Clinical Outcomes of Biologically Oriented Preparation Technique
NCT Number: NCT06496828
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Crowns|Tooth Preparation
Interventions: PROCEDURE: Biologically-oriented preparation technique|PROCEDURE: Conventional method of preparation
Sponsor: Damascus University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-30
Completion Date: 2027-12-30
Locations: Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria, Damascus, DM20AM18, Syrian Arab Republic

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.

Primary Outcome Measures: 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: 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.