Clinical trial NCT06573463: Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers
Official title: Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Tooth Exfoliation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-27
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: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival Health
timeFrame: 3 month and 9 month
measure: Cement integrity
timeFrame: 3 month and 9 month
Secondary outcomes:
measure: Space loss between the abutment teeth.
timeFrame: 0 month and 9 month
measure: Change in arch dimension:
timeFrame: 0 month and 9 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: October 6 University
name: Dina Y El Kharadly, Lecturer
role: STUDY_DIRECTOR
References:
citation: Kamki H, Kalaskar R, Balasubramanian S, Badhe H, Kalaskar A. Clinical Effectiveness of Fiber-reinforced Composite Space Maintainer and Band and Loop Space Maintainer in a Pediatric Patient: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S82-S93. doi: 10.5005/jp-journals-10005-2044.
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: Padma Kumari B, Retnakumari N. Loss of space and changes in the dental arch after premature loss of the lower primary molar: a longitudinal study. J Indian Soc Pedod Prev Dent. 2006 Jun;24(2):90-6. doi: 10.4103/0970-4388.26023.
citation: Thakur B, Bhardwaj A, Luke AM, Wahjuningrum DA. Effectiveness of traditional band and loop space maintainer vs 3D-printed space maintainer following the loss of primary teeth: a randomized clinical trial. Sci Rep. 2024 Jun 18;14(1):14081. doi: 10.1038/s41598-024-61743-7.
citation: Zhao J, Jin H, Li X, Qin X. Dental arch spatial changes after premature loss of first primary molars: a systematic review and meta-analysis of split-mouth studies. BMC Oral Health. 2023 Jun 28;23(1):430. doi: 10.1186/s12903-023-03111-x.