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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologically-oriented preparation technique (BOPT) | Experimental | Patients in this group will undergo the biologically-oriented preparation technique. |
|
| Conventional preparation | Active Comparator | Patients in this group will undergo the convention preparation technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologically-oriented preparation technique | Procedure | The preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abeer Aljareh, DDS MSc | Contact | 00963967873566 | abeer12.jareh@damascusuniversity.edu.sy | |
| Nabil Alhouri, DDS MSc PhD | Contact | 00963944597722 | nabil.alhouri@damascusuniversity.edu.sy |
| Name | Affiliation | Role |
|---|---|---|
| Abeer Aljareh, DDS MSc | Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria | Principal Investigator |
| Nabil Alhouri, DDS MSc PhD | Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria | Recruiting | Damascus | DM20AM18 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37817795 | Background | 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. | |
| 37253614 | Background | 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. |
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| Conventional method of preparation | Procedure | Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns |
|
| Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns. |
| 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. |
| Study Director |
| Mohanad Kadhim, DDS MSc PhD | Department of Periodontology, Faculty of Dentistry, Iraq. | Study Director |
| 32580920 | Background | 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. |
| 34441778 | Background | 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. |
| 29513640 | Background | 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. |
| 26445857 | Background | 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. |
| 23390618 | Background | 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. |