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

NCT05350293 | Completed DMC

• 1 other identifier: UDDS-Ortho-08-2022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth

Keywords

dental implant; 3D printed abutment; molded abutment

Outcome Measures

Primary Outcomes (1)

• 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.

  T1:3 months after cementation, T2: 6 months after cementation, T3: 1 year after cementation

Secondary Outcomes (1)

• Change in the depth of periodontal pockets

  T1: direct after cementation, T2:3 months after cementation, T3: 6 months after cementation, T4: 1 year after cementation

Study Arms (2)

Molded abutment

ACTIVE COMPARATOR

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.

Other: Molded abutment

3D printed abutment

EXPERIMENTAL

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

Other: 3D printed abutment

Interventions

Molded abutment OTHER

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.

Molded abutment

3D printed abutment OTHER

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.

3D printed abutment

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (5)

• 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.

  PMID: 32469723 BACKGROUND

• 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.

  PMID: 33114737 BACKGROUND

• 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.

  PMID: 31027960 BACKGROUND

• 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.

  PMID: 33284906 BACKGROUND

• 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.

  PMID: 34529710 BACKGROUND

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mohammad Anas Almodalal, DDS,MSc

  Department of fixed prosthodontics , Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Luai Morad, DDS,MSc,PhD

  Department of fixed prosthodontics , Damascus University, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: September 2, 2020
• Primary Completion: December 11, 2021
• Study Completion: March 23, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)