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

Missing Teeth Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06082544
• Other study ID #: 29208130101509
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Eman A Abdelhameed, MD
• Phone: 01002552228
• Email: eman.adel[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

Other:
• mini-screw implant
JEIL SCREW 1.6* 8 MM 16-G2-008 or JEIL SCREW 1.6*10 MM 14-G2-010

Device:
• removable partial denture
Acrylic removable partial denture

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Giza	Al Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction	visual analogue scale (VAS) continuous from 0-10 (0 not satisfied at all and 10 is satisfied)	3,6,9,12 months
Primary	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	vertical bone resorption	parallel technique using periapical radiograph	1 year
Secondary	horizontal bone resorption	Cone beam computed tomography	1 year