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Completed

NCT Number: NCT05350293

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

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.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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 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 outcomes

  1. Change in the depth of periodontal pockets

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

    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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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