Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Proed
ClinicalTrials.gov Identifier:
NCT01807416
First received: March 7, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.

80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.

Data will refer to the following timing:

T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.

Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.

Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.


Condition Intervention Phase
Jaw, Edentulous, Partially
Procedure: implant insertion and abutment connection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

Further study details as provided by Proed:

Primary Outcome Measures:
  • Marginal Bone Level [ Time Frame: 1 year after implant installation ] [ Designated as safety issue: No ]
    On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured


Secondary Outcome Measures:
  • Probing Pocket Depth [ Time Frame: 1 year after implant installation ] [ Designated as safety issue: No ]
    Probing depth measured mesially, buccaly, distally and lingually at implant site

  • Bleeding on Probing [ Time Frame: 1 year after implant installation ] [ Designated as safety issue: No ]
    Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site


Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard platform , standard abutment
implant insertion and abutment connection Osseointegrated implants with regular collar connected to standard designed prosthetic abutments
Procedure: implant insertion and abutment connection
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Active Comparator: standard platform, flat abutment
implant insertion and abutment connection Osseointegrated implants with regular collar connected to flat designed prosthetic abutments
Procedure: implant insertion and abutment connection
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Active Comparator: switching platform, standard abutment
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to standard designed prosthetic abutments
Procedure: implant insertion and abutment connection
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Active Comparator: switching platform, flat abutment
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to flat designed prosthetic abutments
Procedure: implant insertion and abutment connection
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected

Detailed Description:

BACKGROUND:

Platform switching is intended to preserve marginal bone around implants. Studies have shown that implants using an integrated platform switching demonstrate crestal bone loss as low as 0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to modulate the soft tissue integration around implant supported crowns. A new implant with a hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated platform switching (Prevail) or non platform switching (Standard Collar).

Aim of the present study will be to evaluate if the platform switching and the Tissuemax abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.

MATERIALS & METHODS:

80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. Implants should be inserted in preexisting adequate bone volume, without the need for any bone augmentation technique. Implants will be inserted with a transmucosal healing (single-stage surgical procedure) with immediate connection of the healing abutment. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.

Data will refer to the following timing:

T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.

Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments The division into the 4 group will be randomized. Standardized intraoral radiograms will be done at T0, T1, T2 and T3. On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.

Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy adult patients with partial edentulism

Exclusion Criteria:

  • Current pregnant patients
  • History of malignancy
  • History of radiotherapy or chemiotherapy in the last 5 years
  • Long term steroidal or antibiotic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807416

Locations
Italy
PROED, Institute for Professional Education in Dentistry
Torino, TO, Italy, 10129
Sponsors and Collaborators
Proed
Investigators
Study Director: Daniele Cardaropoli, DDS Proed
  More Information

No publications provided

Responsible Party: Proed
ClinicalTrials.gov Identifier: NCT01807416     History of Changes
Other Study ID Numbers: 02.2013.Piemonte.PROED
Study First Received: March 7, 2013
Last Updated: January 27, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Proed:
Osseointegrated Implant, Bone level

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on August 28, 2014