An interventional study of Biologically-oriented preparation technique and Conventional method of preparation in Crowns and Tooth Preparation, sponsored by Damascus University. Recruiting at 1 site in Syria. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Patients in this group will undergo the biologically-oriented preparation technique.
Procedure: Biologically-oriented preparation technique
Patients in this group will undergo the convention preparation technique.
Procedure: Conventional method of preparation
The preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns.
Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns
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
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
The gingival index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth according to Silness and Löe, 1964
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
A UNC periodontal probe will be used to measure the probing depth at the buccal, lingual, mesial, and distal sites of each included tooth.
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
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
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
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.
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
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
Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.
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.
Time frame: 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.
Time frame: 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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This will be measured at one week and 18 months following cementation.
Plan to share: No
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