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Not yet recruitingNCT06082544Updated Oct 18, 2023

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

An interventional study of mini-screw implant and removable partial denture in Missing Teeth, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
9 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Missing Teeth
03

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    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

    Other: mini-screw implant

  • Experimental
    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

    Other: mini-screw implant

  • Active comparator
    Removable partial denture.

    removable partial denture with conventional technique

    Device: removable partial denture

Interventions

  • Othermini-screw implant

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

  • Deviceremovable partial denture

    Acrylic removable partial denture

05

What researchers measure

Primary outcomes

  1. patient satisfaction

    visual analogue scale (VAS) continuous from 0-10 (0 not satisfied at all and 10 is satisfied)

    Time frame: 3,6,9,12 months

  2. 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

    Time frame: 3,6,9,12 months

Secondary outcomes

  1. vertical bone resorption

    parallel technique using periapical radiograph

    Time frame: 1 year

  2. horizontal bone resorption

    Cone beam computed tomography

    Time frame: 1 year

06

Study locations

1 site
  • Faculty of Dentistry, Cairo University
    Giza, Al Manial 11562, Egypt
    • Eman A Abdelhameed, MD · Contact · eman.adel@dentistry.cu.edu.eg · 01002552228
    • Gihan M Abuelniel, PHD · Contact · Gihan.Abuelniel@dentistry.cu.edu.eg
    • Eman A Abdelhameed, MD · Principal investigator
    • Gihan M Abuelniel, PHD · Sub investigator
    • Ahmed H El Khadem, PHD · Sub investigator
    • Maii M Mohamed, PHD · Sub investigator
    • Ahmed M Abdel Samad, PHD · Sub investigator
07

Registry details

Key details

Study ID
NCT06082544
Lead sponsor
Cairo University
Responsible party
Eman Adel Abd Elhameed (assistant lecturer in the department of pediatric dentistry, Cairo University) — Principal investigator
First posted
Oct 13, 2023
Start date
Jan 1, 2024 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Oct 18, 2023

Study contacts

Eman A Abdelhameed, MD
Contact
eman.adel@dentistry.cu.edu.eg
01002552228
Gihan M Abuelniel, PHD
Contact
gihan.abuelniel@dentistry.cu.edu.eg
01005886102
Eman A Abdelhameed, MD
principal investigator · Assistant lecturer at Pediatric Dentistry and Dental Public Health Department
Gihan M Abuelniel, PHD
study director · Professor at Pediatric Dentistry and Dental Public Health Department
Ahmed H El Khadem, PHD
study director · Associate Professor at Pediatric Dentistry and Dental Public Health Department
Maii M Mohamed, PHD
study director · Lecturer at Pediatric Dentistry and Dental Public Health Department
Ahmed M Abdel Samad, PHD
study director · Professor at Oral and Maxillofacial Radiology Department

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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