Premature Tooth Exfoliation
Conditions
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
Detailed description
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.
Interventions
DEVICEPrefabricated band and loop
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.
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
A randomized controlled clinical trial, parallel group, allocation ratio 1:1 Framework superiority
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Health | 3 month and 9 month | 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 |
| Cement integrity | 3 month and 9 month | Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Space loss between the abutment teeth. | 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: | 0 month and 9 month | 1. Arch perimeter: Measured on digital cast as a sum of the incisor, canine and molar segment widths in mm. 2. 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. 3. 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. |
Countries
Egypt
Contacts
Primary ContactLamis A Badawi
Backup ContactSherif B Eltaweil, Professor
Outcome results
None listed