Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage (NCT04328051) | Clinical Trial Compass
UnknownNot Applicable
Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage
Spain105 participantsStarted 2018-06-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
* ≥18-years-old patients.
* Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
* Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
* O'Leary plaque index and or bleeding on probing ≤25%.
* Dental implants with screwed-retained prosthesis.
Exclusion Criteria:
* Systemic diseases that can interfere dental implant placement.
* Any contraindication for surgery procedures.
* Heavy smokers (\> 20cig/day).
* Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
* Patients who have had participated with another clinical trial the last 30 days.
* Pregnant women or in lactation.
* Patients with bad oral hygiene or not motivated.
* Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
* Guided bone regeneration required in the same time of the implant placement.
What they're measuring
1
Change in Vertical Marginal Bone Loss (VMBL)
Timeframe: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.