This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.
Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®. Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Antibiotic prophylaxis will be done. After rinsing with 0.12 % chlorhexidine, patients will receive local anaesthesia. A crestal incision will be done and a mucoperiostic flap will be raised. As the commercial specifies, progressive diameter drills will be used under constant sterile saline irrigation to prepare the implant site. Once finished the drilling sequence, one investigator will open the opaque envelope to know which type of implant, depending on the connection, has to be placed by the surgeon. Dental implant will be placed crestally and depending if it has primary stability or not, it will be leaded submerged or non-submerged. The flap will be repositioned and sutured without tension with 4/0 polyamide. Postoperative instructions and medication will be prescribed and explained.
University of Barcelona
L'Hospitalet de Llobregat, Catalonia, Spain
RECRUITINGChange in Vertical Marginal Bone Loss (VMBL)
Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.
Time frame: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Vertical Marginal Bone Loss Tax
Vertical bone loss in millimetres per implant and unit of time.
Time frame: 12 months after prosthesis placement.
Early implant failure
Implant with mobility or failure of the osseointegration process before the prosthesis placement.
Time frame: Since implant placement (Timing 0) through prosthesis placement (Timing 1).
Late implant failure
Implant with mobility or failure of the osseointegration process after the prosthesis placement.
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Probing pocket depth
Distance in millimetres from the gingival margin to the bottom of the periodontal pocket measured with the periodontal probe. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal recession
Distance in millimetres from the cemento-enamel junction of the tooth or from the implant platform to the gingival margin when it is located apically. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Mucosal hyperplasia
Distance in millimetres from the gingival margin to the cemento-enamel junction of the tooth or to the implant platform when the gingiva is located more coronal than them. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Clinical attachment level
Probing pocket depth (mm) plus the recession (mm) or probing pocket depth minus the hyperplasia (mm). Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
O'Leary plaque index
Plaque presence in the dentogingival or implantogingival union. Determined in four points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual). Expressed as the percentage (%) of tooth or implant surfaces with plaque presence divided with the total of tooth or implant surfaces in mouth and multiplied per 100.
Time frame: First visit
Bleeding on probing
Presence of blood in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with blood divided with the total of tooth or implant surfaces in mouth and multiplied per 100.
Time frame: Since first visit through study completion (Timing 5), an average of 1 year.
Suppuration on probing
Presence of purulent material in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with pus divided with the total of tooth or implant surfaces in mouth and multiplied per 100.
Time frame: Since first visit through study completion (Timing 5), an average of 1 year.
Prosthetic complications
Screw (which connects the crown with the implant) fracture or prosthesis fracture, chipping of the ceramic prosthesis, loosening of the screw (which connects the crown with the implant) or any other prosthetic components.
Time frame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Bacterial leakage
Quantitative PCR in real time to determine the total amount of bacteria and in particular, of 10 pathogenic species: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia, Peptostreptococcus micros, Fusobacterium nucleatum, Campylobacter rectus, Eikenella corrodens and Candida albicans.
Time frame: 12 months after prosthesis placement.