Dental Implant Supported Removable Dental Prostheses

KU Leuven15 enrolled

Overview

To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Implant Complication Prosthesis Survival

Interventions

placement of implantsPROCEDURE

surgical procedure and placement of implants

immediate loadingPROCEDURE

cone-anchored implant supported removable dental prostheses placement

conventional loadingPROCEDURE

cone-anchored implant supported removable dental prostheses placement in 3mo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of informed consent * Extraction sockets should have healed at least 4 months * Sufficient bone volume to place six implants in the maxilla * No previous bone augmentation procedures * The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established. * Accepting to comply with study procedures Exclusion Criteria: * Physical or psychological disorders prohibiting implant treatment * Heavy smoking (\>10 cigarettes/day) * Present alcohol and/or drug abuse * Physical handicap that may interfere with the ability to perform oral hygiene

Outcomes

Primary Outcomes

bone loss

measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.

Time frame: Difference between loading and Year two

Secondary Outcomes

probing pocket depth

Measurement in mm, 4 sites per implant.

Time frame: Difference between loading and Year two

plaque

presence of plaque, 4 sites per implant, Yes=1 or No=0

Time frame: Difference between loading and Year two

bleeding on probing

presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0

Time frame: Difference between loading and Year two

Data from ClinicalTrials.gov

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