Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage

University of Barcelona

Status: Unknown

Conditions: Dental Implant; Bone Loss; Bacterial Infections

Treatments: Other: Dental Implant Placement

Study type: Interventional

Funder types: Other

Identifiers

NCT04328051

UBarcelonaOralSurgery2

Details and patient eligibility

About

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.

Full description

Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.

Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.

Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

Ocean E.C.®, Avinent Implant System S.L.

Active Comparator group

Description:

Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and external hexagon connection.

Treatment:

Other: Dental Implant Placement

Ocean I.C.®, Avinent Implant System S.L.

Active Comparator group

Description:

Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and internal hexagon connection.

Treatment:

Other: Dental Implant Placement

Ocean C.C.®, Avinent Implant System S.L.

Active Comparator group

Description:

Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and conical connection.

Treatment:

Other: Dental Implant Placement