"Evaluation of Clinical Performance and Success Rate of CAD/CAM Versus Conventional Band and Loop Space Maintainer"

NCT05134714 | Unknown

• 1 other identifier: PED 21-4D
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits and gingival health and, the success rate of the appliances in terms of: survival time, cement loss and appliance breakage. And to compare both appliances in terms of patient satisfaction. This study consists of two parts: in vivo part (split mouth RCT) and in vitro part: In vivo study: Its sample size was found to be (36) cases (i.e. 18 case per group). Sample size calculation was performed using G\*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out. In this in vivo study split mouth will be randomly divided into two groups: Group 1: Conventional metal band and loop space maintainer Group 2: CAD/CAM zircon band and loop space maintainer In vitro study: its sample size was found to be (24) samples (i.e. 8 samples per group). Sample size calculation was performed using G\*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out. Grouping: The zirconia specimen divided randomly into three groups according to type of cements: Group 1: Self-adhesive resin cement Group 2: Resin-modified glass ionomer cement Group 3: Universal bioactive cement

Conditions

CAD/CAM Space Maintainer

Keywords

space maintainer; CAD/CAM space maintainer

Outcome Measures

Primary Outcomes (3)

• Clinical success: Evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits (Plaque index)

  Plaque index, that is running in a scale from 0 to 3 where 0 means no plaque,1 film of plaque adhering to free gingival margin,2 moderate accumulation of soft deposits on the tooth and gingival margin, and 3 means abundance of soft debris.

  Up to 12 months

• Clinical success: Evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of Gingival health, by assessing the gingival index.

  Gingival health, scores from 0 to 3 where 0 no inflammation, 1slight redness no bleeding on probing, 2 redness and bleeding on probing, and 3 severe inflammation with edema and ulceration to spontaneous bleeding,47 and patient satisfaction.

  up to 12 months

• The success rate of appliances in terms of survival time.

  Clinical evaluation of success rates of the modalities regarding survival time by checking both space maintainers and identify if there is cement loss or breakage of the appliances during the follow up period.

  Up to 12 months

Secondary Outcomes (1)

• Compare both appliances in terms of patient satisfaction.

  Up to 12 months

Study Arms (2)

Group 1(study group): CAD/CAM zircon band and loop space maintainer

EXPERIMENTAL

Solid monolithic zirconia material which utilizes CAD/CAM technology for its designing and milling of the restoration will be used for fabrication of the space maintainer.

Device: CAD/CAM zircon band and loop space maintainer; Device: Conventional metal band and loop space maintainer

Group 2(control): Conventional metal band and loop space maintainer

ACTIVE COMPARATOR

Stainless steel band and loop space maintainer will be made. Stainless steel appropriate band will be selected according to the size of the abutment teeth then design of the loop will be obtained, then will be send to the laboratory for soldering.

Device: CAD/CAM zircon band and loop space maintainer; Device: Conventional metal band and loop space maintainer

Interventions

CAD/CAM zircon band and loop space maintainer DEVICE

Solid monolithic zirconia material which utilizes CAD/CAM technology for its designing and milling of the restoration will be used for fabrication of the space maintainer.

Also known as: CAD/CAM space maintainer

Group 1(study group): CAD/CAM zircon band and loop space maintainer; Group 2(control): Conventional metal band and loop space maintainer

Conventional metal band and loop space maintainer DEVICE

Stainless steel appropriate band will be selected according to the size of the abutment teeth and then design of the loop will be obtained, then will be send to the laboratory for soldering.

Also known as: metal band and loop space maintainer

Group 1(study group): CAD/CAM zircon band and loop space maintainer; Group 2(control): Conventional metal band and loop space maintainer

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged :
• A-minimum:4years B-maximum: 7 years old
• Patients who are medically free
• Premature loss of bilateral primary molar.
• Sound and healthy buccal and lingual surfaces of selected primary molars.

You may not qualify if:

• Children with dental abnormalities (cross bite, open bite, and deep bite).
• Parafunctional oral habits.
• Carious lingual and buccal surfaces of primary molars.
• Lack of patient/parent compliance and cooperation.

Sponsors & Collaborators

• Ain Shams University: lead

Study Officials

• Gehan G. Allam, PHD

  Ain Shams Univesity

  STUDY CHAIR

Central Study Contacts

Sara A. Younes, MS

CONTACT

00201009334057; sarayounes87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant teacher

Model Details: Assignment

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 26, 2021
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share