Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Damascus, DM20AM18, Syria
Location status: Recruiting
Location contact
Abeer Aljareh, DDS MSc
PRINCIPAL_INVESTIGATOR
Nabil Alhouri, DDS MSc PhD
CONTACT
NCT Number: NCT06496828
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.
Interested in participating?
Request Info19 year–80 year
All sexes
Interventional
Not applicable
Damascus, DM20AM18, Syria
Location status: Recruiting
Abeer Aljareh, DDS MSc
PRINCIPAL_INVESTIGATOR
Nabil Alhouri, DDS MSc PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Abeer Aljareh, DDS MSc
CONTACT
Nabil Alhouri, DDS MSc PhD
CONTACT
Damascus University
Other
Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05471024
Bites and Stings, Chemically-Induced Disorders
Giza, Egypt
View Trial DetailsNCT05735509
Crowns
Sant Cugat Del Vallés, Barcelona, Spain
View Trial Details