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

Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars

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

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Tooth Exfoliation
• Intervention / Treatment: Device: Conventional Band and loop; Device: Prefabricated band and loop

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lamis A Badawi; Phone Number: 02001221184776; Email: lamis.abdelkhale@dentistry.cu.edu.eg
• Study Contact Backup: Name: Sherif B Eltaweil, Professor; Phone Number: 02001001481711; Email: Sherif.eltaweil@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University
    • Contact: Lamis A Badawi; Phone Number: 01221184776; Email: lamis.abdelkale@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional band and loop; 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.	Device: Conventional Band and loop; Conventional band and loop is the most widely used space maintainer, It shows high success rate and good patient compliance, but needs more than one visit due to the laboratory work.
Active Comparator: Prefabricated band and loop; 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.	Device: Prefabricated band and loop; 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.; Other Names: Ready-made band and loop; Chairside band and loop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cement integrity	Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No)	3 month and 9 month
Gingival Health	By using gingival index of Loe and Silness ,scores gingival inflammation from 0-3 0 = normal gingiva; = mild inflammation: slight change in color, slight edema, no bleeding on probing; = moderate inflammation: redness, edema, glazing, or bleeding on probing; = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding	3 month and 9 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Space loss between the abutment teeth.	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.	0 month and 9 month
Change in arch dimension:	Arch perimeter: Measured on digital cast as a sum of the incisor, canine and molar segment widths in mm.; Inter canine width : Measured on 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.	0 month and 9 month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Dina Y El Kharadly, Lecturer, October 6 University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Conventional vs prefabricated

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No