of

    • Arch perimeter by measured on a digital cast as a sum of the incisor, canine and molar segment width in mm
    • Inter canine width = Measured on a digital cast from cusp tip of canine on one side to cusp tip of canine on the other side in mm
    • Intermolar width = Measured on a digital cast from central fossa of the second primary molar on one side to central fossa of the second primary molar on the other side in mm

  3. • Patient satisfaction

    Time frame: during insertion of appliance

    Patient-reported using 5-point Likert-type scale from 1-5 face scale

  4. • Cost effectiveness

    Time frame: through study completion , an average of 9 month

    Manually by incremental effectiveness cost ratio ,measuring unit is financial units per result

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.Sherif Bahgat El Tawil El Tawil, professor

CONTACT

[email protected]

02001001481711

amal fathi mahmoud sakr sakr

CONTACT

[email protected]

02001060718817

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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