Clinical Outcomes of Biologically Oriented Preparation Technique

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crowns; Tooth Preparation
• Intervention / Treatment: Procedure: Biologically-oriented preparation technique; Procedure: Conventional method of preparation

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abeer Aljareh, DDS MSc; Phone Number: 00963967873566; Email: abeer12.jareh@damascusuniversity.edu.sy
• Study Contact Backup: Name: Nabil Alhouri, DDS MSc PhD; Phone Number: 00963944597722; Email: nabil.alhouri@damascusuniversity.edu.sy

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Recruiting
    • Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
    • Contact: Nabil Alhouri, DDS MSc PhD; Phone Number: 00963944597722; Email: nabil.alhouri@damascusuniversity.edu.sy
    • Principal Investigator: Abeer Aljareh, DDS MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biologically-oriented preparation technique (BOPT); Patients in this group will undergo the biologically-oriented preparation technique.	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.
Active Comparator: Conventional preparation; Patients in this group will undergo the convention preparation technique.	Procedure: Conventional method of preparation; Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Plaque index	The plaque index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth, according to Löe and Silness, 1963	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
Change in the gingival index	The gingival index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth according to Silness and Löe, 1964	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
Change in the probing depth	A UNC periodontal probe will be used to measure the probing depth at the buccal, lingual, mesial, and distal sites of each included tooth.	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
Change in bleeding on probing	This variable will be measured at the buccal, lingual, mesial, and distal sites of each included tooth, recorded simultaneously with probing depth, according to Ainamo and Bay, 1975	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
Change in the gingival marginal stability	The gingival marginal stability at the buccal site will be measured using a UNC periodontal probe and a transparent jig to measure the distance between a reference point on the jig and the free gingival margin.	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
Change in the free gingiva thickness	The free gingiva thickness will be measured at the buccal site using a transparent jig with a reference point on the marginal gingiva, a 15-size spreader with a rubber stopper, and a millimetric ruler	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the internal and marginal adaptation	The internal and marginal adaptation will be dong using the replica technique. It will be carried out after clinical assessment and cementation of all crowns. An in vitro study utilizing an optical microscope with a micron-graded ruler will be implemented.	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the functional and mechanical complications	The functional and mechanical complications will be appraised. The existence of cracks, chipping, and/ or fracture of crowns and their size if exist according to FDI criteria (Hickel et al., 2010) will be evaluated.	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the secondary caries status	The secondary caries status will be assessed according to Cvar and Ryge, 2005. The presence or absence of caries at the cervical margins of the abutments will be recorded. Other biological complications, such as abutment fracture, root fracture, and/ or pulpitis will be reported, too	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the marginal adaptation after crown cementation	The marginal adaptation after crown cementation will be clinically evaluated using a sharp dental probe, according to Cvar and Ryge, 2005, at each follow-up appointment.	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the color matching	The level of color matching will be assessed according to Cvar and Ryge (2005). To measure this outcome, color matching with adjacent teeth, slight mismatching, or major mismatching of color and/or translucency will be reported.	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the clinical success	The clinical success status will be assessed according to Walton, 2002. This outcome will be evaluated in case any patient cannot attend the follow-up visits during the trial for any reason. Thus, success might be evaluated indirectly by a phone call if possible.	Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in patients' satisfaction	Patients' satisfaction will be assessed according to FDI criteria (Hickel et al., 2010). This outcome will report the level of patient satisfaction functionally and aesthetically. Complete satisfaction, light criticism, major criticism, and entirely dissatisfaction are the levels of the patient's view that will be described.	This will be measured at one week and 18 months following cementation.

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Abeer Aljareh, DDS MSc, Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria; Study Director: Nabil Alhouri, DDS MSc PhD, Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria; Study Director: Mohanad Kadhim, DDS MSc PhD, Department of Periodontology, Faculty of Dentistry, Iraq.

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UDDS-Prosthodontics-01-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No