Unknown
NA
INTERVENTIONAL
NCT03528330
Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
Rehabilitation with dental implant with internal hexagon connection
Type:
DEVICE
Description:
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
Name:
Rehabilitation with dental implant with conical connection
Type:
DEVICE
Description:
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
Primary Outcomes
Measure:
Peri-implant bone level changes
TimeFrame:
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).
Description:
calculated using intraoral digital periapical radiographs
Trial Information
NCT ID
NCT03528330
Status
Unknown
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
University of Valencia
Last Updated
December 15, 2025