Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Valencia, 46010, Spain
NCT Number: NCT03528330
This study designed as a randomized controlled split-mouth trial will be conducted at the Dental Clinic of the University of Valencia. The aim will be to assess differences in clinical, radiological and microbiological outcomes between implants with 2 different connections: internal hexagon and conical connection. Following the premises, to minimize the bias related to prosthetic phase and maximize the effect of connections on MBL changes, a 1abutment-1time protocol will be used.
The study hypothesis is that there will be no statistically significant differences between both implant connections.
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Notify Me25 year and older
All sexes
Interventional
Not applicable
Valencia, 46010, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will receive an implant with internal hexagon connection. All implants will be10 mm in length and 3.75 mm in diameter. Implants will be inserted slightly subcrestal. Bone levels will be measured using a calibrated probe.
Torque insertion will be assed using W&H machine Once inserted, implants will be connected to smart pegs to test primary stability.
A periapical x-ray will be done after the operation. Thereafter, a specific coping for digital impression will be connected to the implant and a digital impression will be taken. Aim of this procedure will be to produce a screw retained definitive zirconia prosthesis to be adapted at the time of second surgery
All patients will receive an implant with conical connection. All implants will be10 mm in length and 3.75 mm in diameter. Implants will be inserted slightly subcrestal. Bone levels will be measured using a calibrated probe.
Torque insertion will be assed using W&H machine Once inserted, implants will be connected to smart pegs to test primary stability.
A periapical x-ray will be done after the operation. Thereafter, a specific coping for digital impression will be connected to the implant and a digital impression will be taken. Aim of this procedure will be to produce a screw retained definitive zirconia prosthesis to be adapted at the time of second surgery
Time frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).
calculated using intraoral digital periapical radiographs
Time frame: 3 years
Requiring removal
Time frame: 3 years
Screw loosening or fracture, fracture of the prosthesis or of the ceramic
Time frame: a. implant placement (baseline) b. abutment connection (8-12 weeks)
Measured using Ostell Mentor
Time frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).
Measurement of peri-implant pocket depth with a periodontal probe
Time frame: 12 months after loading
Quantities of different microbial species assessed using 16s metagenomics
Time frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).
Presence or absence of plaque
Time frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).
Presence or absence of bleeding after probing pocket depth
University of Valencia
Other
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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.
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