Clinical Outcomes of Biologically Oriented Preparation Technique
NCT ID: NCT06496828
Last Updated: 2025-08-21
Study Results
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Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-30
2027-12-30
Brief Summary
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Detailed Description
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This randomized controlled trial will include 60 teeth divided into two groups: 30 teeth will be prepared with BOPT, and 30 teeth will be prepared with shoulder margins. All teeth will receive monolithic or bi-layered ceramic crowns.
Patients are planned to attend follow-up visits after 3, 6, 12, and 18 months, respectively, after cementation. Probing depth, gingival recession, bleeding on probing, gingival index, gingival thickness, patient opinion, and mechanical and biological complications are all recorded at check-up appointments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Biologically-oriented preparation technique (BOPT)
Patients in this group will undergo the biologically-oriented preparation technique.
Biologically-oriented preparation technique
The preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns.
Conventional preparation
Patients in this group will undergo the convention preparation technique.
Conventional method of preparation
Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns
Interventions
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Biologically-oriented preparation technique
The preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns.
Conventional method of preparation
Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns
Eligibility Criteria
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Inclusion Criteria
* Two teeth at least needed to be restored with full crowns (each patient needs at least two single crowns).
* Stable occlusion.
* Good oral hygiene.
* Periodontally healthy teeth.
* Nonsmoking or smoking less than ten cigarettes/day.
* Probing depth between 1 and 3 mm.
Exclusion Criteria
* Parafunctional habits.
* Active periodontal disease.
* Poor oral hygiene.
* Systemic disease that may affect the periodontal health.
* Pregnancy.
* Radiation or chemotherapy.
* Treatment by Bisphosphonates medication.
* Patients who are unable or unwilling to attend follow-up visits
19 Years
80 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Abeer Aljareh, DDS MSc
Role: PRINCIPAL_INVESTIGATOR
Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Nabil Alhouri, DDS MSc PhD
Role: STUDY_DIRECTOR
Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Mohanad Kadhim, DDS MSc PhD
Role: STUDY_DIRECTOR
Department of Periodontology, Faculty of Dentistry, Iraq.
Locations
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Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Damascus, , Syria
Countries
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Central Contacts
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Facility Contacts
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References
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Mohammad A, Abraham S, Nada A. The effect of biologically oriented and subgingival horizontal preparation techniques on periodontal health: A double-blind randomized controlled clinical trial. Saudi Dent J. 2023 Sep;35(6):727-733. doi: 10.1016/j.sdentj.2023.06.003. Epub 2023 Jun 17.
Palombo D, Rahmati M, Vignoletti F, Sanz-Esporrin J, Salido MP, Haugen HJ, Sanz M. Hard and soft tissue healing around teeth prepared with the biologically oriented preparation technique and restored with provisional crowns: An in vivo experimental investigation. J Clin Periodontol. 2023 Sep;50(9):1217-1238. doi: 10.1111/jcpe.13825. Epub 2023 May 30.
Agustin-Panadero R, Serra-Pastor B, Loi I, Suarez MJ, Pelaez J, Sola-Ruiz F. Clinical behavior of posterior fixed partial dentures with a biologically oriented preparation technique: A 5-year randomized controlled clinical trial. J Prosthet Dent. 2021 Jun;125(6):870-876. doi: 10.1016/j.prosdent.2020.03.031. Epub 2020 Jun 21.
Serra-Pastor B, Bustamante-Hernandez N, Fons-Font A, Fernanda Sola-Ruiz M, Revilla-Leon M, Agustin-Panadero R. Periodontal Behavior and Patient Satisfaction of Anterior Teeth Restored with Single Zirconia Crowns Using a Biologically Oriented Preparation Technique: A 6-Year Prospective Clinical Study. J Clin Med. 2021 Aug 6;10(16):3482. doi: 10.3390/jcm10163482.
Agustin-Panadero R, Serra-Pastor B, Fons-Font A, Sola-Ruiz MF. Prospective Clinical Study of Zirconia Full-coverage Restorations on Teeth Prepared With Biologically Oriented Preparation Technique on Gingival Health: Results After Two-year Follow-up. Oper Dent. 2018 Sep/Oct;43(5):482-487. doi: 10.2341/17-124-C. Epub 2018 Mar 7.
Paniz G, Nart J, Gobbato L, Chierico A, Lops D, Michalakis K. Periodontal response to two different subgingival restorative margin designs: a 12-month randomized clinical trial. Clin Oral Investig. 2016 Jul;20(6):1243-52. doi: 10.1007/s00784-015-1616-z. Epub 2015 Oct 8.
Loi I, Di Felice A. Biologically oriented preparation technique (BOPT): a new approach for prosthetic restoration of periodontically healthy teeth. Eur J Esthet Dent. 2013 Spring;8(1):10-23.
Other Identifiers
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UDDS-Prosthodontics-01-2024
Identifier Type: -
Identifier Source: org_study_id
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