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Evaluation of the Abutment Type Following Oral Implants in Terms of the Surrounding Bone Height

Primary Purpose

Missing Teeth

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Molded abutment
3D printed abutment
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth focused on measuring dental implant, 3D printed abutment, molded abutment

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient's age is greater than 20 years and younger than 50
  • Good oral health
  • Absence of systemic diseases that may affect the healing of surrounding tissues, such as diabetes.

Exclusion Criteria:

  • The presence of non-functional habits such as stridor
  • Acute or acute periodontitis, previous loss of implants
  • Poor general health conditions
  • Previous radiotherapy in the head and neck area
  • Mental incompetence
  • Orthodontic treatment

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Molded abutment

3D printed abutment

Arm Description

A plastic abutment that is provided by the implant manufacturer will be used. This abutment will be modified using wax, and then it will be dismantled, wedged, and poured using a Ni-Cr mixture. A plastic abutment that the implant manufacturer provides will be used. This abutment will be modified using wax, and then it will be dismantled, wedged, and poured using a Ni-Cr mixture.

The customised abutment will be made using a laser printer with a Cr-Co mixture after being designed using a special computer program.

Outcomes

Primary Outcome Measures

Change in the crestal bone height
It Is the loss of bone that occurred around the dental implant neck after fixing the final prosthesis (abutment and crown). A periapical radiograph is going to be taken using a digital intra-oral sensor with a special holder in a parallel way, to measure the changes that occurred at the level of the bone around the implant depending on MBLS concept taking two referring points from the neck of the abutment to the first match of the bone with the abutment using special programs on computer (Photoshop) during different periods.

Secondary Outcome Measures

Change in the depth of periodontal pockets
Periodontal pockets are spaces surrounding the implant under the gum line. The pocket around the implant will be measured by using special plastic probe slides between the implant and gum to measure the depth of the periodontal pocket, and the changes in the depth of pockets will be noted and register after fixing the final prosthesis (abutment and crown), during different periods.

Full Information

First Posted
April 22, 2022
Last Updated
April 28, 2022
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05350293
Brief Title
Evaluation of the Abutment Type Following Oral Implants in Terms of the Surrounding Bone Height
Official Title
Evaluation of Two Different Types of Abutments on Post-prosthesis Bone Resorption: A Randomized Controlled Clinical and Radiological Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
December 11, 2021 (Actual)
Study Completion Date
March 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compare two different types of abutments (molded abutments and computer-designed 3D printed abutments) in terms of the amount of bone loss, and depth of periodontal pockets around the implant during different periods.
Detailed Description
In the past few years, the number of research conducted on the designs of abutments and materials has increased. Often, the restoration is done over the implant using standard abutments that the implant company prefabricated, but due to the problems facing the dentist from the occurrence of bone absorption, an increase in the depth of the pocket after restoration, other types of abutment design methods have been introduced as needed (molded abutment made by lost wax technique and computer-designed abutment made using a 3D laser printer), those customised abutments were made special for each patient depending on their conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
Keywords
dental implant, 3D printed abutment, molded abutment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Molded abutment
Arm Type
Active Comparator
Arm Description
A plastic abutment that is provided by the implant manufacturer will be used. This abutment will be modified using wax, and then it will be dismantled, wedged, and poured using a Ni-Cr mixture. A plastic abutment that the implant manufacturer provides will be used. This abutment will be modified using wax, and then it will be dismantled, wedged, and poured using a Ni-Cr mixture.
Arm Title
3D printed abutment
Arm Type
Experimental
Arm Description
The customised abutment will be made using a laser printer with a Cr-Co mixture after being designed using a special computer program.
Intervention Type
Other
Intervention Name(s)
Molded abutment
Intervention Description
The waxed plastic abutment will dismantle, wedged, and poured using a Ni-Cr mixture then it will be trimmed to make it ready to make the permanent restoration over it. The prostheses will be cemented above the abutment using dual-cure resin cement then the final restoration (crown and abutment) will be fixed using a screw-retained manner.
Intervention Type
Other
Intervention Name(s)
3D printed abutment
Intervention Description
A marker or Scan body appropriate for the type of implant will be placed on the laboratory implant substitute, a digital scan of the marker will be done in the lab, and the scanned image will be transferred to a computer design software where the prosthesis is designed, In the printing phase, the final prosthesis will be manufactured using a stepwise metal powder supply and a laser fusion process. Making the abutment ready to make the permanent restoration over it. The prostheses will be cemented above the abutment using dual-cure resin cement then the final restoration (crown and abutment) will be fixed using a screw-retained manner.
Primary Outcome Measure Information:
Title
Change in the crestal bone height
Description
It Is the loss of bone that occurred around the dental implant neck after fixing the final prosthesis (abutment and crown). A periapical radiograph is going to be taken using a digital intra-oral sensor with a special holder in a parallel way, to measure the changes that occurred at the level of the bone around the implant depending on MBLS concept taking two referring points from the neck of the abutment to the first match of the bone with the abutment using special programs on computer (Photoshop) during different periods.
Time Frame
T1:3 months after cementation, T2: 6 months after cementation, T3: 1 year after cementation
Secondary Outcome Measure Information:
Title
Change in the depth of periodontal pockets
Description
Periodontal pockets are spaces surrounding the implant under the gum line. The pocket around the implant will be measured by using special plastic probe slides between the implant and gum to measure the depth of the periodontal pocket, and the changes in the depth of pockets will be noted and register after fixing the final prosthesis (abutment and crown), during different periods.
Time Frame
T1: direct after cementation, T2:3 months after cementation, T3: 6 months after cementation, T4: 1 year after cementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient's age is greater than 20 years and younger than 50 Good oral health Absence of systemic diseases that may affect the healing of surrounding tissues, such as diabetes. Exclusion Criteria: The presence of non-functional habits such as stridor Acute or acute periodontitis, previous loss of implants Poor general health conditions Previous radiotherapy in the head and neck area Mental incompetence Orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Anas Almodalal, DDS,MSc
Organizational Affiliation
Department of fixed prosthodontics , Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Luai Morad, DDS,MSc,PhD
Organizational Affiliation
Department of fixed prosthodontics , Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32469723
Citation
Barbin T, Veloso DV, Del Rio Silva L, Borges GA, Presotto AGC, Barao VAR, Mesquita MF. 3D metal printing in dentistry: An in vitro biomechanical comparative study of two additive manufacturing technologies for full-arch implant-supported prostheses. J Mech Behav Biomed Mater. 2020 Aug;108:103821. doi: 10.1016/j.jmbbm.2020.103821. Epub 2020 Apr 27.
Results Reference
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PubMed Identifier
33114737
Citation
Bae S, Hong MH, Lee H, Lee CH, Hong M, Lee J, Lee DH. Reliability of Metal 3D Printing with Respect to the Marginal Fit of Fixed Dental Prostheses: A Systematic Review and Meta-Analysis. Materials (Basel). 2020 Oct 26;13(21):4781. doi: 10.3390/ma13214781.
Results Reference
background
PubMed Identifier
31027960
Citation
Jang Y, Sim JY, Park JK, Kim WC, Kim HY, Kim JH. Accuracy of 3-unit fixed dental prostheses fabricated on 3D-printed casts. J Prosthet Dent. 2020 Jan;123(1):135-142. doi: 10.1016/j.prosdent.2018.11.004. Epub 2019 Apr 23.
Results Reference
background
PubMed Identifier
33284906
Citation
Ramalho I, Witek L, Coelho PG, Bergamo E, Pegoraro LF, Bonfante EA. Influence of Abutment Fabrication Method on 3D Fit at the Implant-Abutment Connection. Int J Prosthodont. 2020 Nov/Dec;33(6):641-647. doi: 10.11607/ijp.6574.
Results Reference
background
PubMed Identifier
34529710
Citation
Chou WT, Chuang CC, Wang YB, Chiu HC. Comparison of the internal fit of metal crowns fabricated by traditional casting, computer numerical control milling, and three-dimensional printing. PLoS One. 2021 Sep 16;16(9):e0257158. doi: 10.1371/journal.pone.0257158. eCollection 2021.
Results Reference
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Evaluation of the Abutment Type Following Oral Implants in Terms of the Surrounding Bone Height

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