Crowns, Tooth Preparation
Conditions
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.
Interventions
PROCEDUREBiologically-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.
PROCEDUREConventional method of preparation
Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Plaque index | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns. | The plaque index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth, according to Löe and Silness, 1963 |
| Change in the gingival index | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns. | The gingival index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth according to Silness and Löe, 1964 |
| Change in the probing depth | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns. | A UNC periodontal probe will be used to measure the probing depth at the buccal, lingual, mesial, and distal sites of each included tooth. |
| Change in bleeding on probing | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns. | 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 |
| Change in the gingival marginal stability | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns. | 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. |
| Change in the free gingiva thickness | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the internal and marginal adaptation | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation. | 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. |
| Change in the functional and mechanical complications | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation. | 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. |
| Change in the secondary caries status | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation. | 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 |
| Change in the marginal adaptation after crown cementation | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after 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. |
| Change in the color matching | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation. | 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. |
| Change in the clinical success | Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation. | 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. |
| Change in patients' satisfaction | This will be measured at one week and 18 months following cementation. | 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. |
Countries
Syria
Contacts
CONTACTAbeer Aljareh, DDS MSc
CONTACTNabil Alhouri, DDS MSc PhD
PRINCIPAL_INVESTIGATORAbeer Aljareh, DDS MSc
Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
STUDY_DIRECTORNabil Alhouri, DDS MSc PhD
Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
STUDY_DIRECTORMohanad Kadhim, DDS MSc PhD
Department of Periodontology, Faculty of Dentistry, Iraq.
Outcome results
None listed