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

Official 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

Overview

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.

Detailed description

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

Interventions

• Device prefabricated space maintainer
  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 cement
• Device conventional space maintainer
  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 outcome measures

• appliance success [Time frame: 0-3-9 month]

Secondary outcome measures (4)

• Space loss between the abutment teeth. [Time frame: 0-9 month]
• arch dimension [Time frame: 0-9 month]
• • Patient satisfaction [Time frame: during insertion of appliance]
• • Cost effectiveness [Time frame: through study completion , an average of 9 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Tahririan D, Safaripour M, Eshghi A, Bonyadian AH. Comparison of the longevity of prefabricated and conventional band and loops in children's primary teeth. Dent Res J (Isfahan). 2019 Nov 12;16(6):428-434. eCollection 2019 Nov-Dec. PMID 31803390
• Tyagi M, Rana V, Srivastava N, Kaushik N, Moirangthem E, Gaur V. Comparison of the Conventional Band and Loop Space Maintainers with Modified Space Maintainers: A Split-mouth Randomized Clinical Trial. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S63-S68. doi: 10.5005/jp-journals-10005-2046. PMID 35082470

Identifiers

NCT: NCT06558812 · Prefabricated space maintainer

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗