Clinical Outcomes of Biologically Oriented Preparation Technique
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorDamascus University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients younger than 18.
Parafunctional habits.
Active periodontal disease.
Poor oral hygiene.
Trial design
Design model
Parallel
Treatments tested in this trial
Biologically-oriented preparation technique
Procedure/SurgeryThe preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns.
Conventional method of preparation
Procedure/SurgeryTeeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Biologically-oriented preparation technique (BOPT)Experimental treatment 1 intervention
Group B: Conventional preparationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov