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

Clinical And Radiographic Success Of Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth: Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Missing Teeth
• Intervention / Treatment: Other: mini-screw implant; Device: removable partial denture

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman A Abdelhameed, MD; Phone Number: 01002552228; Email: eman.adel@dentistry.cu.edu.eg
• Study Contact Backup: Name: Gihan M Abuelniel, PHD; Phone Number: 01005886102; Email: gihan.abuelniel@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Al Manial
    • Giza, Al Manial, Egypt, 11562
      • Faculty of Dentistry, Cairo University
      • Contact: Eman A Abdelhameed, MD; Phone Number: 01002552228; Email: eman.adel@dentistry.cu.edu.eg
      • Contact: Gihan M Abuelniel, PHD; Email: Gihan.Abuelniel@dentistry.cu.edu.eg
      • Principal Investigator: Eman A Abdelhameed, MD
      • Sub-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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
patient satisfaction	visual analogue scale (VAS) continuous from 0-10 (0 not satisfied at all and 10 is satisfied)	3,6,9,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vertical bone resorption	parallel technique using periapical radiograph	1 year
horizontal bone resorption	Cone beam computed tomography	1 year

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: 29208130101509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No