CompletedNot Applicable

Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.

Spain20 participantsStarted 2018-01-08

Plain-language 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.

Who can participate

Age range

25 Years

Sex

ALL

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: * able to sign an informed consent form * aged 25 years or more * Any patient requiring two implant-supported crowns in the lower or upper jaw * Kennedy class I, II, and III; * teeth extracted at least 6 months before implant placement; * sufficient bone volumes to accommodate dental implants without augmentation procedure Exclusion Criteria: * General medical and/or psychiatric contraindications to implant surgery, * Pregnancy or nursing, * Heavy smoking (more than 10 cigarettes/day), * Treatment with anticoagulant drugs (International Normalized Ratio under 1.8), bisphosphonates, steroid therapy or anticonvulsants drugs. * No regenerated bone * Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements. * Patients with history of alcohol, narcotics or drug abuse. (Alcoholism: more than two bottles of beer per day) * Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment, or who have been administered radiotherapy in the last 5 years. (Patients through at any time received radiotherapy to the head and neck region should be excluded anyway.) * Metabolic bone disorders * Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia. * Degenerative diseases. * Osteoradionecrosis. * Renal failure. * Organ transplant recipients. * HIV positive. * Malignant diseases. * Diseases that compromise the immune system. * Unbalanced diabetes …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

Trial details

NCT IDNCT03528330

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

View on ClinicalTrials.gov More Bone Loss, Alveolar trials