Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth

Study Overview
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Brief Summary
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Loss of teeth leads to loss of function and lack of normal alveolar growth, along with unpleasant esthetics that hamper the psychosocial development of the young child. Traditionally, the management of single tooth loss in a young child is done by conservative means. The presence of large pulp chambers in incompletely mineralized immature teeth of children predisposes the pulp to loss of vitality in cases of complete coverage restorations . Hence, the clinician resorts to partial coverage prostheses such as Maryland Bridge, resin-bonded restorations, or removable prostheses in cases of multiple missing teeth. None of these treatment methods are completely satisfactory and have their drawbacks. Partial dentures are dependent on the child's compliance. They increase the rate of decay and may cause gingival disease leading to bone resorption. Furthermore, there is a need to refabricate a new prosthesis from time to time to compensate for craniofacial growth. Mini-screw implant placement in a young child would be an ideal method of treatment for the absence of teeth. They restore the function, preserve the alveolar bone, and give excellent esthetics, restoring the child's confidence and social acceptability. Parents are usually keen to get this treatment done as soon as offer the suggestion. To our knowledge, there is no previous study that compared the two techniques. The limited evidence shows that mini-screw implants supported pontics are useful transitional restorations for missing permanent maxillary incisors in children and adolescents; however, further well-designed clinical trials are needed in this regard. As a result, this study will be conducted to fill the gap of knowledge.

Detailed Description
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Rationale for conducting the research Mini- screw implant prosthetic rehabilitation seems to be a viable and promising option for provisional rehabilitation of growing patients, since it seems to preserve the bone structure while restoring function and esthetics until growth ceases, when then mini-screw implants can be replaced by standard implants. Benefits for the practitioner: Providing new and alternative treatment options for restoring missing permanent anterior teeth with fixed mini-screw implant supported pontics. Increasing the compliance of the patients. Benefits for the patient: Re-establish esthetic and appearance. Maintenance of space. Re-establishing occlusal relationships. Improving phonetics. Improving patients tolerance. Improvement in patient as well as parent satisfaction. Benefits for community: Using alternative technique that can be fixed, with a better success rate. To boost overall oral health.

Official Title
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Clinical And Radiographic Success Of Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth: Randomized Clinical Trial

Conditions
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Missing Teeth

Intervention / Treatment
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* Other: mini-screw implant
* Device: removable partial denture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Cooperative children. 9:14 years old children. Children with missing anterior permanent teeth either due to caries, trauma (at least 4 months after missing the tooth) or congenitally missed. Exclusion Criteria: Children with physical or emotional alteration. Children with systemic diseases. Children of parents who don't accept to participate in the study. Very thin ridge

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge<br>Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge (horizontally placed) using JEIL SCREW 1.6*8 MM 16-G2-008 | Other: mini-screw implant<br>* JEIL SCREW 1.6* 8 MM 16-G2-008 or JEIL SCREW 1.6*10 MM 14-G2-010<br>|
| Experimental: Mini screw implant supported pontics placed at the crest of the ridge<br>Mini screw implant supported pontics placed at the crest of the ridge (vertically placed) using JEIL SCREW 1.6* 10 MM 14-G2-f010 | Other: mini-screw implant<br>* JEIL SCREW 1.6* 8 MM 16-G2-008 or JEIL SCREW 1.6*10 MM 14-G2-010<br>|
| Active Comparator: Removable partial denture.<br>removable partial denture with conventional technique | Device: removable partial denture<br>* Acrylic removable partial denture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | visual analogue scale (VAS) continuous from 0-10 (0 not satisfied at all and 10 is satisfied) | 3,6,9,12 months | 
| adverse effects | denture fracture, denture loss, denture remake, looseness of the screw, fracture of the screw, pontic displacement, fracture of the pontic and discoloration of the pontic | 3,6,9,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertical bone resorption | parallel technique using periapical radiograph | 1 year | 
| horizontal bone resorption | Cone beam computed tomography | 1 year |