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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06082544
Collaborator
(none)
36
1
3
20
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mini-screw implant
  • Device: removable partial denture
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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
JEIL SCREW 1.6* 8 MM 16-G2-008 or JEIL SCREW 1.6*10 MM 14-G2-010

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

Active Comparator: Removable partial denture.

removable partial denture with conventional technique

Device: removable partial denture
Acrylic removable partial denture

Outcome Measures

Primary Outcome Measures

  1. patient satisfaction [3,6,9,12 months]

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

  2. adverse effects [3,6,9,12 months]

    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

Secondary Outcome Measures

  1. vertical bone resorption [1 year]

    parallel technique using periapical radiograph

  2. horizontal bone resorption [1 year]

    Cone beam computed tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 14 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Cairo University Giza Al Manial Egypt 11562

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Eman A Abdelhameed, MD, Assistant lecturer at Pediatric Dentistry and Dental Public Health Department
  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eman Adel Abd Elhameed, assistant lecturer in the department of pediatric dentistry, Cairo University
ClinicalTrials.gov Identifier:
NCT06082544
Other Study ID Numbers:
  • 29208130101509
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2023