"Evaluation of Clinical Performance and Success Rate of CAD/CAM Versus Conventional Band and Loop Space Maintainer Randomized Clinical Trial and in Vitro Study"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 18
- Primary Endpoint
- The success rate of appliances in terms of survival time.
Study Overview
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
Detailed Description
Introduction:
Primary teeth play an important role in the development and growth of a child. Although their role in esthetics, speech, eating, and to encourage normal function. The other main function of a primary tooth is to hold space for the permanent successor until it's time for eruption. This normal physiologic process can be affected due to early premature loss of primary molars, due to dental caries which may lead to mesial tipping or migration of large permanent molar teeth into the space created. This may result in loss of space leading to discrepancy of arch length, malocclusion, crowding of teeth, cross bite, impaction of permanent premolars, and supra-eruption of opposing tooth. The best approach to maintain arch space and to prevent malocclusion is to use a space maintainer. Band and loop has been used since long as a space maintainer with high success rates. But there are some disadvantages can be associated with space maintainers which include, loss of cement, solder failure, caries formation along the margins of the band, long construction time, and the possibility of metal allergy in some patients. These shortcomings in addition to the rising interest of esthetic dentistry augmented by advances in technology have led to the development of newer materials and designs in the fabrication of space maintainers such as fiber-reinforced composite resins (FRCR) as fixed space maintainers. Digital technologies such as CAD CAM technology and new materials are becoming popular, getting better and changing the way to therapy. The ceramic space maintainer seems to be a suitable alternative to the conventional band and loop space maintainer. The appliance is well tolerated by the patient and also gives the benefit of advanced aesthetics with improved strength and allowing the easiest way of debonding during eruption of permanent successors.
The aim of the current study is:
A) Primary Objective Evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits (Plaque index), gingival health (Gingival index).
The success rate of appliances in terms of survival time, cement loss and appliance breakage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Double
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Group 1(study group): CAD/CAM zircon band and loop space maintainer
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.
Intervention: CAD/CAM zircon band and loop space maintainer (Device)
Group 1(study group): CAD/CAM zircon band and loop space maintainer
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.
Intervention: Conventional metal band and loop space maintainer (Device)
Group 2(control): Conventional metal band and loop space maintainer
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.
Intervention: CAD/CAM zircon band and loop space maintainer (Device)
Group 2(control): Conventional metal band and loop space maintainer
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.
Intervention: Conventional metal band and loop space maintainer (Device)
Outcomes
Primary Outcomes
The success rate of appliances in terms of survival time.
Time Frame: Up to 12 months
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.
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)
Time Frame: Up to 12 months
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.
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.
Time Frame: up to 12 months
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.
Secondary Outcomes
- Compare both appliances in terms of patient satisfaction.(Up to 12 months)
Investigators
sara Abdelkhalek hassan younes
assistant teacher
Ain Shams University