Clinical trial NCT05350293: 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
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Keywords: dental implant
3D printed abutment
molded abutment
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the crestal bone height
timeFrame: T1:3 months after cementation, T2: 6 months after cementation, T3: 1 year after cementation
Secondary outcomes:
measure: Change in the depth of periodontal pockets
timeFrame: T1: direct after cementation, T2:3 months after cementation, T3: 6 months after cementation, T4: 1 year after cementation
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of fixed prosthodontics , Damascus University, Syria
name: Mohammad Anas Almodalal, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of fixed prosthodontics , Damascus University, Syria
name: Mohammad Luai Morad, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.