Cairo university
Cairo, Egypt
Not Yet Recruiting
NCT Number: NCT06573463
Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers
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
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
4 year–6 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Prefabricated band and loop
DevicePrefabricated 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
Conventional Band and loop
DeviceConventional 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.
Primary outcomes
-
Gingival Health
Time frame: 3 month and 9 month
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
-
Cement integrity
Time frame: 3 month and 9 month
Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No)
Secondary outcomes
-
Space loss between the abutment teeth.
Time frame: 0 month and 9 month
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.
-
Change in arch dimension:
Time frame: 0 month and 9 month
- 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Lamis A Badawi
CONTACT
Sherif B Eltaweil, Professor
CONTACT
Sponsors and collaborators
Lead sponsor
Cairo University
Other
Registry information
Official study title
Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 27, 2024
- Registry last updated
- Aug 28, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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