Clinical trial NCT06082544: Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth
Official title: Clinical And Radiographic Success Of Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Missing Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 36
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: patient satisfaction
timeFrame: 3,6,9,12 months
measure: adverse effects
timeFrame: 3,6,9,12 months
Secondary outcomes:
measure: vertical bone resorption
timeFrame: 1 year
measure: horizontal bone resorption
timeFrame: 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Al Manial
Study officials:
affiliation: Assistant lecturer at Pediatric Dentistry and Dental Public Health Department
name: Eman A Abdelhameed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor at Pediatric Dentistry and Dental Public Health Department
name: Gihan M Abuelniel, PHD
role: STUDY_DIRECTOR
affiliation: Associate Professor at Pediatric Dentistry and Dental Public Health Department
name: Ahmed H El Khadem, PHD
role: STUDY_DIRECTOR
affiliation: Lecturer at Pediatric Dentistry and Dental Public Health Department
name: Maii M Mohamed, PHD
role: STUDY_DIRECTOR
affiliation: Professor at Oral and Maxillofacial Radiology Department
name: Ahmed M Abdel Samad, PHD
role: STUDY_DIRECTOR
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