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

NCT ID: NCT06082544

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-09-01

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.

Conditions

Missing Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge

Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge (horizontally placed) using JEIL SCREW 1.6\*8 MM 16-G2-008

Group Type: EXPERIMENTAL

mini-screw implant

Intervention Type: OTHER

JEIL SCREW 1.6\* 8 MM 16-G2-008 or JEIL SCREW 1.6\*10 MM 14-G2-010

Mini screw implant supported pontics placed at the crest of the ridge

Mini screw implant supported pontics placed at the crest of the ridge (vertically placed) using JEIL SCREW 1.6\* 10 MM 14-G2-f010

Group Type: EXPERIMENTAL

mini-screw implant

Intervention Type: OTHER

JEIL SCREW 1.6\* 8 MM 16-G2-008 or JEIL SCREW 1.6\*10 MM 14-G2-010

Removable partial denture.

removable partial denture with conventional technique

Group Type: ACTIVE_COMPARATOR

removable partial denture

Intervention Type: DEVICE

Acrylic removable partial denture

Interventions

mini-screw implant

JEIL SCREW 1.6\* 8 MM 16-G2-008 or JEIL SCREW 1.6\*10 MM 14-G2-010

Intervention Type: OTHER

removable partial denture

Acrylic removable partial denture

Intervention Type: DEVICE

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eman Adel Abd Elhameed

assistant lecturer in the department of pediatric dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman A Abdelhameed, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer at Pediatric Dentistry and Dental Public Health Department

Gihan M Abuelniel, PHD

Role: STUDY_DIRECTOR

Professor at Pediatric Dentistry and Dental Public Health Department

Ahmed H El Khadem, PHD

Role: STUDY_DIRECTOR

Associate Professor at Pediatric Dentistry and Dental Public Health Department

Maii M Mohamed, PHD

Role: STUDY_DIRECTOR

Lecturer at Pediatric Dentistry and Dental Public Health Department

Ahmed M Abdel Samad, PHD

Role: STUDY_DIRECTOR

Professor at Oral and Maxillofacial Radiology Department

Locations

Faculty of Dentistry, Cairo University

Giza, Al Manial, Egypt

Countries

Egypt

Central Contacts

Eman A Abdelhameed, MD

Role: CONTACT

eman.adel@dentistry.cu.edu.eg

01002552228

Gihan M Abuelniel, PHD

Role: CONTACT

gihan.abuelniel@dentistry.cu.edu.eg

01005886102

Facility Contacts

Eman A Abdelhameed, MD

Role: primary

eman.adel@dentistry.cu.edu.eg

01002552228

Gihan M Abuelniel, PHD

Role: backup

Gihan.Abuelniel@dentistry.cu.edu.eg

Other Identifiers

29208130101509

Identifier Type: -

Identifier Source: org_study_id