Clinical trial NCT06558812: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Tooth Exfoliation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial, parallel group, allocation ratio 1:1 Framework superiority
Primary purpose: TREATMENT

Brief summary: 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

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.

Primary outcomes:
measure: appliance success
timeFrame: 0-3-9 month
Secondary outcomes:
measure: Space loss between the abutment teeth.
timeFrame: 0-9 month
measure: arch dimension
timeFrame: 0-9 month
measure: • Patient satisfaction
timeFrame: during insertion of appliance
measure: • Cost effectiveness
timeFrame: through study completion , an average of 9 month
Other outcomes:
Locations:
Study officials:
affiliation: October 6 University
name: Dina Yousry El Kharadly, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.