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

NCT06558812 | Not Yet Recruiting

• 1 other identifier: Prefabricated space maintainer
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature Tooth Exfoliation

Outcome Measures

Primary Outcomes (1)

• appliance success

  evaluation of clinical success criteria ( • Integrity of each component of band and loop - solder breakdown - decementation - abutment fracture - Soft tissue impingement ) Clinical examination by operator ( binary yes or no )

  0-3-9 month

Secondary Outcomes (4)

• Space loss between the abutment teeth.

  0-9 month

• arch dimension

  0-9 month

• • Patient satisfaction

  during insertion of appliance

• • Cost effectiveness

  through study completion , an average of 9 month

Study Arms (2)

conventional space maintainer

OTHER

Conventional band and loops have been widely used with a high rate of success as the most practical way of space maintenance, as reported in numerous articles . Band and loop space maintainer is used to maintain space for successors of early lost primary molars. This is due to the ease and practicality of fabrication, adjustments and repairs of this space maintainer, as well as its ability to continue to function until the eruption of the permanent successor without interfering with their eruption 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.

Device: conventional space maintainer

prefabricated space maintainer

OTHER

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

Device: prefabricated space maintainer

Interventions

prefabricated space maintainer DEVICE

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 cemented with glass ionomer,

Also known as: chair side space maintainer

prefabricated space maintainer

conventional space maintainer DEVICE

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 .

conventional space maintainer

Eligibility Criteria

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

You may qualify if:

• 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
• /3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.

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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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

• 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 BACKGROUND

Related Links

• Related Info
• Related Info

Study Officials

• Dina Yousry El Kharadly, Lecturer

  October 6 University

  STUDY DIRECTOR

Central Study Contacts

amal fathi mahmoud sakr sakr

CONTACT

02001060718817; amal.fathy@dentistry.cu.edu.eg

Dr.Sherif Bahgat El Tawil El Tawil, 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: TREATMENT
• 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 12, 2024
• First Posted: August 19, 2024
• Study Start: December 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08