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Missing TeethNCT05350293

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

A study testing Molded abutment and 3D printed abutment in people with Missing Teeth, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Missing Teeth
What is being tested?
Molded abutment and 3D printed abutment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSyria
Study dates
2 Sep 2020to 23 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • University of Damascus

    Damascus

Other trials in Syria

About this study

Official title: Evaluation of Two Different Types of Abutments on Post-prosthesis Bone Resorption: A Randomized Controlled Clinical and Radiological Trial

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.

Read the 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.

Conditions
Missing Teeth
Being tested
Molded abutment, 3D printed abutment
Keywords
dental implant, 3D printed abutment, molded abutment
Medical subject headings
Anodontia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Molded abutmentOther

    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.

  • 3D printed abutmentOther

    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.

Study groups in NCT05350293
Study groupRoleWhat they receive
Molded abutmentActive comparatorA 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.
Receives: Other: Molded abutment
3D printed abutmentExperimentalThe customised abutment will be made using a laser printer with a Cr-Co mixture after being designed using a special computer program.
Receives: Other: 3D printed abutment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start2 Sep 2020
  3. Primary completion11 Dec 2021
  4. Study completion23 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05350293
Sponsor's protocol ID
UDDS-Ortho-08-2022
Status last verified
Apr 2022
First submitted
22 Apr 2022
Last updated
4 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32469723

  • 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.

    PubMed 33114737

  • 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.

    PubMed 31027960

  • 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.

    PubMed 33284906

  • 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.

    PubMed 34529710

Questions about this trial

What is this clinical trial studying?

A study testing Molded abutment and 3D printed abutment in people with Missing Teeth, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the crestal bone height (time frame: T1:3 months after cementation, T2: 6 months after cementation, T3: 1 year after cementation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05350293, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.

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