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Recruiting NCT06496828

Clinical Outcomes of Biologically Oriented Preparation Technique

No phase Interventional Crowns Tooth Preparation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biologically-oriented preparation technique, Conventional method of preparation.
Who it may be relevant to
Registry conditions: Crowns, Tooth Preparation. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Syria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation

Overview

This study aims to evaluate the periodontal response of teeth prepared with a biologically oriented preparation technique (BOPT) compared to conventional preparation for all-ceramic crowns.

Detailed description

The study aims to evaluate the clinical performance of all-ceramic crowns on teeth prepared with two different types of preparations.

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.

Interventions

  • Procedure 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.
  • Procedure Conventional method of preparation
    Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns

Primary outcome measures

  • Change in the Plaque index [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the gingival index [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the probing depth [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in bleeding on probing [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the gingival marginal stability [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the free gingiva thickness [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
Secondary outcome measures (7)
  • Change in the internal and marginal adaptation [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the functional and mechanical complications [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the secondary caries status [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the marginal adaptation after crown cementation [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the color matching [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the clinical success [Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in patients' satisfaction [Time frame: This will be measured at one week and 18 months following cementation.]

Eligibility criteria

Inclusion criteria

  • Patients older than 18.
  • 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

  • Patients younger than 18.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Syria · 1 center
  • Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria — Damascus

Publications

  • 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. PMID 37817795
  • 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. PMID 37253614
  • 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. PMID 32580920
  • 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. PMID 34441778
  • 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. PMID 29513640
  • 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. PMID 26445857
  • 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. PMID 23390618

Identifiers

NCT: NCT06496828 · UDDS-Prosthodontics-01-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗