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

Primary Purpose

Missing Teeth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mini-screw implant
removable partial denture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

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

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

Removable partial denture.

Arm Description

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

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

removable partial denture with conventional technique

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

vertical bone resorption
parallel technique using periapical radiograph
horizontal bone resorption
Cone beam computed tomography

Full Information

First Posted
October 3, 2023
Last Updated
October 16, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06082544
Brief Title
Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge
Arm Type
Experimental
Arm Description
Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge (horizontally placed) using JEIL SCREW 1.6*8 MM 16-G2-008
Arm Title
Mini screw implant supported pontics placed at the crest of the ridge
Arm Type
Experimental
Arm Description
Mini screw implant supported pontics placed at the crest of the ridge (vertically placed) using JEIL SCREW 1.6* 10 MM 14-G2-f010
Arm Title
Removable partial denture.
Arm Type
Active Comparator
Arm Description
removable partial denture with conventional technique
Intervention Type
Other
Intervention Name(s)
mini-screw implant
Intervention Description
JEIL SCREW 1.6* 8 MM 16-G2-008 or JEIL SCREW 1.6*10 MM 14-G2-010
Intervention Type
Device
Intervention Name(s)
removable partial denture
Intervention Description
Acrylic removable partial denture
Primary Outcome Measure Information:
Title
patient satisfaction
Description
visual analogue scale (VAS) continuous from 0-10 (0 not satisfied at all and 10 is satisfied)
Time Frame
3,6,9,12 months
Title
adverse effects
Description
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 Outcome Measure Information:
Title
vertical bone resorption
Description
parallel technique using periapical radiograph
Time Frame
1 year
Title
horizontal bone resorption
Description
Cone beam computed tomography
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman A Abdelhameed, MD
Phone
01002552228
Email
eman.adel@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Gihan M Abuelniel, PHD
Phone
01005886102
Email
gihan.abuelniel@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman A Abdelhameed, MD
Organizational Affiliation
Assistant lecturer at Pediatric Dentistry and Dental Public Health Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gihan M Abuelniel, PHD
Organizational Affiliation
Professor at Pediatric Dentistry and Dental Public Health Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed H El Khadem, PHD
Organizational Affiliation
Associate Professor at Pediatric Dentistry and Dental Public Health Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maii M Mohamed, PHD
Organizational Affiliation
Lecturer at Pediatric Dentistry and Dental Public Health Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed M Abdel Samad, PHD
Organizational Affiliation
Professor at Oral and Maxillofacial Radiology Department
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Giza
State/Province
Al Manial
ZIP/Postal Code
11562
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman A Abdelhameed, MD
Phone
01002552228
Email
eman.adel@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Gihan M Abuelniel, PHD
Email
Gihan.Abuelniel@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Eman A Abdelhameed, MD
First Name & Middle Initial & Last Name & Degree
Gihan M Abuelniel, PHD
First Name & Middle Initial & Last Name & Degree
Ahmed H El Khadem, PHD
First Name & Middle Initial & Last Name & Degree
Maii M Mohamed, PHD
First Name & Middle Initial & Last Name & Degree
Ahmed M Abdel Samad, PHD

12. IPD Sharing Statement

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

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