Dental Implant Supported Removable Dental Prostheses

Implant Complication Clinical Trial

Official title:

An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041597
• Other study ID #: B32220096198
• Status: Completed
• Phase: N/A
• First received: January 26, 2017
• Last updated: February 1, 2017
• Start date: September 1, 2009
• Est. completion date: December 31, 2015

Study information

• Verified date: February 2017
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implant Complication
• Prosthesis Failure
• Prosthesis Survival

Intervention

Procedure:
• placement of implants
surgical procedure and placement of implants
• immediate loading
cone-anchored implant supported removable dental prostheses placement
• conventional loading
cone-anchored implant supported removable dental prostheses placement in 3mo

Device:
• Ankylos implant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Dentsply Sirona Implants

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone loss	measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.	Difference between loading and Year two
Secondary	probing pocket depth	Measurement in mm, 4 sites per implant.	Difference between loading and Year two
Secondary	plaque	presence of plaque, 4 sites per implant, Yes=1 or No=0	Difference between loading and Year two
Secondary	bleeding on probing	presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0	Difference between loading and Year two