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

NCT06573463 | Not Yet Recruiting

• 1 other identifier: Conventional vs prefabricated
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Premature Tooth Exfoliation

Outcome Measures

Primary Outcomes (2)

• Gingival Health

  By using gingival index of Loe and Silness ,scores gingival inflammation from 0-3 0 = normal gingiva 1. = mild inflammation: slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation: redness, edema, glazing, or bleeding on probing 3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding

  3 month and 9 month

• Cement integrity

  Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No)

  3 month and 9 month

Secondary Outcomes (2)

• Space loss between the abutment teeth.

  0 month and 9 month

• Change in arch dimension:

  0 month and 9 month

Study Arms (2)

Conventional band and loop

ACTIVE COMPARATOR

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

Prefabricated band and loop

ACTIVE COMPARATOR

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

Interventions

Prefabricated band and loop DEVICE

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.

Also known as: Ready-made band and loop, Chairside band and loop

Prefabricated band and loop

Conventional Band and loop DEVICE

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.

Conventional band and loop

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• /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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (5)

• 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.

  PMID: 35082473 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 16823234 BACKGROUND

• 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.

  PMID: 38890410 BACKGROUND

• 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.

  PMID: 37380944 BACKGROUND

Study Officials

• Dina Y El Kharadly, Lecturer

  October 6 University

  STUDY DIRECTOR

Central Study Contacts

Lamis A Badawi

CONTACT

02001221184776; lamis.abdelkhale@dentistry.cu.edu.eg

Sherif B Eltaweil, Professor

CONTACT

02001001481711; Sherif.eltaweil@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will not be feasible neither for the operator nor the patient. As there are some differences in the clinical steps, the form of the appliances and number of needed visits. Outcome assessor and Statistician will be blinded from the intervention and control not knowing which group represents which procedure.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A randomized controlled clinical trial, parallel group, allocation ratio 1:1 Framework superiority

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 27, 2024
• Study Start: December 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

EG (1)