The main objective is to evaluate peri-implant hard and soft tissues's stability with the use of a ceramic implant (Implant Straumann®Pure Ceramic) during one year follow up.
Nowadays, the material of choice for the manufacture of dental implants is titanium. However, if we consider the aesthetics, the use of metallic implants can lead to complications, namely metal translucency through the peri-implant mucosa or the presence of soft tissue recessions causing metal exposure. As an alternative to the use of titanium, we have zirconium, that is highly biocompatible and whose use in implantology has demonstrated a predictable osseointegration. In addition, some studies suggest a different histology that could help maintaining the stability of the peri-implant mucosa and, therefore, an improvement in long-term aesthetic results. The reason for designing this study is that there is not too much data about this type of implants, that can be, really, an alternative to those we know. To achieve those objectives a single-arm clinical trial is designed, using marginal bone loss as a primary response variable. It is estimated with the calculation of the sample size, we would need 30 patients to get relevant data. An experienced surgeon (M.V) will perform implant surgery. Later, experienced and calibrated examiners (R.E and E.RG) will collect the following clinical parameters at baseline, and at 4, 8 and 12 months: gingival recession, papillary Jemt index, width and height of the keratinized gingiva, probing depth, plaque index and bleeding on probing. Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The surgical technique begins with the lift of a vestibular mucoperiosteal flap respecting the papillae of the adjacent teeth. After the alveolar bone is exposed, the sequence of drilling and placement of the intra-bone fixation are carried out. In case of fenestrations or dehiscence, they are treated by xenograft and collagen-absorbable membrane. Once the implant is placed, a healing cap or provisional prosthesis is placed depending on the torque achieved. Finally, the flap is replaced and sutured.
Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
Leioa, Biscay, Spain
Marginal bone level change (MBLC)
Distance between the mesial/distal marginal crests and the first implant thread. This is calibrated based on the known length (1,8 mm) of the machined neck.
Time frame: Change from baseline until 12 months
Gingival recession (REC)
Distance in mm from incisal edge to gingival margin.
Time frame: Change from baseline (when the crown is cemented) until 12 months.
Jemt Papilla index score (JPIS)
This score ranges from 0 to 3. Index score 0 denotes no soft tissue in the area; index score 1 denotes soft tissue reaching less than half the distance between the reference line and the contact point; index score 2 denotes more soft tissue than indicated by index score 1 but not extending all the way to the contact point; and index score 3 denotes tissue filling the entire embrasure.
Time frame: Change from baseline until 12 months.
Surgical complications (SC)
Any complication, as bleeding, dehiscence, loss of suture, etc... that may appear will be collected.
Time frame: Surgery and the next 7 days.
Prosthetic complications (PC)
Any difficulty during the confection of the crown, complications as descementation, chipping, etc... will be registered.
Time frame: Baseline, 4, 8 and 12 months.
Probing depth (PD)
Distance in mm from the gingival margin to the bottom of peri-implant pocket. It will be recorded in 6 points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual).
Time frame: Baseline, 4, 8 and 12 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bleeding on probing (BOP)
Presence or not of bleeding after probing. It will be recorded in 6 points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual).
Time frame: Baseline, 4, 8 and 12 months.
Plaque index (PI)
A plaque developer is used and the presence of plaque is recorded at 6 points per tooth/implant and the percentage of sites with plaque is calculated (O'Leary et al 1972).
Time frame: Baseline, 4, 8 and 12 months.
Width of keratinized tissue (WKT)
Distance in mm from the mucogingival junction to the gingival margin, measured at the vestibular midpoint.
Time frame: Baseline and 12 months.
Thickness of keratinized tissue (TKT)
The thickness of the gingiva around the implant is measured approximately 2 mm apical to gingival margin on the facial aspect of the implant. After topical application of anesthetic, the thickness is measured by gently inserting a 27-gauge needle with a rubber stopper in the tip until the underlying hard structure had been contacted. The distance between the tip of the needle and the rubber stopper is measure with a periodontal probe.
Time frame: Baseline and 12 months