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

NCT06082544 | Unknown

• 1 other identifier: 29208130101509
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• vertical bone resorption

  1 year

• horizontal bone resorption

  1 year

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Removable partial denture.

ACTIVE COMPARATOR

removable partial denture with conventional technique

Device: removable partial denture

Interventions

mini-screw implant 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 palatally perpendicular to the alveolar ridge

removable partial denture DEVICE

Acrylic removable partial denture

Removable partial denture.

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative children.
• :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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Giza, Al Manial, 11562, Egypt

Location

MeSH Terms

Conditions

Anodontia

Interventions

Denture, Partial, Removable

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Denture, Partial; Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Eman A Abdelhameed, MD

  Assistant lecturer at Pediatric Dentistry and Dental Public Health Department

  PRINCIPAL INVESTIGATOR

• Gihan M Abuelniel, PHD

  Professor at Pediatric Dentistry and Dental Public Health Department

  STUDY DIRECTOR

• Ahmed H El Khadem, PHD

  Associate Professor at Pediatric Dentistry and Dental Public Health Department

  STUDY DIRECTOR

• Maii M Mohamed, PHD

  Lecturer at Pediatric Dentistry and Dental Public Health Department

  STUDY DIRECTOR

• Ahmed M Abdel Samad, PHD

  Professor at Oral and Maxillofacial Radiology Department

  STUDY DIRECTOR

Central Study Contacts

Eman A Abdelhameed, MD

CONTACT

01002552228; eman.adel@dentistry.cu.edu.eg

Gihan M Abuelniel, PHD

CONTACT

01005886102; gihan.abuelniel@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer in the department of pediatric dentistry

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 13, 2023
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

EG (1)