Clinical trial NCT06496828: Clinical Outcomes of Biologically Oriented Preparation Technique
Official title: Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crowns
Tooth Preparation
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change in the Plaque index
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
measure: Change in the gingival index
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
measure: Change in the probing depth
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
measure: Change in bleeding on probing
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
measure: Change in the gingival marginal stability
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
measure: Change in the free gingiva thickness
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
Secondary outcomes:
measure: Change in the internal and marginal adaptation
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
measure: Change in the functional and mechanical complications
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
measure: Change in the secondary caries status
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
measure: Change in the marginal adaptation after crown cementation
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
measure: Change in the color matching
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
measure: Change in the clinical success
timeFrame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
measure: Change in patients' satisfaction
timeFrame: This will be measured at one week and 18 months following cementation.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Study officials:
affiliation: Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Abeer Aljareh, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Nabil Alhouri, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Department of Periodontology, Faculty of Dentistry, Iraq.
name: Mohanad Kadhim, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.